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ID05917106

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

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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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Surgery and Immediate Post-operative Care

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)

Long-term Monitoring

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

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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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