Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- MSI status in blood sample
Study Overview
Brief Summary
The method to analyze the microsatellite instability (MSI) status by next-generation sequencing (NGS) has been established to assess the deficiency of DNA mismatch repair (MMR) system. The aim of our study is to evaluate the feasibility and reliability of this NGS method by testing the circulating tumor DNA (ctDNA) in blood sample of advanced colorectal cancer patients. If the result is positive, the MSI status could be easily learned without the acquisition of tissue samples.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •a biopsy proven histological diagnosis of colorectal carcinoma
- •MSI status of tissue sample known by IHC or PCR method
- •willing to participate and informed consent signed
Exclusion Criteria
- •history of other malignant tumors
- •patients with inflammatory bowel disease
- •patients with familial adenomatous polyposis
- •patients treated by surgery or adjuvant treatment
- •pregnant or lactating women
Outcomes
Primary Outcomes
MSI status in blood sample
Time Frame: through study completion, an average of 1 year
ctDNA and leucocyte are extracted from blood sample for MSI detection by ColonCore NGS panel (Burning Rock, Guangzhou, China). There are three types of MSI status, MSI-H, MSI-L and MSS.
Secondary Outcomes
No secondary outcomes reported