Urinary Cell-Free DNA Test for Urothelial Cancer Origin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, observational study enrolling about 477 adults: 159 with upper tract urothelial cancer, 159 with bladder cancer, and 159 without cancer. Participants provide a midstream urine sample that is processed at a central lab to extract cell-free DNA, with usual medical care continuing as usual. No experimental drugs or devices are given to participants. The goal is to see whether urine DNA patterns can distinguish cancer presence and origin non-invasively. The study will correlate urine test results with standard clinical and pathological data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Where it's running

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Danfeng Xu
• Email: hh12295@rjh.com.cn
• Phone: 18817875498

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Adding targeted stereotactic body radiation therapy to standard systemic treatment for people with oligometastatic urothelial (bladder) carcinoma.

  This study will test whether adding stereotactic body radiation therapy (SBRT) to usual systemic treatment helps people with urothelial (bladder) cancer who have up to three extracranial metastases.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.