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

NCT05501353 | Recruiting

• 1 other identifier: 2022-0465
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Metastatic

Keywords

Colorectal Cancer; Colorectal Cancer Metastatic; multi-omics method; biomarker

Outcome Measures

Primary Outcomes (2)

• molecular markers related to prognosis

  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.

  up to 24 months

• the correlation between ctDNA mutations with methylation status and recurrence

  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;

  up to 24 months

Secondary Outcomes (1)

• Compare the difference of DNA with ctDNA in predicting postoperative recurrence through statistical method

  up to 24 months

Study Arms (1)

Group1

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

Other: no intervention

Interventions

no intervention OTHER

This study is an observational study, which does not affect the routine diagnosis and treatment of patients and only requires the collection of biological samples at specific nodes

Group1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with various types of metastatic colorectal cancer who had underwent the radical resection of colorectal cancer and are planning to undergo radical resection of metastasis

You may qualify if:

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

You may not qualify if:

• Currently participating in the intervention study treatment, or receiving other drugs or study devices within 4 weeks before enrollment
• Concurrent with other malignant tumors
• The investigator determined that the patient had other serious diseases that might affect follow-up and short-term survival
• Cardiac function NYHA class III or IV heart disease
• The presence of definite peripheral nerve disease
• There is definite hearing loss

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Guangzhou Burning Rock Dx Co., Ltd.: collaborator
• Guangdong Living Environment Harmless Treatment Center Co., Ltd.: collaborator

Study Sites (1)

the Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

During the study, the investigators collect two blood samples (a total of 7 blood samples, 10ml/sample) and one tissue sample (two cancer tissues and one adjacent cancer tissue, 50mg/sample) of subject

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Lifeng Sun

  2ndAffiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY DIRECTOR

Central Study Contacts

Lifeng Sun

CONTACT

13958103041; sunlifeng@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 15, 2022
• Study Start: July 22, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 8, 2023

Record last verified: 2022-07

Locations

CN (1)