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

Phase

N/A

Condition

Renal Cell Cancer

Cancer/tumors

Renal Cell Carcinoma

Treatment

N/A

Clinical Study ID

NCT05917106

2023DZKY-039-01

All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

December 26, 2022

June 30, 2030

Study 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.

Connect with a study center

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Nanjing, Jiangsu 210000
China
Active - Recruiting

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