NMIBCNCT06991868
A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD)
An observational study of NMIBC and MIBC, run by Peking University First Hospital at 1 site in China.
Trial summary
This was a multicenter, prospective, non-interventional, observational cohort study, and the enrolled patients were divided into four cohorts: cohort I was patients with high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+); cohort II was patients with non-muscle invasive bladder cancer (NMIBC) (including… Read more about this study
- Who is it for?
- Ages 18 months and older
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+), non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk/very-high-risk), and muscle-invasive bladder cancer (MIBC)
Who may be able to join
- patients ≥18 years of age with full civil capacity at the time of signing the informed consent form;
- patients who provide a urine sample for MRD testing at the time of undergoing postoperative review;
- Pathologic type: required to be a pathologically confirmed uroepithelial tumor with a predominantly urothelial tumor with a primary site in the upper urinary tract (including the renal pelvis and ureters), and permitted to contain no more than 50% squamous differentiation, adenomatous differentiation, or sarcomatoid differentiation and are pT3/4 or any TpN+.
- patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;
- patients who provided a urine sample for central testing when they underwent postoperative review;
- Pathological type: a pathologically confirmed predominantly uroepithelial tumor with a primary site in the bladder is required, and is permitted to contain no more than 50% squamous differentiation, or adenoidal differentiation carcinoma in situ is permitted to be present or only in situ and the pathologic stage may be T1, Ta, or Tis (Cis)
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- patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;
- patients providing urine samples for centralized testing prior to each cycle of treatment during neoadjuvant therapy;
- pathology type: a predominantly uroepithelial tumor with a TUR surgical pathology primary site in the bladder is required, and is permitted to contain no more than 50% squamous, adenomatous, or sarcomatoid differentiation (iii) Patients with pathologic stage T2 or MIBC on comprehensive imaging despite pathologic stage T1;
- Radical cystectomy after neoadjuvant therapy, including bladder, prostate, and seminal vesicles in men and bladder and uterus in women;
- lymph node dissection at least to the extent of the standard dissection for bladder cancer (including the area of the common iliac arteries below the bifurcation of the iliac arteries bilaterally and the area between the ipsoas and genitofemoral nerve to the ureter);
- the presence of evaluable lesions on imaging based on RECIST 1.1 criteria prior to neoadjuvant therapy.
- patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;
- patients to provide a urine sample for centralized testing at each review visit;
- pathology type: the TUR surgical pathology is required to be a predominantly urothelial tumor with a primary site in the bladder, and is allowed to contain no more than 50% squamous, adenomatous, or sarcomatous differentiation;
- there should be a centralized imaging to assess a clinical assessment of MIBC prior to TMT treatment;
- patients assessed as clinically CR after undergoing TMT who can continue to retain their bladder and do not require salvage cystotomy.
Who cannot join
- Pathology after radical surgery that does not meet the criteria for enrollment;
- Predictable inability to meet the criteria for regular review at our center within 1 year postoperatively;
- Disagreement with regular cystoscopy and/or imaging (at least completion of one of CT or MR or PET/CT, with intervals between reviews as well as the specific items to be determined by the clinician);
- Already definite recurrence or metastasis;
- Concomitant combination of other active malignant neoplastic disease or a history of other malignant neoplastic disease within 5 years (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment)
- Cohort II:
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- TUR pathology that does not meet the enrollment criteria;
- predictable inability to meet the regular review at our center within 1 year postoperatively;
- disagreement with regular cystoscopy and/or imaging (the content and type of imaging will be determined by the clinician);
- definite recurrence or metastasis already exists;
- concurrent combination of other active malignant neoplastic disease or a 5-year history of other malignant neoplastic disease history (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment)
- Cohort III:
- TUR pathology that does not meet enrollment criteria;
- does not undergo radical total cystectomy or standard surgical scope;
- receives less than 2 cycles of neoadjuvant therapy;
- does not undergo regular imaging evaluations during preoperative neoadjuvant therapy;
- has no evaluable lesions prior to neoadjuvant therapy;
- already has definitively present distant metastases;
- concurrently combines other active malignant neoplastic disease or a history of other malignant neoplastic disease within 5 years (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment).
