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NCT Number: NCT05917106

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Nanjing, Jiangsu, 210000, China

Location status: Recruiting

Location contact

Le Qu, M.D.

CONTACT

[email protected]

15720625951

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 5 years

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

    Time frame: 5 years

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

    Time frame: 5 years

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

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Le Qe, M.D.

CONTACT

[email protected]

15720625951

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2030
First posted
Jun 23, 2023
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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