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

NCT02895620 | Unknown

• 1 other identifier: 16HLURO01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Muscle Invasive Bladder Cancer; Treatment by BCG

Outcome Measures

Primary Outcomes (1)

• Rate of negative Xpert tests results during the initiation course in patients with no recurrence at first follow-up cystoscopy

  12 months

Secondary Outcomes (1)

• rate of Xpert tests found positive in samples with predefined tumour cell concentrations ( limit of detection) in inflammatory milieu of urines induced by the BCG treatment in patients with bladder cancer

  12 months

Study Arms (1)

NMIBC patients Xpert bladder test

OTHER

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

Biological: Xpert bladder Test

Interventions

Xpert bladder Test BIOLOGICAL

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

NMIBC patients Xpert bladder test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• Cepheid: collaborator

Study Sites (1)

Institut claudius regaud IUCT ONCOPOLE

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Philipppe ROCHAIX, MD

CONTACT

531156407; rochaix.philippe@iuct-onocpole.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 9, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 9, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)