- Cohort IV:
- TUR pathology that does not meet the inclusion criteria;
- predictable inability to meet the regular review at our center within 1 year after surgery;
- no pre-treatment imaging at our center;
- disagreement with regularity of receiving imaging (the clinician decides on the content and type of imaging);
- residual lesions or metastases that are already clearly present;
- concurrent combination of other active malignant neoplastic diseases or a history of other malignant neoplastic diseases within 5 year history of other malignant neoplastic disease (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
18811562117, 2211210227@pku.edu.cn
About this study
This was a multicenter, prospective, non-interventional, observational cohort study, and the enrolled patients were divided into four cohorts: cohort I was patients with high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+); cohort II was patients with non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk/very-high-risk); cohort III was patients with muscle-invasive bladder cancer (MIBC) to receive neoadjuvant therapy; and cohort IV was patients evaluated for complete response (CR) after standard trimodality therapy (TMT) treatment (i.e. patients with successful bladder preservation). Primary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence/metastasis; Cohort II: MRD score to assess the sensitivity and specificity of tumor recurrence; Cohort III: MRD score to assess the sensitivity and specificity of tumor remnants. Secondary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence subgroup and metastasis subgroup; Cohort II: MRD score to assess the sensitivity and specificity of different grades and stages of recurrent tumors; Cohort III: MRD scores to assess the sensitivity and specificity of different grades and stages of residual tumors.
- Keywords
- high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+), non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk/very-high-risk), muscle-invasive bladder cancer (MIBC)
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort I | 1. patients ≥18 years of age with full civil capacity at the time of signing the informed consent form; 2. patients who provide a urine sample for MRD testing at the time of undergoing postoperative review; 3. Pathologic type: required to be a pathologically confirmed uroepithelial tumor with a predominantly urothelial tumor with a primary site in the upper urinary tract (including the renal pelvis and ureters), and permitted to contain no more than 50% squamous differentiation, adenomatous differentiation, or sarcomatoid differentiation and are pT3/4 or any TpN+. | |
| Cohort II | 1. patients aged ≥18 years at the time of signing the informed consent form with full civil capacity; 2. patients who provided a urine sample for central testing when they underwent postoperative review; 3. Pathological type: a pathologically confirmed predominantly uroepithelial tumor with a primary site in the bladder is required, and is permitted to contain no more than 50% squamous differentiation, or adenoidal differentiation carcinoma in situ is permitted to be present or only in situ and the pathologic stage may be T1, Ta, or Tis (Cis). | |
| Cohort III | 1. patients aged ≥18 years at the time of signing the informed consent form with full civil capacity; 2. patients providing urine samples for centralized testing prior to each cycle of treatment during neoadjuvant therapy; 3. pathology type: a predominantly urothelial tumor with a TUR surgical pathology primary site in the bladder is required, and is permitted to contain no more than 50% squamous, adenomatous, or sarcomatoid differentiation (iii) Patients with pathologic stage T2 or MIBC on comprehensive imaging despite pathologic stage T1; 4. Radical cystectomy after neoadjuvant therapy, including bladder, prostate, and seminal vesicles in men and bladder and uterus in women; 5. lymph node dissection at least to the extent of the standard dissection for bladder cancer (including the area of the common iliac arteries below the bifurcation of the iliac arteries bilaterally and the area between the ipsoas and genitofemoral nerve to the ureter) | |
| Cohort IV | 1. patients aged ≥18 years at the time of signing the informed consent form with full civil capacity; 2. patients to provide a urine sample for centralized testing at each review visit; 3. pathology type: the TUR surgical pathology is required to be a predominantly uroepithelial tumor with a primary site in the bladder, and is allowed to contain no more than 50% squamous, adenomatous, or sarcomatous differentiation; 4. there should be a centralized imaging to assess a clinical assessment of MIBC prior to TMT treatment; 5. patients assessed as clinically CR after undergoing TMT who can continue to retain their bladder and do not require salvage cystotomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
UC MRD score
Provide 100 ml of morning urine for UC MRD testing at the appropriate collection node; assessment results were recorded as a score (0-100)
Measured: Cohort I: At begin of Cycle 1 and end of Cycle 6 (each cycle 21 days); Cohort II: every 6 months after surgery until 12 months; Cohort III: Baseline and The first day of thest neoadjuvant ther Cohort IV: every 6 months after TMT therapy until 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Mar 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMIBCStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991868
- Sponsor's protocol ID
- UCMRD-010
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD)
- ClinicalTrials.gov ID
- NCT06991868
- Acronym / sponsor ID
- UCMRD-010
- Keywords
- high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+), non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk/very-high-risk), muscle-invasive bladder cancer (MIBC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 28 May 2025 (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.
