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

Colorectal Cancer Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05501353
• Other study ID #: 2022-0465
• Status: Recruiting
• Start date: July 22, 2022
• Est. completion date: September 1, 2027

Study information

• Verified date: July 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Lifeng Sun
• Phone: 13958103041
• Email: sunlifeng[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Other:
• no intervention
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

Locations

Country	Name	City	State
China	the Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Guangdong Living Environment Harmless Treatment Center Co., Ltd., Guangzhou Burning Rock Dx Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Compare the difference of DNA with ctDNA in predicting postoperative recurrence through statistical method	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	up to 24 months