Urothelial Carcinoma (UC)NCT07888374
Urinary Cell-Free DNA Liquid Biopsy for Urothelial Cancer Diagnosis and Origin Identification
An observational study of Urothelial Carcinoma (UC) and Upper Tract Urothelial Carcinoma, run by Ruijin Hospital at 1 site in China.
Trial summary
Urothelial carcinoma is the most common cancer of the urinary system. It includes bladder cancer and upper urinary tract cancer, which starts in the kidney pelvis or ureter. Doctors currently tell these types apart mainly by using invasive tests such as cystoscopy or ureteroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma (UC), Upper Tract Urothelial Carcinoma, Bladder Cancer
- How many people
- 477 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2026to 30 Jun 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
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
- Adult, Older adult
Study population: Adults aged 18 years or older with hematuria who are undergoing clinical evaluation for urothelial carcinoma at participating centers. After enrollment and urine sample collection, participants are classified into three groups based on histopathological or clinical results: upper tract urothelial carcinoma, bladder cancer, and non-cancer controls. The study plans to enroll 477 participants, including 159 with upper tract urothelial carcinoma, 159 with bladder cancer, and 159 non-cancer controls. The population is recruited prospectively and consecutively from urology outpatient and inpatient settings at the participating centers.
Who may be able to join
- Age ≥18 years at the time of enrollment. Participants must have hematuria and be undergoing evaluation for urothelial carcinoma.
- Cases: Histopathologically confirmed primary urothelial carcinoma of the bladder, renal pelvis, or ureter, with no prior anti-tumor treatment, including transurethral surgery, radical surgery, systemic or local chemotherapy, radiotherapy, or immunotherapy.
- Controls: No tumor or suspected space-occupying lesion confirmed by systematic examination, including urinary ultrasound or computed tomography.
- Complete clinical and pathological data available, including tumor location, stage, and grade for cases.
- Willingness to provide urine samples. Written informed consent obtained.
Who cannot join
- History of malignant tumors at other sites. Blood transfusion within 7 days before urine sampling. History of organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Any severe systemic disease, acute infection, or other condition that, in the investigator's judgment, may affect sample quality or study participation.
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
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Danfeng Xu, 18817875498, hh12295@rjh.com.cn
About this study
Official title: Multimodal Liquid Biopsy for the Diagnosis and Origin Identification of Urothelial Carcinoma: A Prospective, Multicenter, Observational Study
Urothelial carcinoma is the most common cancer of the urinary system. It includes bladder cancer and upper urinary tract cancer, which starts in the kidney pelvis or ureter. Doctors currently tell these types apart mainly by using invasive tests such as cystoscopy or ureteroscopy. These tests can be uncomfortable and may miss some tumors. This study is testing whether a urine sample can offer a simpler, non-invasive way to detect urothelial cancer and identify where the cancer started.
This is a prospective, multicenter, observational study. It plans to enroll 477 adults, including 159 patients with upper urinary tract urothelial cancer, 159 patients with bladder cancer, and 159 people without cancer. Participants will provide a midstream urine sample of about 30 mL using a special collection tube. No experimental drug or device will be given. Participants will receive their usual medical care.
The urine samples will be sent to a central laboratory. Researchers will extract cell-free DNA, which are small pieces of DNA released by cells into the urine. They will then perform low-pass whole-genome sequencing and study DNA fragment patterns, called fragmentomics. Machine learning will be used to build models that may help detect urothelial cancer and distinguish upper urinary tract cancer from bladder cancer. The study will also explore whether these urine DNA patterns are related to tumor stage and grade. The results may help develop a convenient urine-based test for patients in the future.
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary 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 |
|---|---|---|
| Upper Tract Urothelial Carcinoma Cohort | Participants with histopathologically confirmed primary upper tract urothelial carcinoma, including renal pelvis and ureteral carcinoma, who have not received any prior anti-tumor treatment, including transurethral surgery, radical surgery, systemic or local chemotherapy, radiotherapy, or immunotherapy. | |
| Bladder Cancer Cohort | Participants with histopathologically confirmed primary bladder urothelial carcinoma who have not received any prior anti-tumor treatment, including transurethral surgery, radical surgery, systemic or local chemotherapy, radiotherapy, or immunotherapy. | |
| Non-Cancer Control Cohort | Participants without any tumor or suspected space-occupying lesion confirmed by systematic examination, including urinary ultrasound or computed tomography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic Curve for Differentiating Upper Tract Urothelial Carcinoma from Lower Tract Urothelial Carcinoma
The primary outcome is the area under the receiver operating characteristic curve (AUC) of the urinary cell-free DNA (cfDNA) fragmentomics-based model for differentiating upper tract urothelial carcinoma (UTUC) from lower tract urothelial carcinoma (bladder cancer) in the independent validation set. The model will be constructed using multimodal fragmentomic features extracted from low-pass whole-genome sequencing data, including fragment size distribution, end motif preference, nucleosome positioning, genome coverage fluctuation, and copy number alteration signals. Machine learning algorithms including logistic regression, random forest, support vector machine, and ensemble learning models will be applied. The AUC will be calculated with its 95% confidence interval, and sensitivity, specificity, positive predictive value, and negative predictive value will also be reported.
Measured: After completion of sample collection and analysis, anticipated within 12 months of study start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start5 Apr 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma (UC)Studies of the same condition, open and under way.
- More trials run by Ruijin 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 477 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888374
- Sponsor's protocol ID
- 2026-708
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No