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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05917106
Enrollment
450
Registered
2023-06-23
Start date
2022-12-26
Completion date
2030-06-30
Last updated
2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Kidney Cancer, Kidney Neoplasms, RCC, Renal Cell Carcinoma

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.

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.

Interventions

None listed

Sponsors

Jinling Hospital, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 methylomics5 years

Countries

China

Contacts

Primary ContactLe Qe, M.D.
septsoul@hotmail.com15720625951

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026