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Trial Title:
Explore Biomarkers Associated With Prognosis of Recurrent and Metastatic CRC After Surgery by Multi-omics Methods
NCT ID:
NCT05501353
Condition:
Colorectal Cancer Metastatic
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal Cancer
Colorectal Cancer Metastatic
multi-omics method
biomarker
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
no intervention
Description:
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
Arm group label:
Group1
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the Second Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Lifeng Sun
Phone:
139 5810 3041
Email:
sunlifeng@zju.edu.cn
Start date:
July 22, 2022
Completion date:
September 1, 2027
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Guangzhou Burning Rock Dx Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Guangdong Living Environment Harmless Treatment Center Co., Ltd.
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05501353
