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

NCT ID: NCT05917106

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-26

Study Completion Date

2030-06-30

Brief Summary

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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

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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.

Conditions

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Carcinoma Renal Cell Carcinoma RCC Kidney Neoplasms Kidney Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Le Qu

Associate chief urologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Le Qe, M.D.

Role: CONTACT

15720625951

Facility Contacts

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Le Qu, M.D.

Role: primary

15720625951

Other Identifiers

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2023DZKY-039-01

Identifier Type: -

Identifier Source: org_study_id

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