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Trial Title:
Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)
NCT ID:
NCT05917106
Condition:
Carcinoma
Renal Cell Carcinoma
RCC
Kidney Neoplasms
Kidney Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
RCC patients undergoing surgical treatment
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Le Qu, M.D.
Phone:
15720625951
Email:
septsoul@hotmail.com
Start date:
December 26, 2022
Completion date:
June 2030
Lead sponsor:
Agency:
Jinling Hospital, China
Agency class:
Other
Source:
Jinling Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05917106
