Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05002556 |
| Other study ID # |
2021-A01517-34 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
October 30, 2029 |
Study information
| Verified date |
August 2021 |
| Source |
Association Francaise d'Urologie |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The AFU has set itself the task of setting up a register of medical practices in order to
define possible improvements in the therapeutic management and follow-up of NMIBC. In order
to obtain representative data, all urologists who are members of the AFU may be invited to
include their patients in accordance with the rules of clinical research.
Description:
BACKGROUND
Non-muscle infiltrating bladder tumors are a cancerous pathology with an estimated incidence
of 13,000 new cases/year in France. ¾ of new cases are diagnosed at a stage where the cancer
is of limited extension to the urothelial mucosa and/or its underlying chorion
(non-muscle-infiltrating bladder tumors, NIMBT). The management and follow-up of NMITVs are
performed according to the best practice recommendations issued by the Cancer Committee of
the French Urology Association. The risk of recurrence at 1 and 5 years for NMITT has been
estimated in clinical trials to be between 15%-61% and 31%-78%, respectively, depending on
grade, stage, number, size, frequency of previous recurrence and presence of carcinoma in
situ. In this context, patients should have regular endoscopic examinations to ensure the
absence of tumor lesions inside their bladder. Urine cytology pathology is recommended for
the detection of recurrence of NMITV. However, the negative predictive value of this
examination does not allow it to be substituted for bladder endoscopy, as the risk of not
recognizing a bladder tumor, especially of low grade, is too high. To date, no urinary
biomarker has been shown to be clinically useful and their use is not recommended for the
non-invasive detection of endovesical tumor recurrence.
Urine sampling is recommended prior to bladder endoscopy for follow-up of NMITV to ensure
urine sterility (UDEC) and to perform urine cytology in patients with high-grade NMITV and/or
carcinoma in situ.
The observational study of the clinical validity of the negative and positive predictive
values of the biomarkers in a population of patients followed for a bladder tumor previously
characterized is able to demonstrate the possibility of postponing the realization of the
fibroscopy according to the tumoral characteristics and the treatments received by the
patients.
OBJECTIVE
The main objective of the research will be to evaluate the diagnostic performance of
biomarkers available in France, performed on a urine sample and providing a binary result
(positive: probable presence of a tumor recurrence; negative: probable absence of a tumor
recurrence) to the result of the bladder endoscopy performed as part of the routine care for
the follow-up of NMVT: determination of the negative and positive predictive values of
biomarkers.
The secondary objectives will be to describe the anatomopathological characteristics, the
pathological history and the treatments received in the population.
MATERIAL AND METHOD
Before each examination, the participating patients will produce a urine sample of
approximately 20 to 40 ml in total dedicated to the determination of the marker proposed by
your urologist, made by medical analysis laboratory. At each follow-up endoscopic examination
scheduled in the patient's personalized care plan, the investigating urologist will record
its date and endoscopic findings (white light bladder fibroscopy). The name and result of the
urine test will also be recorded by the investigating urologist. The performance of the test
will be evaluated from these data by calculating sensitivity, specificity, positive
predictive value (PPV) and negative predictive value (NPV) and by means of an analysis of
variance (ANOVA) to explore possible differences within the test by tumor grade and stage,
and according to previous endovesical treatments received The inclusion target is 2000
patients in France over a 3-year period.
