Official Title
Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
Brief Title
Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
Protocol ID
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.
Study Period
Enrollment Count
60 participants
Eligibility Criteria
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
Filters
Colorectal Neoplasms
UNKNOWN
ADULT
OLDER_ADULT