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Keeping with its mission of offering a comprehensive array of services to patients, The Cancer Institute of New Jersey (CINJ) has expanded its Urologic Oncology Program, which has gained formal recognition as a Section of Urologic Oncology under the Department of Surgery at UMDNJRobert Wood Johnson Medical School. The program provides highly specialized care for patients with tumors of the genitourinary tract including cancers of the prostate, testis, kidney, and bladder. CINJ is a Center of Excellence of UMDNJRobert Wood Johnson Medical School.

CINJs Section of Urologic Oncology is a leader in laparoscopic renal procedures and has extensive experience with robotic prostatectomy, which boasts such patient benefits as shorter hospital stays, lower blood loss, and faster recovery. Leading this effort is Isaac Yi Kim, MD, PhD, associate professor of surgery at UMDNJRobert Wood Johnson Medical School, who is an expert in the area of robotic prostatectomy and developed the Athermal Intrafascial Robotic or AIR prostatectomy. The AIR procedure spares more nerves than the traditional method and leads to faster recovery of sexual function and bladder control. CINJ has developed a Center of Excellence for robotic surgery and Kim and colleagues have performed more than 550 robotic prostatectomies over the last four years alone.

In addition to its extensive prostate cancer focus, the Section of Urologic Oncology is also building on its excellence in bladder and kidney cancers, having just recruited a pair of urologic oncologists with special expertise in these areas. Michael E. Karellas, MD, is a urologic oncologist at CINJ and an assistant professor of surgery at UMDNJRobert Wood Johnson Medical School. Dr. Karellas, who recently completed fellowship training at Memorial SloanKettering Cancer Center (MSKCC), has a clinical interest in the treatment of bladder cancer. Thomas L. Jang, MD, MPH, is a urologic oncologist at CINJ and an assistant professor of surgery at UMDNJRobert Wood Johnson Medical School, who specializes in kidney cancer. Dr. Jang, who also just completed fellowship training at MSKCC, will be responsible for building the programs new prostate cancer database, which will link histological and clinical data from prostate cancer tumors in an effort to further facilitate translational research.

The Section of Urologic Oncology and the Dean and Betty Gallo Prostate Cancer Center offer a wide breadth of clinical trials for patients with tumors of the genitourinary tract as well as several trials studying the prevention of prostate cancer. In addition, the Dean and Betty Gallo Prostate Cancer Center provides a hub for basic and clinical research specific to prostate cancer and serves as a forum for prostate cancer outreach and education activities.

“I am thrilled to welcome Drs. Karellas and Jang to New Jerseys only National Cancer Institutedesignated Comprehensive Cancer Center,” said Dr. Kim. “Their experience complements an already strong team with varied and unique expertise and will help us grow the program even more.”

Additional information about CINJs Urologic Oncology Program can be found at cinj.org/treatment/urologic.html.

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Researchers are developing a Wearable Artificial Kidney for dialysis patients, reports an upcoming paper in the Clinical Journal of the American Society of Nephrology (CJASN). “Our vision of a technological breakthrough has materialized in the form of a Wearable Artificial Kidney, which provides continuous dialysis 24 hours a day, seven days a week,” comments Victor Gura, MD (David Geffen School of Medicine at UCLA).

The device essentially a miniaturized dialysis machine, worn as a belt weighs about 10 pounds and is powered by two ninevolt batteries. Because patients dont need to be hooked up to a fullsize dialysis machine, they are free to walk, work, or sleep while undergoing continuous, gentle dialysis that more closely approximates normal kidney function.

Such a device could lead to a “paradigm change” in the treatment of dialysis patients. Despite enduring long hours on dialysis every week with major limitations in activities, diet, and other areas of life dialysis patients face high rates of hospitalization and death. The U.S. dialysis population currently exceeds 400,000, with costs of over $30 billion per year. “We believe that the Wearable Artificial Kidney will not only reduce the mortality and misery of dialysis patients, but will also result in significant reduction in the cost of providing viable health care,” says Gura.

The Wearable Artificial Kidney is successful in preliminary tests, including two studies in dialysis patients. The new study provides important information on the technical details that made these promising results possible.

“However, the longterm effect of this technology on the wellbeing of dialysis patients must be demonstrated in muchneeded clinical trials,” adds Gura. “Although successful, this is but one additional step on a long road still ahead of us to bring about a muchneeded change in the lives of this population.”

Other authors were Alexandra S. Macy, Masoud Beizai, and Carlos Ezon (Xcorporeal, Inc); and Thomas A. Golper, MD (Vanderbilt University Medical Center). Dr. Gura receives a salary from Xcorporeal, Inc.

