An observational study in Urothelial Carcinoma (UC), Upper Tract Urothelial Carcinoma and Bladder Cancer, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Ruijin Hospital · Observational
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.
725 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.
This study's planned enrollment of 477 is above the median of 200 across 125 observational studies indexed under Carcinoma, Transitional Cell.
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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.
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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.
Exclusion Criteria:
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.
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.
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.
Participants without any tumor or suspected space-occupying lesion confirmed by systematic examination, including urinary ultrasound or computed tomography.
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.
Time frame: After completion of sample collection and analysis, anticipated within 12 months of study start.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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