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Development and Validation of a Urinary cfDNA Fragmentomics Assay for Early Detection of Urologic Tumors

Development and Validation of a Urinary cfDNA Fragmentomics Assay for Early Detection of Urologic Tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122669
Enrollment
Unknown
Registered
2026-04-16
Start date
2026-04-16
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genitourinary Tumors (Bladder Cancer, Kidney Cancer, Prostate Cancer)

Interventions

Urinary Tumor Group:None
Non-cancer Control Group:None

Sponsors

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Urological Tumor Subjects 1. Age over 18 years and under 80 years, no gender restriction. 2. Histologically and/or cytologically diagnosed with urothelial carcinoma, renal cell carcinoma, or prostate cancer. 3. Comprehensive clinical and pathological information is obtainable. 4. Subjects have read and fully understood the patient information sheet and signed the informed consent form. Translated with DeepL.com (free version); Non-Cancer Control Population Inclusion Criteria 1. Age over 45 years old and under 80 years old, no gender restriction; 2. No evidence of any tumors or suspicious nodules identified through systematic examination; 3. Subjects determined to be healthy through systematic examination, with no other major chronic diseases including cardiovascular and cerebrovascular diseases, chronic respiratory diseases, diabetes, stage III hypertension, acute or subacute severe hepatitis, etc.; 4. The subject has read and fully understood the patient information sheet and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Female subjects who are pregnant or currently breastfeeding; 2. Subjects with a current diagnosis of tumors other than urinary tract tumors, or with a history of prior tumors; 3. Subjects who have received any form of tumor treatment prior to enrollment, including surgery, radiotherapy/chemotherapy, targeted therapy, or immunotherapy; 4. Organ transplant recipients or individuals who have previously undergone non-autologous (allogeneic) bone marrow or stem cell transplantation; 5. Individuals with febrile illnesses, or those requiring medical treatment for acute episodes or inflammatory diseases within 14 days prior to enrollment; 6. Any other clinically significant disease or condition deemed by the investigator to potentially affect protocol compliance, compromise the patient's ability to provide informed consent, or render the patient unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Area Under the ROC Curve (AUC);Specificity;Sensitivity;

Countries

China

Contacts

Public ContactJiahua Pan

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

jiahua.pan@outlook.com+86 21 1234567

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026