Additionally, significant contributions to the development of this new device were made by Hans Dietrich Polaschegg, PhD, Andrew Davenport, MD, Claudio Ronco MD, Andre Kaplan, MD, and Eli Friedman, MD.

The study entitled, “Technical Breakthroughs in the Wearable Artificial Kidney (WAK),” appeared online at cjasn.asnjournals.org/ on August 20, 2009, doi 10.2215/CJN.02790409.

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Shari Leventhal

UroToday.com Patients with T1 bladder cancer have an uncertain natural history. It is clear that patients who are allowed to progress to muscle invasive disease have similar survival to patients who present initially with muscle invasive disease.

Currently, there are few markers that are available to predict which patients will progress to muscle invasive disease and need earlier, more aggressive intervention.

Time to definitive therapy has been shown to be critical in the survival of patients with invasive bladder cancer. This is important for patients with T1 bladder cancer because the risk of understaging occurs in up to 30% of patients. While a restaging transurethral resection can help identify those patients who have been understaged, we performed the current study to determine other histologic features that may be associated with the risk of understaging. Invasion of the muscularis mucosae (when present), urethral involvement, and divergent histology all increased the risk of understaging, and the cumulative effect of having all three adverse features increased the odds of understaging 20fold.

While these features do not replace the need for a restaging transurethral resection of the bladder, their presence on the initial biopsy may guide clinicians to recommend earlier more definitive therapy with T1 disease potentially reducing the timeline to proceed to more aggressive management such as radical cystectomy and urinary diversion.

Written by Alon Z. Weizer, MD as part of Beyond the Abstract on UroToday.com

UroToday the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go tourotoday.com

Roche Diagnostics launches campaign to promote widest panel of assays on an automated serum work area platform

As concerns are raised about the expense of treatments for chronic diseases such as osteoporosis and kidney disease and for infectious diseases such as Hepatitis C and HIV, Roche Diagnostics launches a nationwide promotion of its 183strong panel of high sensitivity assays, designed to provide the best possible test accuracy and efficiency for improved patient care.

The campaign focuses on three key disease areas

Osteoporosis

According to the World Health Organisation (WHO), osteoporosis is second only to cardiovascular disease as a global health problem. The incidence of osteoporosis is set to increase with the ageing of the population and in the UK one in two women and one in five men over the age of 50 will break a bone mainly because of poor bone health.

The new and comprehensive range of Roche Elecsys ® bone marker assays are set to help make a major impact on the way in which osteoporosis is treated in the UK. Now with this detailed test, the consultant can gain an holistic overview of a patients bone status giving clear guidance on the most appropriate treatment with the lowest level of sideeffects.

Chronic Kidney Disorder

Chronic kidney disorder effects one in 10 people aged 5564, and one in two of those aged 75 or over. Having chronic kidney disorder puts the individual at an increased risk of heart attack or stroke, and therefore rapid diagnosis and treatment is critical.

The Roche Creatinine Plus enzymatic creatinine assay, is a highly reliable test used on patients with chronic kidney disease. It is designed to give extreme test accuracy in the monitoring of pre and posttransplant patients. Amongst the many users are St Thomas Hospital London, and University Hospitals Coventry and Warwickshire Trust. With each hospital performing over 30,000 tests every month, the assay provides a more accurate assessment of renal function and has already enabled improved patient care.

Infectious Disease

Infectious diseases such as Hepatitis B and C and HIV remain at higher levels than the 1990s. The Roche Serology portfolio offers the widest range of assays for detecting infectious diseases including Hepatitis B (HBV) and Hepatitis C (HCV) and HIV. The latest components in this portfolio are the cobas Anti HCV, a rapid and sensitive screening assay for detecting antibodies of the Hepatitis C virus. This allows for diagnosis in early stages of HCV, and other assays in the portfolio are used in the detection of Rubella and Syphilis.

Roches groundbreaking 183 strong assay portfolio which is available on an automated serum work area platform represents stateoftheart laboratory testing in the UK. The tests provide consultants with the most accurate information available for making treatment decisions whilst increasing consolidation opportunities and improving testing efficiencies.

Ian Parfrement, Roche Diagnostics HIVD Director UK, and Ireland said “The release of these new assays to the Hospital in vitro diagnostic market demonstrates Roches continued commitment to innovation and is an integral part of Roches overall strategy in diagnostics for providing information of real value to healthcare professionals. Not only are we aiming to push test accuracy to its boundaries, we aim to help managers in hospitals make the most effective use of limited diagnostic budgets. We have had huge interest in the campaign from customers all over the UK.”

