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An observational study on the use of circulating tumor DNA for postoperative prognosis assessment and recurrence monitoring in clear cell renal cell carcinoma

An observational study on the use of circulating tumor DNA for postoperative prognosis assessment and recurrence monitoring in clear cell renal cell carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114029
Enrollment
Unknown
Registered
2025-12-05
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Renal tumor

Interventions

Observation group:None

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged =18 years at the time of signing the informed consent form, regardless of gender; 2. ECOG PS score: 0–1; 3. Patients with operable renal cell carcinoma; 4. Clinical stage II–IV according to the AJCC TNM staging system (8th edition); 5. Presence of at least one of the following recurrence risk factors: (1)Tumor stage T2N0M0 with nuclear grade 4 or sarcomatoid features, or tumor stage T3N0M0; (2)Tumor stage T4N0M0, or any T with N1M0; (3)Any T with any N and M1, classified as low-risk per IMDC criteria/Memorial Sloan Kettering Cancer Center (MSKCC) prognostic model, with low metastatic tumor burden, and anticipated complete resection of the primary lesion after neoadjuvant therapy; 6. Normal function of major organs; 7. No prior systemic antitumor therapy, radiotherapy, or other local treatments before enrollment; 8. Able to sign the informed consent form and committed to undergoing diagnosis, treatment, follow-up, and sample collection during the study period.

Exclusion criteria

Exclusion criteria: 1. Patients who are not eligible for surgery; 2. Failure to obtain a definitive pathological result, or pathological findings indicating non-clear cell renal cell carcinoma; 3. History or concurrent diagnosis of other malignancies (except adequately treated carcinoma in situ of the cervix, or basal or squamous cell skin cancer); 4. Inability to provide tissue, blood, or urine samples during the treatment period, or failure to complete the required sample tests due to technical reasons, such as samples not meeting testing requirements, or failure in nucleic acid extraction or quality control; 5. History of blood transfusion within 6 months before enrollment, or prior treatment involving allogeneic organ or stem cell transplantation; 6. Women who are lactating or pregnant; 7. Other conditions deemed unsuitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Methylation levels of biomarkers and ctDNA content in blood and urine cfDNA before surgery and during postoperative monitoring;Survival outcomes;Imaging examination results;

Secondary

MeasureTime frame
Demographic information;Baseline disease characteristics;Oncological characteristics;Perioperative outcomes;

Countries

China

Contacts

Public ContactQingbo Huang

Chinese PLA General Hospital

gdhuangqingbo@163.com+86 139 0427 5683

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026