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

Sponsor
Jinling Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05917106
Collaborator
(none)
450
Enrollment
1
Location
89.2
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    450 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)
    Actual Study Start Date :
    Dec 26, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2028
    Anticipated Study Completion Date :
    Jun 1, 2030

    Outcome Measures

    Primary Outcome Measures

    1. To explore the predictive effect of ctDNA methylomics on the prognosis and medication guidance of renal carcinoma. [5 years]

    2. To explore the advance time of ctDNA methylomics in monitoring postoperative recurrence of renal cancer compared with imaging. [5 years]

    3. The molecular mechanism of renal cancer recurrence was analyzed with baseline tissue and circulating methylation profiles. [5 years]

    4. A renal cancer recurrence risk model was established based on clinical information, molecular risk factors and ctDNA methylomics [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China Nanjing Jiangsu China 210000

    Sponsors and Collaborators

    • Jinling Hospital, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qu Le, Associate chief urologist, Jinling Hospital, China
    ClinicalTrials.gov Identifier:
    NCT05917106
    Other Study ID Numbers:
    • 2023DZKY-039-01
    First Posted:
    Jun 23, 2023
    Last Update Posted:
    Jul 3, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell
    Kidney Neoplasms

    Study Results

    No Results Posted as of Jul 3, 2023