Surgical teams at The Johns Hopkins Hospital, BarnesJewish Hospital in St. Louis, INTEGRIS Baptist Medical Center in Oklahoma City and Henry Ford Hospital in Detroit successfully completed the first eightway, multihospital, domino kidney transplant. The transplant involved eight donors 3 men and 5 women along with eight organ recipients 3 men and 5 women. “All Johns Hopkins patients are in good condition and are recovering as anticipated,” according to Robert A. Montgomery, M.D., Ph.D., director of the Johns Hopkins Comprehensive Transplant Center.

The procedure, kidney paired donation (KPD), takes a group of incompatible donorrecipient pairs (recipients coming to one of the four hospitals with a willing donor who is not compatible by blood or tissue) and matches them with other pairs in a similar predicament. By exchanging kidneys between the pairs, it is possible to give each recipient a compatible kidney. In this way, each recipient receives a kidney from a stranger, and transplants are enabled that otherwise would not have taken place. Involving multiple hospitals created even more possibilities for matches, but it also made the procedure more complex.

“We performed a similar sixway domino procedure involving three hospitals earlier this year,” says Montgomery. “We managed to perform all those surgeries on the same day. However, adding two more recipients, two more donors and another hospital meant that we needed a multihospital team of eight anesthesiologists, 16 nurses and nine surgeons. The logistics being that much more complicated, we decided it was best to spread the surgeries over several days, the first on June 15 and the last, July 6.”

Aside from sheer logistics, performing large numbers of transplants on one day puts a lot of strain on the doctors, nurses and staff at each hospital, says Montgomery, and also ties up too many operating rooms.

He says this new model will serve as a blueprint for a national KPD program in which kidneys will be transported around the country, resulting in an estimated 1,500 additional transplants each year.

An altruistic donor started the domino effect. Altruistic donors are those willing to donate a kidney to any needy recipient. Just like falling dominoes, the altruistic donor kidney went to a recipient from one of the incompatible pairs, that recipients donors kidney went to a recipient from a second pair and so on. The last remaining kidney from the final incompatible pair went to a recipient who had been on the United Network for Organ Sharing (UNOS) waiting list.

One of the donors in this procedure was the Pamela Paulk, the vice president of human resources at The Johns Hopkins Hospital and Johns Hopkins Health System. Paulk, a longtime supporter of kidney donation, decided to donate to a friend and colleague who lost function of his kidneys three years ago.

“I always knew I was going to donate. I was just waiting for the right time, and this was the right time,” says Paulk, whose surgery took place on June 22. Paulk joins roughly 100,000 Americans since 1988 who have generously donated a kidney to needy recipients, according to data from the UNOS Web site. As encouraging as that sounds, 84,000 people in the United States alone are currently listed by UNOS as needing a kidney. With only about 6,000 people donating kidneys annually, we are a long way from eliminating this problem, says Montgomery.

As part of this complex procedure, Johns Hopkins flew one kidney to Henry Ford, one kidney to INTEGRIS Baptist and one kidney to BarnesJewish, In exchange, Henry Ford, INTEGRIS Baptists and Barnes Jewish each flew a kidney to Johns Hopkins.

The 16 surgeries were performed on four different dates, June 15, June 16, June 22 and July 6. The 10 surgeons in charge included four at Johns Hopkins, two at INTEGRIS Baptist, two at BarnesJewish and two at Henry Ford.

Johns Hopkins surgeons performed one of the first KPD transplants in the United States in 2001, the first tripleswap in 2003, the first double and triple domino transplant in 2005, the first fiveway domino transplant in 2006 and the first sixway domino transplant in 2007. Johns Hopkins also performed the first multihospital, transcontinental threeway swap transplant in 2007 and the first multihospital, transcontinental sixway swap transplant in 2009.

Nearly 100 medical professionals took part in the transplants, including immunogeneticists, anesthesiologists, operating room nurses, nephrologists, transfusion medicine physicians, critical care doctors, nurse coordinators, technicians, social workers, psychologists, pharmacists, financial coordinators and administrative support people.

The other surgeons who participated in the surgery were Mohamad Allaf, M.D., Andrew Singer, M.D., and Dorry Segev, M.D., from the Johns Hopkins Department of Surgery; Scott Samara, M.D., and Shea Samara, M.D., from INTEGRIS Baptist Medical Center; Surendra Shenoy, M.D., Ph.D., and Martin Jendrisak, M.D., from BarnesJewish Hospital; and Dean Kim, M.D., and Lauren E. Malinzak, M.D., from Henry Ford Hospital.

