Muscle Invasive Upper Tract Urothelial CarcinomaNCT05595408
Circulating and Urine Tumor DNA Dynamics Predict Minimal Residual Disease and Recurrence Risk in Locally Advanced Upper Tract Urothelial Carcinoma
An observational study of Muscle Invasive Upper Tract Urothelial Carcinoma, run by RenJi Hospital at 1 site in China.
Trial summary
In our study, the ultra-deep sequencing of circulating tumor DNA (ctDNA) and urine tumor DNA (utDNA) were performed to assess whether ctDNA and utDNA can be used as predictive biomarkers for the detection of minimal residual disease (MRD) and early diagnosis of UTUC recurrence, and explored the role of ctDNA and utDNA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Upper Tract Urothelial Carcinoma
- What is being tested?
- Adjuvant chemotherapy and adjuvant immunotherapy
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: pathological comfirmed T2-4 or N+ and M0 upper tract urothelial carcinoma patients who received adjuvant chemotherapy or immunotherapy after radical nephroureterectomy
Who may be able to join
- pathological comfirmed T2-4 or N+ and M0 upper tract urothelial carcinoma
- Male or female aged ≥18 years old who are willing to sign the informed consent form
- have no distant metastasis
- have an ECOG 0 to 2
- upper tract urothelial carcinoma patients received radical nephroureterectomy
- have no multiple primary carcinoma
- received adjuvant chemotherapy or immunotherapy after surgery within 12 weeks
- ≥2 postoperative liquid biopsy assessments (T1 and T2)
Who cannot join
- a prior history of bladder or synchronous bladder cancer
- Pregnant or lactating women, or patients who are fertile but do not take contraceptive measures;
- Severe infection;
- Severe heart disease;
- Uncontrollable neurological or mental disorders;
- Severe diabetes mellitus;
Show all 11Show fewer
- Patients with severe autoimmune diseases.
- Neoadjuvant therapy exposure
- No bilateral UTUC
- Surveillance time < month
- <2 postoperative MRD surveillance assessments
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
Renji Hospital
Shanghai, Shanghai Municipality, 200127
jiwei huang, M.D, 8621-68383716, huangjiwei@renji.com
About this study
Official title: Circulating and Urine Tumor DNA Dynamics Predict Minimal Residual Disease and Recurrence Risk in Locally Advanced Upper Tract Urothelial Carcinoma(CURATE-UTUC): A Multicenter Prospective Longitudinal Cohort Study
In our study, the ultra-deep sequencing of circulating tumor DNA (ctDNA) and urine tumor DNA (utDNA) were performed to assess whether ctDNA and utDNA can be used as predictive biomarkers for the detection of minimal residual disease (MRD) and early diagnosis of UTUC recurrence, and explored the role of ctDNA and utDNA detection of MRD in the prediction of adjuvant therapy efficacy and prognostic evaluation.
Read the detailed description
60% of Upper Urinary Tract Urothelial Carcinoma (UTUC) patients with muscle-invasive disease at diagnosis, which progresses rapidly, aggressively, and has a poor prognosis. Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma.
Minimal residual disease (MRD) refers to the small number of malignant cells that remain after curative treatments (curative intent surgical resection, radiotherapy, and/or chemotherapy). MRD is common in patients with blood cancer, and is known to be associated with recurrence and poor prognosis. Recent studies also reported that MRD-negative in postoperative solid tumors such as colorectal/colon cancer and muscle-invasive bladder cancer is associated with better survival outcomes. However, the clinical values of MRD monitoring for adjuvant therapy in postoperative UTUC remain inadequate.
