Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)
1 other identifier
observational
450
1 country
1
Brief Summary
To conduct prospective studies to confirm the value of circulating tumor DNA and its abnormal methylation in longitudinal monitoring of patients undergoing kidney cancer surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 26, 2022
CompletedFirst Submitted
Initial submission to the registry
June 9, 2023
CompletedFirst Posted
Study publicly available on registry
June 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
December 11, 2025
December 1, 2025
5.4 years
June 9, 2023
December 4, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
To explore the predictive effect of ctDNA methylomics on the prognosis and medication guidance of renal carcinoma.
5 years
To explore the advance time of ctDNA methylomics in monitoring postoperative recurrence of renal cancer compared with imaging.
5 years
The molecular mechanism of renal cancer recurrence was analyzed with baseline tissue and circulating methylation profiles.
5 years
A renal cancer recurrence risk model was established based on clinical information, molecular risk factors and ctDNA methylomics
5 years
Eligibility Criteria
RCC patients undergoing surgical treatment
You may qualify if:
- Newly diagnosed renal cell carcinoma
- Without any treatment
- Agree and accept radical surgical treatment
- Signed written informed consent
- ECOG(Eastern Cooperative Oncology Group) performance is 0 or 1
- Follow up protocol and related procedures
You may not qualify if:
- Had other cancers
- Had received any antitumor therapy before
- Known or suspected active autoimmune disease
- Informed consent is not possible due to medical or psychiatric problems
- Have clinical symptoms or diseases of the heart that are not well controlled
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Nanjing, Jiangsu, 210000, China
Biospecimen
Fresh tumor tissue and blood samplesare collected from each patient.Blood collection time: P0: within 7 days before surgery P1:3-7 days after surgery PF1:1 month postoperatively PF2: 4months postoperatively PF3:sequentially 3 months apart PA1: Before postoperative adjuvant therapy PA2: During postoperative adjuvant therapy PA3: After postoperative adjuvant therapy PA4:sequentially spaced 3 months PR: detection when recurrence
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate chief urologist
Study Record Dates
First Submitted
June 9, 2023
First Posted
June 23, 2023
Study Start
December 26, 2022
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2030
Last Updated
December 11, 2025
Record last verified: 2025-12