|
February 1, 2000
News this month
Will new urine tests replace uncomfortable cancer diagnostic tests?
A group of researchers at Cambridge University recently reported
on a new type of bladder cancer test that might someday replace
other less convenient methods currently used to screen for this
disease. According to a report in the Oct. 30 issue of Lancet,
the team hopes that someday the test might be used to screen for
colon, prostate and kidney cancers.
Encouraging results
The researchers used the test on 36 patients who had blood in their
urine. Such a symptom is seen in bladder cancer, but can also be
caused by infection, bladder stones or kidney disease. Of the 36
patients tested, the urine test accurately detected bladder cancer
in eight patients. These patients' diagnoses were later confirmed
through surgical biopsy. A ninth patient tested positive, but later
was diagnosed with an ulcer of the bladder.
The patients also received X-rays of the upper urinary tract and
cystoscopy within 12 hours of giving the urine sample. During cystoscopy,
physicians view the inside of the bladder by guiding a thin tube
that holds a lens and a light up the urethra.
One major hurdle in designing new diagnostic tests
is reducing the number of false positives and false negatives.
Test detects protein shed by cancer cells
The urine test works by detecting a protein called Mcm5, which is
involved in the normal replication of DNA in all cells. In bladder
cancer patients, however, this protein is shed in excessive amounts
into the urine. For this study, the scientists took the urine sample,
isolated the Mcm5 protein, and stained the cells using a special stain
for that type of protein. They then examined the cells under a microscope
for the presence of the protein.
One major hurdle in designing new diagnostic tests is reducing the
number of false positives and false negatives. In this study, there
was only one false positive in the patient with a chronic infection.
Importantly, in five of the 28 noncancerous cases, inflammatory cystitis
was detected but did not give a false positive reading. While seven
of the patients had bladder cancer, an eighth patient had cancer of
the ureter, giving hope to the researchers that their test might be
used to detect cancers of the bladder, ureter or kidney.
Big push toward new urine tests
This study enters a crowded field of research into urine tests that
have shown promise in detecting bladder cancer. Agents under investigation
or recently introduced into the market include:
- Urine telomerase activity
- Urine Bladder Tumor-associated Antigen ("BTA Stat")
- Urine Nuclear Matrix Proteins ("NMP22")
- Urine fibrin/fibrinogen degradation products
- Urine ultrasensitive assay for hemoglobin
Global research interest
Researchers at the Cleveland Clinic reported success with NMP22, in
the January issue of Urology. In the February issue, another
team from Israel reported success using BTA to detect bladder cancer
in patients with blood in the urine and other symptoms. In that same
issue, researchers compared the sensitivity and specificity of urine
cytology, BTA stat, NMP22, fibrin/fibrinogen degradation products
(FDP), telomerase, chemiluminescent hemoglobin and hemoglobin dipstick
to detect bladder cancer. Telomerase showed the most promise. In May,
researchers at the University of Pittsburgh published encouraging
results in Urology Times using yet another protein, BLCA-4,
which appears to be expressed throughout the bladders of patients
with bladder cancer but not in patients who are cancer free.
In February, the U.S. Food and Drug Administration
gave approval to an at-home urine test using BTA to detect recurrent
bladder cancer,
New tests for bladder cancer recurrence
Much of the focus has been on developing tests to check for bladder
cancer recurrence. In February, the U.S. Food and Drug Administration
gave approval to an at-home urine test using BTA to detect recurrent
bladder cancer, and allowed physicians to use BTA and NMP22 in their
offices and approved labs to detect recurrent bladder cancer.
Physician Referral Online
A free and confidential service
of Yale-New Haven Hospital.
Physician Referral Online
Using your own criteria, you can request information from a database
of 900 area physicians who have registered to participate.
Request an appointment
We would be happy to assist you in scheduling an appointment with
a member of the hospital's medical staff. Use the link above or
call:
203-688-2000
or toll free
1-888-700-6543
to talk with a referral coordinator.
|

|
Urinary bladder
cancer is the fifth most common cancer in the U.S., but diagnosing
the disease can be difficult. Unlike breast or prostate cancers,
there are no widely accepted bladder cancer screening tests that
are quick, easy and relatively pain free. Despite the promise of
new tests, the best way to accurately diagnose bladder cancer remains
performing cystoscopy and biopsy. No new urine test has yet approached
the accuracy of cystoscopy.
"The best way to accurately diagnose bladder cancer remains
performingcystoscopy and biopsy."
A crowded field of new tests
Because of the pain and expense incurred to the patient, scientists
have long searched for a noninvasive test that offered sufficient
accuracy. The market is now crowded with several new bladder cancer
screening tests that detect tumor markers, but their use remains limited.
Those who require testing are either suspected of having bladder cancer
or have had the cancer and are checking for recurrence. Symptoms of
bladder cancer include:
- visible blood in the urine;
- pain during urination; and
- frequent urination or feeling to go without results.
Anyone who experiences these symptoms should have a thorough exam
to rule out other ailments. Cigarette smokers have a rate of bladder
cancer two to three times higher than nonsmokers do. Exposure to certain
chemicals also increases risk for developing bladder cancer later
in life.
Cystostopy explained
For diagnosis, a urologist views the inside of the bladder through
a cystoscope, which is like a telescope with a light on the end of
it. During this procedure, which can be done in a physician's office,
the inside of the bladder is examined. If any abnormalities are seen,
more tests may be required to determine if the cancer is localized
or has spread beyond the bladder.
About 80-85 percent of bladder cancer patients are diagnosed with
early stage cancers that originate in transitional cells. These cells
are found along the surface of the inside of the bladder, in the ureter
tubes that go up from the kidneys, and in part of the kidneys. Treatment
includes removing the tumor, allowing the person to keep the bladder.
More invasive cancers require more extensive surgery and follow-up
treatment.
The hope for these urine-screening tests is that they will
save patients from undergoing repeat cystoscopy, which is uncomfortable
and more expensive."
Checking for recurrence
Because even early bladder cancers recur, patients now must undergo
frequent follow-up cystoscopies. The hope for these urine-screening
tests is that they will save patients from undergoing repeat cystoscopy,
which is uncomfortable and more expensive. The problem is that the
new tests are not as accurate. The research is still showing too many
false positives, which is where the test reads positive but there
is no tumor.
Some of these urine tests, such as the NMP22, are already in use for
bladder cancer follow-up. NMP22 was just approved by the U.S. Food
and Drug Administration for use in initial diagnosis. Still, if cancer
is suspected, the physician performs a cystoscopy to know with greater
certainty that cancer is present. In my practice, I rely on flexible
cystoscopy to follow patients and to make the diagnosis.
Use in screening
Much discussion has centered around using the urine tests to screen
the general public for bladder cancer, much like the PSA test is used
to detect prostate cancer or a mammogram is used for breast cancer.
Because bladder cancer is much less common, I think you would have
to limit the screening to people who have symptoms or are at risk
for bladder cancer. So until the specificity and accuracy of these
tests improve, I don't anticipate these urine tests will replace cystoscopy.
Dr. John Colberg is a urologist at Yale-New Haven Hospital and
an assistant professor of surgery and director of uro-oncology at
the Yale University School of Medicine.
|