A total of 84 patients with stage II-IV UTUC will be recruited in this clinical trial. The following plasma samples, urine samples and tumor tissues will be collected from each patient including T0 (preoperatively, 2[1-3] days before surgery), T1 (28±3 days postoperatively), T2 (within 7 days after cycle 2 adjuvant therapy), T3 (end-of-treatment), and quarterly/semi-annually during surveillance (T4-T6) until recurrence/24 months. In addition, demographic and tumor characteristics of the patients will be collected for subsequent analysis, including age, sex, tumor stage, pathological stage, disease couse time, etc. Tumor tissues and matched peripheral blood were collected before treatment and WES was used ctDNA detection techniques. For each patient, we selected up to 40 clonal somatic mutations for personalized, tumor informed ctDNA assay design.Statistical analyses will be performed to analyze the survival outcomes and to explore the clinical value of MRD monitoring for adjuvant therapy in postoperative UTUC.
- Being tested
- Adjuvant chemotherapy, adjuvant immunotherapy
- Keywords
- upper tract urothelial carcinoma, Minimal residual disease, Circulating tumor DNA, Urine tumor DNA, adjuvant chemotherapy, adjuvant immunotherapy
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant chemotherapyDrug
cisplatin/carboplatin-gemcitabine 4-6 cycles
adjuvant immunotherapyDrug
immunotherapy for one year
| Study group | Role | What they receive |
|---|---|---|
| adjuvant chemotherapy group | muscle invasive upper tract urothelial carcinoma after radical nephroureterectomy receiving adjuvant chemotherapy Receives: Drug: Adjuvant chemotherapy | |
| adjuvant immunotherapy group | muscle invasive upper tract urothelial carcinoma after radical nephroureterectomy receiving adjuvant immunotherapy Receives: Drug: adjuvant immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
extravesical recurrence free survival
The primary endpoint was extravesical recurrence-free survival (eRFS), defined as the time from radical nephroureterectomy (RNU) to the first occurrence of either locoregional recurrence (e.g., retroperitoneal lymph node, local soft tissue) or distant metastasis, as objectively confirmed by radiological imaging (CT or MRI) according to RECIST 1.1 criteria. Death from any cause without a prior documented extravesical recurrence was considered a competing risk event.
Measured: 2 year
Secondary outcomes (5)
Lead time of molecular recurrence detection
the interval from the first postoperative MRD-positive liquid biopsy to radiologic/cyotscopic
Measured: 2 year
intravesical recurrence free survival
bladder or contralateral upper tract relapse confirmed by cystoscopy/ureteroscopy and biopsy
Measured: 2 year
recurrence-free survival
Defined as the time from RNU to the first occurrence of any recurrence (including both extravesical and intravesical events).
Measured: 2 year
Overall survival
efined as the time from RNU to death from any cause
Measured: 2 year
Diagnostic performance of MRD assay
The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ctDNA (at T1, T2) for predicting extravesical recurrence, and of utDNA (at T2) for predicting intravesical recurrence, against the imaging and cystoscopic gold standards.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Feb 2022
- Primary completion3 Nov 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Upper Tract Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595408
- Sponsor's protocol ID
- CURATE-UTUC
- Status last verified
- Dec 2025
- First submitted
- 22 Oct 2022
- Last updated
- 9 Dec 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating and Urine Tumor DNA Dynamics Predict Minimal Residual Disease and Recurrence Risk in Locally Advanced Upper Tract Urothelial Carcinoma(CURATE-UTUC): A Multicenter Prospective Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT05595408
- Acronym / sponsor ID
- CURATE-UTUC
- Keywords
- upper tract urothelial carcinoma, Minimal residual disease, Circulating tumor DNA, Urine tumor DNA, adjuvant chemotherapy, adjuvant immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Oct 2022 (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.
In our study, the ultra-deep sequencing of circulating tumor DNA (ctDNA) and urine tumor DNA (utDNA) were performed to assess whether ctDNA and utDNA can be used as predictive biomarkers for the detection of minimal residual disease (MRD) and early diagnosis of UTUC recurrence, and explored the role of ctDNA and utDNA detection of MRD in the prediction of adjuvant therapy efficacy and prognostic evaluation.
Detailed description
60% of Upper Urinary Tract Urothelial Carcinoma (UTUC) patients with muscle-invasive disease at diagnosis, which progresses rapidly, aggressively, and has a poor prognosis. Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma.
