Effect on Xpert® Bladder Test of Urines Inflammatory Milieu Induced by BCG Treatment of Patients With NMIBC

NCT ID: NCT02895620

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-08-31

Brief Summary

Intravesical BCG immunotherapy is used after transurethral resection (TUR) for the prevention of recurrence of NMIBC. BCG treatment is usually started a few weeks after TUR and is given once a week for 6 weeks. It stimulates immune responses that can destroy bladder cancer cells (acute and chronic induced inflammations) and as a consequence causes side effects. The investigators postulate that Xpert® test might be used to demonstrate the presence of residual (after TURB) or recurrent (during adjuvant treatment) disease at the time of intravesical treatment, which could be of very significant impact in the management of this complex situation.Urines of BCG treated patients are rich in immune system elements (cytokines, lymphocytes,…), this complex inflammatory milieu of urines may interfere with urinary biomarkers. This study will allow assessing the effect of the complex inflammatory milieu induced by BCG treatment in urines of patients with NMIBC on the Xpert® Bladder cancer assay.

Detailed Description

1. Qualification of Xpert® Testing:

Three 50 mL fresh urine samples will be collected in sterile containers according to Cepheid instructions of use:

• the "baseline sample" before the first BCG instillation,
• the "study sample" taken during the initiation course of treatment instillations, preferably at the 4th or 5th instillation of BCG therapy,
• the "follow-up sample" at the time of the first follow-up cystoscopy, approximately 3 months after the last BCG instillation of the initiation course.

Xpert® test results will be qualified as positive or negative, according to Cepheid instructions for use.

Samples tested positive at baseline will not be included in the analysis and the patient's participation in the study will be discontinued.

Samples obtained in patients with no recurrence at follow-up cystoscopy after the initiation course will be considered for analysis.

2. Threshold of detection of theXpert® Bladder test:

• One urine sample of a patient tumor free (negative Xpert test) under BCG treatment will be spiked into 3 log dilutions of the 2 distinct tumor cell lines SW780 and BE(2)-C (100, 1000, and 10000 cells per ml).
• A mix of fresh and frozen cells from en bloc harvested tumors from distinct donors will be tested at the set concentration in BCG urines from distinct patients.

Conditions

Non Muscle Invasive Bladder Cancer; Treatment by BCG

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

NMIBC patients Xpert bladder test

Xpert bladder test of urine of patients with NMIBC treated with BCG therapy

Group Type: OTHER

Xpert bladder Test

Intervention Type: BIOLOGICAL

Xpert test positive or negative on urine samples of NMIBC patients treated by BCG

Interventions

Xpert bladder Test

Xpert test positive or negative on urine samples of NMIBC patients treated by BCG

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients presenting with high-risk transitional cell carcinoma of the bladder, according to the EAU guidelines/EORTC risk stratification, who are offered adjuvant BCG instillations.

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cepheid

INDUSTRY

Sponsor Role: collaborator

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut claudius regaud IUCT ONCOPOLE

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philipppe ROCHAIX, MD

Role: CONTACT

rochaix.philippe@iuct-onocpole.fr

531156407 ext. 33

Facility Contacts

philippe ROCHAIX, MD

Role: primary

rochaix.philippe@iuct-oncopole.fr

531156407

Other Identifiers

16HLURO01

Identifier Type: -

Identifier Source: org_study_id