Bladder CancerNCT06153849
Analyzing the Urine During BCG Instillation in Bladder Cancer Patients for Disease Followup
An observational study of Bladder Cancer, run by Changhai Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- urine sample collection
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with medianl to high risk NMIBC underwent TURBT and received BCG instillation therapy in Changhai Hospital
Who may be able to join
- Participants aged ≥ 18 years and signed informed consent form.
- Participants diagnosed with median to high risk NMIBC underwent TURBT and received BCG instillation therapy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- urine sample collection
- Keywords
- Bladder cancer, Urine biomarker, Microbiome, Bacillus Calmette-Guérin instillation, Chromosomal instability, Low coverage whole genome sequencing
- Medical subject headings
- Urinary Bladder Neoplasms, Chromosomal Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine sample collectionDiagnostic test
Urine samples from patients receiving BCG instillation was collected for LC-WGS to evaluate CIN and urinary microbiome.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: urine sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between urinary microbiome and BCG instillation efficacy.
Comparison of urinary microbiome between relapsed and non-relapsed patients during follow-up.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Correlation between LOY and prognosis.
Comparison of LOY event frequency between relapse patients and non-relapse patients during follow-up.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuxiong Zeng, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153849
- Sponsor's protocol ID
- CH-LC-WGS-BCGinstillation
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not public for privacy protection purpose. Data without private information may be provided on request.
Publications
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.
PubMed 29297505Krajewski 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.
PubMed 30471076Babjuk 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.
PubMed 34511303Ranjan 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.
PubMed 26718401Han 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.
PubMed 16765182
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing the Urine Microbiome and Chromosomal Instability by Whole Genome Sequening in Bladder Cancer Patients During BCG Instillation for Disease Follow-up
- ClinicalTrials.gov ID
- NCT06153849
- Acronym / sponsor ID
- CH-LC-WGS-BCGinstillation
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, Urine biomarker, Microbiome, Bacillus Calmette-Guérin instillation, Chromosomal instability, Low coverage whole genome sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCG instillation patient | – | Diagnostic Test: urine sample collectionPatients 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with medianl to high risk NMIBC underwent TURBT and received BCG instillation therapy in Changhai Hospital
Key inclusion criteria (2 listed)
- Participants aged ≥ 18 years and signed informed consent form.
- Participants diagnosed with median to high risk NMIBC underwent TURBT and received BCG instillation therapy.
Key exclusion criteria (8 listed)
- Participants with urinary tract infection
- Antibiotic treatment within the last month
- Immuno- /chemo- therapy within the past 6 months
- Immunosuppressive therapy
- Indwelling urinary catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine sample collectionUrine samples from patients receiving BCG instillation was collected for LC-WGS to evaluate CIN and urinary microbiome. | Diagnostic test | BCG instillation patient |
Primary outcome
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.
2 secondary outcomes
Correlation between LOY and prognosis.
Time frame: through study completion, an average of 1 year
Correlation between CIN and tumor relapse
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 29297505Sansregret 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.
- Background: PubMed 30471076Krajewski 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.
- Background: PubMed 34511303Babjuk 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.
- Results publication: PubMed 26718401Ranjan 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.
- Results publication: PubMed 16765182Han 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.
- Individual participant dataSharing planned: No. Individual participant data are not public for privacy protection purpose. Data without private information may be provided on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuxiong Zeng, M.D., Ph.D. (+8618930568759, zengshuxiong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between urinary microbiome and BCG instillation efficacy. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06153849, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.