Minimal residual disease (MRD) refers to the small number of malignant cells that remain after curative treatments (curative intent surgical resection, radiotherapy, and/or chemotherapy). MRD is common in patients with blood cancer, and is known to be associated with recurrence and poor prognosis. Recent studies also reported that MRD-negative in postoperative solid tumors such as colorectal/colon cancer and muscle-invasive bladder cancer is associated with better survival outcomes. However, the clinical values of MRD monitoring for adjuvant therapy in postoperative UTUC remain inadequate.
A total of 84 patients with stage II-IV UTUC will be recruited in this clinical trial. The following plasma samples, urine samples and tumor tissues will be collected from each patient including T0 (preoperatively, 2[1-3] days before surgery), T1 (28±3 days postoperatively), T2 (within 7 days after cycle 2 adjuvant therapy), T3 (end-of-treatment), and quarterly/semi-annually during surveillance (T4-T6) until recurrence/24 months. In addition, demographic and tumor characteristics of the patients will be collected for subsequent analysis, including age, sex, tumor stage, pathological stage, disease couse time, etc. Tumor tissues and matched peripheral blood were collected before treatment and WES was used ctDNA detection techniques. For each patient, we selected up to 40 clonal somatic mutations for personalized, tumor informed ctDNA assay design.Statistical analyses will be performed to analyze the survival outcomes and to explore the clinical value of MRD monitoring for adjuvant therapy in postoperative UTUC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adjuvant chemotherapy group | – | Drug: Adjuvant chemotherapymuscle invasive upper tract urothelial carcinoma after radical nephroureterectomy receiving adjuvant chemotherapy |
| adjuvant immunotherapy group | – | Drug: adjuvant immunotherapymuscle invasive upper tract urothelial carcinoma after radical nephroureterectomy receiving adjuvant immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pathological comfirmed T2-4 or N+ and M0 upper tract urothelial carcinoma patients who received adjuvant chemotherapy or immunotherapy after radical nephroureterectomy
Key inclusion criteria (8 listed)
- pathological comfirmed T2-4 or N+ and M0 upper tract urothelial carcinoma
- Male or female aged ≥18 years old who are willing to sign the informed consent form
- have no distant metastasis
- have an ECOG 0 to 2
- upper tract urothelial carcinoma patients received radical nephroureterectomy
Key exclusion criteria (11 listed)
- a prior history of bladder or synchronous bladder cancer
- Pregnant or lactating women, or patients who are fertile but do not take contraceptive measures;
- Severe infection;
- Severe heart disease;
- Uncontrollable neurological or mental disorders;
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 |
|---|---|---|
| Adjuvant chemotherapycisplatin/carboplatin-gemcitabine 4-6 cycles | Drug | adjuvant chemotherapy group |
| adjuvant immunotherapyimmunotherapy for one year | Drug | adjuvant immunotherapy group |
Primary outcome
extravesical recurrence free survival
Time frame: 2 year
The primary endpoint was extravesical recurrence-free survival (eRFS), defined as the time from radical nephroureterectomy (RNU) to the first occurrence of either locoregional recurrence (e.g., retroperitoneal lymph node, local soft tissue) or distant metastasis, as objectively confirmed by radiological imaging (CT or MRI) according to RECIST 1.1 criteria. Death from any cause without a prior documented extravesical recurrence was considered a competing risk event.
5 secondary outcomes
Lead time of molecular recurrence detection
Time frame: 2 year
intravesical recurrence free survival
Time frame: 2 year
recurrence-free survival
Time frame: 2 year
Overall survival
Time frame: 2 year
Diagnostic performance of MRD assay
Time frame: 2 year
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 9 Dec 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 Muscle Invasive Upper Tract Urothelial Carcinoma, run by RenJi 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 8 inclusion and 11 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 9 Dec 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 jiwei huang, M.D (8613651682825, huangjiwei@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
extravesical recurrence free survival (time frame: 2 year). 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 9 Dec 2025.