Source
John Lazarou

Billing claims from health insurance companies can provide insights on the longterm health of kidney transplant patients, according to a study appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology (CJASN). The findings indicate that valuable health information can be obtained by analyzing medical insurers reimbursement documents, a process that is much simpler and cheaper than many other forms of clinical investigation.

Patients who receive kidney transplants have an increased risk of developing a variety of serious complications, but transplant centers rarely collect detailed followup information on the health of organ recipients in readily analyzable formats. Researchers are therefore looking for information that may be available from other sources, such as from health insurance databases. Insurance companies billing claims provide records of physician visits, hospitalizations, and medical procedures that could be used to conduct timely, costeffective, and unobtrusive research on large populations.

To assess the ability of using billing claims to track transplant patients longterm health, Krista Lentine, MD (Saint Louis University Center for Outcomes Research), and her colleagues compared information from Medicare billing claims from 571 transplant patients with information from actual patient medical records. They specifically looked at whether billing claims documented cardiovascular diagnoses and procedures as accurately as patients electronic medical records.

The researchers found that combined use of Medicare billing claims from both Medicare Part A and Part B provided a sensitive record of cardiovascular events after kidney transplantation. The billing claims correctly identified 83.3% to 100% of cardiovascular events noted in patients medical records. Documentation of cardiovascular procedures such as coronary bypass surgery and cardiac catheterization was particularly accurate.

The authors hope that this study will lead to future investigations on the value of billing claims in other types of research. Conducting randomized clinical trials is the best way to assess medical information, but these studies are expensive and timeconsuming. Administrative data from insurance billing claims may help answer a number of clinical questions and describe health outcomes in large patient populations in an efficient and inexpensive way. Billing claims could be an attractive research tool at a time when the nation is striving to reduce medical costs while maintaining or improving quality.

The authors report no financial disclosures. Study coauthors include Mark Schnitzler, PhD, and Paula Buchanan, MPH (Saint Louis University Center for Outcomes Research); Kevin Abbott, MD (Walter Reed Army Medical Center); Kosha Bramesfeld, PhD (Saint Loius University Graduate School); and Daniel Brennan, MD (Washington University School of Medicine).

Founded in 1966, the American Society of Nephrology (ASN) is the worlds largest professional society devoted to the study of kidney disease. Comprised of 11,000 physicians and scientists, ASN continues to promote expert patient care, to advance medical research, and to educate the renal community. ASN also informs policymakers about issues of importance to kidney doctors and their patients. ASN funds research, and through its worldrenowned meetings and firstclass publications, disseminates information and educational tools that empower physicians.

In recent decades, there have been periodic reports of a worldwide decline in sperm count and quality. Male infertility has ostensibly been on the rise, accompanied by increases in testicular cancer and hypospadias a congenital defect in which the opening of the urethra is on the underside, rather than at the end, of the penis. Taken together, these three conditions have been termed testicular dysgenesis syndrome.

Environmental chemicals known as phthalates, some researchers say, may be the cause of the problem. Used in the manufacture of plastics, phthalates at sufficiently high levels have been seen to interfere with male fetal development. Some studies have found that hypospadias are more prevalent among male infants today than they were 30 years ago.

Now, a team of researchers based at NewYorkPresbyterian Hospital/Columbia University Medical Center and Childrens Hospital of Philadelphia have taken a fresh look at the data and have found no rise in rates of hypospadias in New York State from 1992 to 2005. Similar findings have been reported by researchers looking at statelevel data in Washington and California.

These studies break the link between the purported cause phthalates and their presumed effect impaired male reproductive health, says Dr. Harry Fisch, director of the Male Reproductive Center at NewYorkPresbyterian Hospital/Columbia University Medical Center and professor of clinical urology at Columbia University College of Physicians and Surgeons.

“Its all in the data,” says Dr. Fisch. “For one, the entire method of collecting data on birth defects has changed. Statewide surveillance of birth defects has become the norm. This calls into question the value of the older data.

“Second,” he adds, “we cant assume that these chemicals are harmful at low, environmentally allowable levels just because weve seen high rates of exposure to phthalates in utero have been linked to hypospadias in animal studies.”

In the study, Dr. Fisch and and his colleagues reviewed the total number of cases of hypospadias in New York State from 1992 to 2005 and found no statistically significant increase during that interval. These findings have just been published in the May 2009 issue of the Journal of Urology. Coauthors included Drs. Terry W. Hensle and Grace Hyun of NewYorkPresbyterian Hospital/Columbia University Medical Center, and Dr. Sarah M. Lambert of Childrens Hospital of Philadelphia.

When combined with recent research showing that sperm counts are not declining, the current study suggests that testicular dysgenesis syndrome may not be a problem in humans, contrary to earlier concerns.

