Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)

Jinling Hospital, China

Status: Enrolling

Conditions: Kidney Cancer; Kidney Neoplasms; Carcinoma; RCC; Renal Cell Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT05917106

2023DZKY-039-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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