This was a multicenter, prospective, non-interventional, observational cohort study, and the enrolled patients were divided into four cohorts: cohort I was patients with high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+); cohort II was patients with non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk/very-high-risk); cohort III was patients with muscle-invasive bladder cancer (MIBC) to receive neoadjuvant therapy; and cohort IV was patients evaluated for complete response (CR) after standard trimodality therapy (TMT) treatment (i.e. patients with successful bladder preservation). Primary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence/metastasis; Cohort II: MRD score to assess the sensitivity and specificity of tumor recurrence; Cohort III: MRD score to assess the sensitivity and specificity of tumor remnants. Secondary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence subgroup and metastasis subgroup; Cohort II: MRD score to assess the sensitivity and specificity of different grades and stages of recurrent tumors; Cohort III: MRD scores to assess the sensitivity and specificity of different grades and stages of residual tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort I | – | –1. patients ≥18 years of age with full civil capacity at the time of signing the informed consent form; 2. patients who provide a urine sample for MRD testing at the time of undergoing postoperative review; 3. Pathologic type: required to be a pathologically confirmed uroepithelial tumor with a predominantly urothelial tumor with a primary site in the upper urinary tract (including the renal pelvis and ureters), and permitted to contain no more than 50% squamous differentiation, adenomatous differentiation, or sarcomatoid differentiation and are pT3/4 or any TpN+. |
| Cohort II | – | –1. patients aged ≥18 years at the time of signing the informed consent form with full civil capacity; 2. patients who provided a urine sample for central testing when they underwent postoperative review; 3. Pathological type: a pathologically confirmed predominantly uroepithelial tumor with a primary site in the bladder is required, and is permitted to contain no more than 50% squamous differentiation, or adenoidal differentiation carcinoma in situ is permitted to be present or only in situ and the pathologic stage may be T1, Ta, or Tis (Cis). |
| Cohort III | – | –1. patients aged ≥18 years at the time of signing the informed consent form with full civil capacity; 2. patients providing urine samples for centralized testing prior to each cycle of treatment during neoadjuvant therapy; 3. pathology type: a predominantly urothelial tumor with a TUR surgical pathology primary site in the bladder is required, and is permitted to contain no more than 50% squamous, adenomatous, or sarcomatoid differentiation (iii) Patients with pathologic stage T2 or MIBC on comprehensive imaging despite pathologic stage T1; 4. Radical cystectomy after neoadjuvant therapy, including bladder, prostate, and seminal vesicles in men and bladder and uterus in women; 5. lymph node dissection at least to the extent of the standard dissection for bladder cancer (including the area of the common iliac arteries below the bifurcation of the iliac arteries bilaterally and the area between the ipsoas and genitofemoral nerve to the ureter) |
| Cohort IV | – | –1. patients aged ≥18 years at the time of signing the informed consent form with full civil capacity; 2. patients to provide a urine sample for centralized testing at each review visit; 3. pathology type: the TUR surgical pathology is required to be a predominantly uroepithelial tumor with a primary site in the bladder, and is allowed to contain no more than 50% squamous, adenomatous, or sarcomatous differentiation; 4. there should be a centralized imaging to assess a clinical assessment of MIBC prior to TMT treatment; 5. patients assessed as clinically CR after undergoing TMT who can continue to retain their bladder and do not require salvage cystotomy. |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+), non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk/very-high-risk), and muscle-invasive bladder cancer (MIBC)
Key inclusion criteria (17 listed)
- patients ≥18 years of age with full civil capacity at the time of signing the informed consent form;
- patients who provide a urine sample for MRD testing at the time of undergoing postoperative review;
- Pathologic type: required to be a pathologically confirmed uroepithelial tumor with a predominantly urothelial tumor with a primary site in the upper urinary tract (including the renal pelvis and ureters), and permitted to contain no more than 50% squamous differentiation, adenomatous differentiation, or sarcomatoid differentiation and are pT3/4 or any TpN+.
- patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;
- patients who provided a urine sample for central testing when they underwent postoperative review;
Key exclusion criteria (26 listed)
- Pathology after radical surgery that does not meet the criteria for enrollment;
- Predictable inability to meet the criteria for regular review at our center within 1 year postoperatively;
- Disagreement with regular cystoscopy and/or imaging (at least completion of one of CT or MR or PET/CT, with intervals between reviews as well as the specific items to be determined by the clinician);
- Already definite recurrence or metastasis;
- Concomitant combination of other active malignant neoplastic disease or a history of other malignant neoplastic disease within 5 years (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
UC MRD score
Time frame: Cohort I: At begin of Cycle 1 and end of Cycle 6 (each cycle 21 days); Cohort II: every 6 months after surgery until 12 months; Cohort III: Baseline and The first day of thest neoadjuvant ther Cohort IV: every 6 months after TMT therapy until 12 months
Provide 100 ml of morning urine for UC MRD testing at the appropriate collection node; assessment results were recorded as a score (0-100)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
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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.
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 NMIBC and MIBC, run by Peking University First 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 17 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 28 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cuijian Zhang, MD. (+86 18511695818, surgeon_zhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UC MRD score (time frame: Cohort I: At begin of Cycle 1 and end of Cycle 6 (each cycle 21 days); Cohort II: every 6 months after surgery until 12 months; Cohort III: Baseline and The first day of thest neoadjuvant ther Cohort IV: every 6 months after TMT therapy until 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2025.