Analyzing the Urine During BCG Instillation in Bladder Cancer Patients for Disease Followup

November 30, 2023 updated by: Shuxiong Zeng, Changhai Hospital

Analyzing the Urine Microbiome and Chromosomal Instability by Whole Genome Sequening in Bladder Cancer Patients During BCG Instillation for Disease Follow-up

Bacillus Calmette-Guerin (BCG) has been extensively utilized in intravesical instillation therapy for patients with medium to high risk non-muscle invasive bladder cancer (NMIBC) following transurethral resection of bladder tumor (TURBT). Nevertheless, the efficacy of BCG instillation can fluctuate between patients, with 40.5% experiencing disease recurrence during BCG therapy. The effectiveness of BCG instillation may be linked to the urinary microbiome and immune microenvironment. Additionally, small residual lesions post-TURBT could also result in bladder cancer recurrence. Low coverage whole genome sequencing (LC-WGS) can be used to detect the urinary microbiome and chromosomal instability (CIN), making it feasible to predict the recurrence or progression of bladder cancer during BCG instillation therapy. Here, we intend to evaluate the feasibility of detecting urine samples of bladder cancer patients receiving BCG instillation to predict the bladder cancer recurrence.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

NMIBC at medium to high risk showcases a recurrence rate of 40.5% post-TURBT, thus necessitating frequent monitoring and bladder instillation. Among patients with medium to high-risk NMIBC, the preferred treatment is BCG. The high recurrence rate of this illness is associated with BCG's effectiveness and residual cancer, yet the full understanding of BCG installation's mechanism complicates the prediction of its efficacy among individuals with bladder cancer.

Previously, it was believed that the urinary system was sterile; however, recent high-throughput sequencing and enhanced quantitative urine culture have confirmed the presence of resident bacteria in the urine of healthy individuals. Microorganisms within the bladder have the potential to alter the immune microenvironment, consequently impacting the efficacy of BCG instillation.

CIN denotes continuous errors in chromosome separation during cell division, encompassing numerical and structural instability. Loss of the Y chromosome (LOY) represents a specific type of CIN associated with cancer prognosis. CIN serves as a hallmark of malignancies and can be employed to indicate the presence of minimal residual disease (MRD) subsequent to TURBT. Analyzing LOY can better elucidate the disease's progression, and more exploration is necessary to comprehend the significance of detecting CIN for predicting tumor recurrence.

LC-WGS is a cost-effective, efficient, and robust technique that can be used to analyze both microorganism and human genomes in urine samples. The microbiome is commonly detected using 16S ribosomal sequencing. Compared to 16S sequencing, LC-WGS provides advantages such as enhanced detection of bacterial species, diversity, and improved gene prediction. In the context of CIN and LOY detection, LC-WGS technology offers heightened sensitivity, low cost, and high throughput compared to traditional methods such as comparative genomic hybridization or fluorescence in situ hybridization.

In this prospective, single-arm observational clinical trial, the investigators aim to evaluate LOY, CIN, and the urinary microbiome detected by LC-WGS for the assessment of BCG instillation efficacy and NMIBC follow-up.

Study Type

Observational

Enrollment (Estimated)

100

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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with medianl to high risk NMIBC underwent TURBT and received BCG instillation therapy in Changhai Hospital

Description

Inclusion Criteria:

  • Participants aged ≥ 18 years and signed informed consent form.
  • Participants diagnosed with median to high risk NMIBC underwent TURBT and received BCG instillation therapy.

Exclusion Criteria:

  • Participants with urinary tract infection
  • Antibiotic treatment within the last month
  • Immuno- /chemo- therapy within the past 6 months
  • Immunosuppressive therapy
  • Indwelling urinary catheter
  • Additional major diagnosis known to affect the gut or bladder microbiota (e. g. liver cirrhosis, systemic sclerosis, inflammatory bowel disease, inflammatory bowel syndrome, celiac disease, neuropathic bladder)
  • Participants with urothelial carcinoma accompanied by other malignancy.
  • Individuals unwilling to sign the consent form or unwilling to provide urine sample for test or quality of urine sample is poor.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BCG instillation patient
Patients with pathology-confirmed median to high risk urothelial carcinoma defined by 2023 EAU guideline, underwent transurethral resection of bladder tumor and receiving BCG instillation therapy.
Diagnostic test: urine sample collection
Urine samples from patients receiving BCG instillation was collected for LC-WGS to evaluate CIN and urinary microbiome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between urinary microbiome and BCG instillation efficacy.
Time Frame: through study completion, an average of 1 year
Comparison of urinary microbiome between relapsed and non-relapsed patients during follow-up.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between LOY and prognosis.
Time Frame: through study completion, an average of 1 year
Comparison of LOY event frequency between relapse patients and non-relapse patients during follow-up.
through study completion, an average of 1 year
Correlation between CIN and tumor relapse
Time Frame: through study completion, an average of 1 year
Comparison of MRD reflected by CIN level in urine samples between relapsed and non-relapsed patients during follow-up.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Estimated)

December 1, 2023

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-LC-WGS-BCGinstillation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are not public for privacy protection purpose. Data without private information may be provided on request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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