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

September 8, 2016 updated by: Institut Claudius Regaud

Evaluation of the Effect of a Complex Inflammatory Milieu Induced by BCG Treatment in Urines of Patients With Non-muscle-invasive Bladder Cancer on the Xpert® Bladder Cancer Assay

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: NMIBC patients Xpert bladder test
Xpert bladder test of urine of patients with NMIBC treated with BCG therapy
Biological: Xpert bladder Test
Xpert test positive or negative on urine samples of NMIBC patients treated by BCG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of negative Xpert tests results during the initiation course in patients with no recurrence at first follow-up cystoscopy
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Collaborators

Cepheid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16HLURO01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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