Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
- Conditions
- Colorectal Neoplasms
- Registration Number
- NCT03561350
- Lead Sponsor
- Shanghai Minimally Invasive Surgery Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MSI status in blood sample 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shanghai Minimally Invasive Surgery Canter, Ruijin hospital
🇨🇳Shanghai, Shanghai, China