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

NCT06153849 | Unknown

• 1 other identifier: CH-LC-WGS-BCGinstillation
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

Bladder cancer; Urine biomarker; Microbiome; Bacillus Calmette-Guérin instillation; Chromosomal instability; Low coverage whole genome sequencing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation between LOY and prognosis.

  through study completion, an average of 1 year

• Correlation between CIN and tumor relapse

  through study completion, an average of 1 year

Study Arms (1)

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

Interventions

urine sample collection DIAGNOSTIC_TEST

Urine samples from patients receiving BCG instillation was collected for LC-WGS to evaluate CIN and urinary microbiome.

BCG instillation patient

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (5)

• 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.

  PMID: 29297505 BACKGROUND

• 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.

  PMID: 30471076 BACKGROUND

• 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.

  PMID: 34511303 BACKGROUND

• 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.

  PMID: 26718401 RESULT

• 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.

  PMID: 16765182 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples were collected form bladder cancer patient and DNA was extracted from urine sediment.

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Chromosomal Instability

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genomic Instability

Central Study Contacts

Shuxiong Zeng, M.D., Ph.D.

CONTACT

+8618930568759; zengshuxiong@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 1, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)