Bladder Cancer Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | May 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital |
China,
Babjuk M, Burger M, Capoun O, Cohen D, Comperat EM, Dominguez Escrig JL, Gontero P, Liedberg F, Masson-Lecomte A, Mostafid AH, Palou J, van Rhijn BWG, Roupret M, Shariat SF, Seisen T, Soukup V, Sylvester RJ. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022 Jan;81(1):75-94. doi: 10.1016/j.eururo.2021.08.010. Epub 2021 Sep 10. — View Citation
Han RF, Pan JG. Can intravesical bacillus Calmette-Guerin reduce recurrence in patients with superficial bladder cancer? A meta-analysis of randomized trials. Urology. 2006 Jun;67(6):1216-23. doi: 10.1016/j.urology.2005.12.014. — View Citation
Krajewski W, Zdrojowy R, Grzegolka J, Krajewski P, Wrobel M, Luczak M, Kolodziej A. Does Mantoux Test Result Predicts BCG Immunotherapy Efficiency and Severe Toxicity in Non-Muscle Invasive Bladder Cancer. Urol J. 2019 Oct 21;16(5):458-462. doi: 10.22037/uj.v0i0.4542. — View Citation
Ranjan R, Rani A, Metwally A, McGee HS, Perkins DL. Analysis of the microbiome: Advantages of whole genome shotgun versus 16S amplicon sequencing. Biochem Biophys Res Commun. 2016 Jan 22;469(4):967-77. doi: 10.1016/j.bbrc.2015.12.083. Epub 2015 Dec 22. — View Citation
Sansregret L, Vanhaesebroeck B, Swanton C. Determinants and clinical implications of chromosomal instability in cancer. Nat Rev Clin Oncol. 2018 Mar;15(3):139-150. doi: 10.1038/nrclinonc.2017.198. Epub 2018 Jan 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between urinary microbiome and BCG instillation efficacy. | Comparison of urinary microbiome between relapsed and non-relapsed patients during follow-up. | through study completion, an average of 1 year | |
Secondary | Correlation between LOY and prognosis. | Comparison of LOY event frequency between relapse patients and non-relapse patients during follow-up. | through study completion, an average of 1 year | |
Secondary | Correlation between CIN and tumor relapse | 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 |
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