The only significant risk factor for hypospadias that emerged from Dr. Fischs research is maternal age. Children of mothers aged 35 years and older show higher rates of the birth defect a finding that is consistent with other recent epidemiological studies.

Most hypospadias can be surgically repaired in the first year of life by a pediatric urologist.

More on Phthalates

In July 2008, Congress approved a ban on the use of phthalates in childrens products, such as teething rings, rubber ducks, and soft toys. However, these chemicals are ubiquitous in todays environment. Also known as plasticizers, they are found in shampoo, pharmaceuticals, medical supplies, pesticides, plastic wrap, garden hoses, and plastic clothing, among other common products.

Given their suspected detrimental effects at high levels of concentration, questions arise around how to regulate phthalates and other humanmade environmental chemicals.

“Environmental chemicals need to be regulated,” says Dr. Fisch, “but policies should be based on science, not fear.”

Columbia University Medical Center

Columbia University Medical Center provides international leadership in basic, preclinical and clinical research, in medical and health sciences education, and in patient care. The Medical Center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbias College of Physicians and Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States.

NewYorkPresbyterian Hospital

NewYorkPresbyterian Hospital, based in New York City, is the nations largest notforprofit, nonsectarian hospital, with 2,242 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including more than 230,000 visits to its emergency departments more than any other area hospital. NewYorkPresbyterian provides stateoftheart inpatient, ambulatory and preventive care in all areas of medicine at five major centers NewYorkPresbyterian Hospital/Weill Cornell Medical Center, NewYorkPresbyterian Hospital/Columbia University Medical Center, NewYorkPresbyterian Morgan Stanley Childrens Hospital, NewYorkPresbyterian Hospital/The Allen Pavilion and NewYorkPresbyterian Hospital/Westchester Division. One of the largest and most comprehensive health care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. NewYorkPresbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. The Hospital has academic affiliations with two of the nations leading medical colleges Weill Cornell Medical College and Columbia University College of Physicians and Surgeons.

Researchers in the University of Virginia Department of Urology have developed a novel method that could help physicians determine the best course of treatment for patients suffering from bladder cancer.

Bladder cancer is typically treated by neoadjuvant chemotherapy, a treatment in which chemotherapy is administered to reduce the size of the cancer prior to surgery, with the two most commonly used chemotherapeutic regimens being MVAC (methotrexate, vinblastine, adriamycin and cisplatin) and GemCis (gemcitabine and cisplatin). While MVAC has long been considered the more potent regimen and is often offered as the gold standard for treatment, it is quite toxic and known to successfully treat only about 25 percent of patients who receive it. Recent studies in metastatic cancer suggest that GemCis is equally potent and may be better tolerated among patients; thus, it is commonly used in the neoadjuvant setting.

Dan Theodorescu, M.D., Ph.D., and colleagues have discovered biomarkers whose expression in patients urine could accurately predict whether or not a patient is likely to respond to MVAC treatment. The biomarkers may also predict the likelihood of a successful outcome using the GemCis treatment. This novel, bioinformatics approach to predicting the success of a particular treatment over other regimens could lead to customized, moreeffective treatment for bladder cancer patients.

“This is a promising, inexpensive and minimally invasive potential approach to evaluate patients prior to neoadjuvant chemotherapy,” said Theodorescu, professor of urology and molecular physiology and director of the Paul Mellon Urologic Cancer Institute at U.Va.

The U.Va. Patent Foundation has filed a patent application on the use of these biomarkers as a diagnostic tool and is currently seeking an industrial partner to further develop and commercialize the discovery. The biomarkers can easily be evaluated by ELISA (EnzymeLinked Immunosorbent Assay) testing or similar technology in the urine.

“This exciting new tool could enable physicians to determine not only whether to proceed with treatment for bladder cancer, but also which treatment would be effective, on a casebycase basis,” said Mikael C. Herlevsen, Ph.D., licensing associate at the U.Va. Patent Foundation. “This innovative technology shows a great deal of promise and could have a real impact on patients lives.”

The National Cancer Institute of the National Institutes of Health estimates more than 70,000 men and women throughout the U.S. will be newly diagnosed with bladder cancer in 2009

About the University of Virginia Patent Foundation

The University of Virginia Patent Foundation is a notforprofit corporation that serves to bring U.Va. technologies to the global marketplace by evaluating, protecting and licensing intellectual property generated in the course of research at U.Va. The Patent Foundation reviews and evaluates nearly 200 inventions per year and has generated approximately $85 million in licensing revenue since its formation in 1978.

Source University of Virginia