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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917106
• Other study ID #: 2023DZKY-039-01
• Status: Recruiting
• Start date: December 26, 2022
• Est. completion date: June 2030

Study information

• Verified date: June 2023
• Source: Jinling Hospital, China
• Contact: Le Qe, M.D.
• Phone: 15720625951
• Email: septsoul[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 2030
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To explore the predictive effect of ctDNA methylomics on the prognosis and medication guidance of renal carcinoma.		5 years
Primary	To explore the advance time of ctDNA methylomics in monitoring postoperative recurrence of renal cancer compared with imaging.		5 years
Primary	The molecular mechanism of renal cancer recurrence was analyzed with baseline tissue and circulating methylation profiles.		5 years
Primary	A renal cancer recurrence risk model was established based on clinical information, molecular risk factors and ctDNA methylomics		5 years