Clinical trial NCT05917106: Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)
Official title: Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma
Renal Cell Carcinoma
RCC
Kidney Neoplasms
Kidney Cancer
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RCC patients undergoing surgical treatment

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.

Eligibility criteria: 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

Primary outcomes:
measure: To explore the predictive effect of ctDNA methylomics on the prognosis and medication guidance of renal carcinoma.
timeFrame: 5 years
measure: To explore the advance time of ctDNA methylomics in monitoring postoperative recurrence of renal cancer compared with imaging.
timeFrame: 5 years
measure: The molecular mechanism of renal cancer recurrence was analyzed with baseline tissue and circulating methylation profiles.
timeFrame: 5 years
measure: A renal cancer recurrence risk model was established based on clinical information, molecular risk factors and ctDNA methylomics
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
state: Jiangsu
Study officials:
References: