Explore Biomarkers Associated With Prognosis of Recurrent and Metastatic CRC After Surgery by Multi-omics Methods

Recruiting

• Conditions: Colorectal Cancer Metastatic
• Interventions: Other: no intervention

• Registration Number: NCT05501353
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

This project is the first application, which is applied as a single center project and applied according to the screening quantity. This project is a multi-omics approach to explore biomarkers associated with prognosis after secondary radical resection of recurrent and metastatic colorectal cancer.

Main research objectives: 1. To detect DNA mutation and methylation in tumor tissues by NGS detection technology (the methylation dimension should be detected in adjacent tissues at the same time), and to explore specific molecular markers related to prognosis; 2. Using NGS test technology of blood in patients with preoperative and postoperative blood ctDNA mutations and methylation double dimension testing, respectively, to explore the preoperative and postoperative ctDNA mutations and the correlation between methylation status and recurrence, including but not limited to predict patients with recurrence of sensitivity, specificity, positive predictive value, negative predictive value and recurrence warning time and other indicators.

Main contents: This study intends to include single site for the first time/organ metastasis after radical treatment and surgical indications again in patients with colorectal adenocarcinoma (including but not limited to spread to the liver, lung metastasis, peritoneal metastasis, lymph node metastasis and other organ metastasis), collected in patients with preoperative peripheral blood and tissue samples, tissue adjacent to carcinoma and postoperative peripheral blood, NGS detection technology was used to detect DNA and mutation in the relevant samples, combined with clinical treatment and prognosis information of patients, and then explore biomarkers for predicting recurrence risk.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-22
• Study First Submitted: 2022-07-31
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-15
• Last Update Submitted: 2023-02-05
• Last Update Posted: 2023-02-08
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

1. Colorectal cancer patients with first recurrence and metastasis after previous radical resection
2. Single site/organ metastasis is indicative of reoperation
3. Adenocarcinoma diagnosed by histology or cytology
4. At the time of signing the informed consent, the applicant must be 18 years old or older
5. Life expectancy is at least 12 weeks
6. ECOG score 0~1

Exclusion Criteria

1. Currently participating in the intervention study treatment, or receiving other drugs or study devices within 4 weeks before enrollment
2. Concurrent with other malignant tumors
3. The investigator determined that the patient had other serious diseases that might affect follow-up and short-term survival
4. Cardiac function NYHA class III or IV heart disease
5. The presence of definite peripheral nerve disease
6. There is definite hearing loss
7. Other researchers think it is not suitable for inclusion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1	no intervention	Patients with various types of metastatic colorectal cancer who had underwent the radical resection of colorectal cancer and were planning to undergo radical resection of metastasis

Primary Outcome Measures

Name	Time	Method
molecular markers related to prognosis	up to 24 months	The investigator collect preoperative peripheral blood, surgical tissue samples, adjacent tissues and postoperative peripheral blood from patients. DNA and mutation detection were performed on relevant samples using NGS detection technology and combined with clinical treatment and prognosis information of patients to explore the biomarkers (e.g. CtDNA mutation and ctDNA methylation were combined for MRD detection) of recurrence risk prediction.
the correlation between ctDNA mutations with methylation status and recurrence	up to 24 months	using NGS test technology of blood in patients with preoperative and postoperative blood ctDNA mutations and methylation double dimension testing, respectively, to explore the correlation between the preoperative and postoperative ctDNA mutations with methylation status and recurrence, including but not limited to predict relapse in patients with sensitivity, specificity, positive predictive value, negative predictive value and recurrence warning time and other indicators;

Secondary Outcome Measures

Name	Time	Method
Compare the difference of DNA with ctDNA in predicting postoperative recurrence through statistical method	up to 24 months	To compare the difference in the performance of DNA mutation dimension alone and ctDNA detection (DNA mutation + methylation dual dimension) in predicting postoperative recurrence through statistical method

Trial Locations

Locations (1)

the Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China