Actively Recruiting
Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)
Led by Jinling Hospital, China · Updated on 2025-12-11
450
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective study to evaluate the value of circulating tumor DNA (ctDNA) and its abnormal methylation in monitoring patients undergoing kidney cancer surgery. Kidney cancer releases the lowest amount of ctDNA among non-brain tumors, and the detection of tumor mutations is often less than 50% even in advanced stages. This study focuses on analyzing ctDNA methylation changes, which have not been previously explored in renal cancer monitoring, to improve understanding and follow-up of this disease. The study will analyze the dynamic changes in ctDNA and its methylation status from before surgery through long-term follow-up in patients with kidney cancer. It will compare the usefulness of ctDNA methylation detection with traditional imaging and blood tumor marker tests during monitoring. The study aims to build models predicting recurrence risk based on molecular and clinical data. Participants will be followed for five years, with researchers assessing the predictive power of ctDNA methylomics for prognosis and medication guidance, as well as the timing of recurrence detection compared to imaging. Tissue and circulating methylation profiles will be analyzed to understand the molecular mechanisms behind cancer recurrence. The study will involve regular follow-up visits and tests according to protocol to monitor health and disease status over the long term.
CONDITIONS
Brief Title
Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed renal cell carcinoma
- No prior treatment for kidney cancer
- Agree to undergo radical surgical treatment
- Signed informed consent
- ECOG performance status of 0 or 1
- Willing to follow study protocol and procedures
You will not qualify if you...
- History of other cancers
- Prior antitumor therapy
- Known or suspected active autoimmune disease
- Unable to provide informed consent due to medical or psychiatric conditions
- Uncontrolled heart-related symptoms or diseases
- Deemed unsuitable for study participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week before surgery
Participants undergo baseline assessments including collection of tissue and blood samples to analyze circulating tumor DNA (ctDNA) methylation status before surgery.
1 visit (in-person)
Duration - Up to 2 weeks
Participants receive radical surgical treatment for renal cell carcinoma and immediate post-surgical care.
1 to 2 visits (in-person)
Duration - Up to 5 years
Participants are followed up to monitor dynamic changes in ctDNA methylation and compare these with traditional imaging and blood tumor markers to detect cancer recurrence.
Periodic visits for sample collection and imaging assessments (visit frequency per protocol)
Trial Site Locations
Total: 1 location
1
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
L
Le Qe, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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