Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Carcinoma, Renal Cell Carcinoma, RCC, Kidney Neoplasms. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Some studies have shown the potential of ctDNA in renal cancer monitoring, but the amount of ctDNA released in renal cancer is the lowest among non-cranial tumors. Even in advanced patients, the detection rate of tumor system mutation is less than 50%. DNA methylation is important in the process of tumor occurrence and development. However, no studies have focused on the value of ctDNA methylation in monitoring renal cancer, nor have large prospective cohort studies been conducted in patients with renal cancer.
This study intended to analyze the dynamic changes of circulating tumor DNA and its methylation status in patients with kidney cancer from preoperative to long-term follow-up, and to compare the evaluation value of methylation detection with traditional imaging examination and traditional blood tumor markers in the monitoring process.
Primary outcome measures
- To explore the predictive effect of ctDNA methylomics on the prognosis and medication guidance of renal carcinoma. [Time frame: 5 years]
- To explore the advance time of ctDNA methylomics in monitoring postoperative recurrence of renal cancer compared with imaging. [Time frame: 5 years]
- The molecular mechanism of renal cancer recurrence was analyzed with baseline tissue and circulating methylation profiles. [Time frame: 5 years]
- A renal cancer recurrence risk model was established based on clinical information, molecular risk factors and ctDNA methylomics [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Patients judged by the investigators to be unsuitable for inclusion in this study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Chin — Nanjing
Identifiers
NCT: NCT05917106 · 2023DZKY-039-01