Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing

Shanghai Minimally Invasive Surgery Center60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal Neoplasms

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Minimally Invasive Surgery Canter, Ruijin hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

MSI status in blood sample

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.

Time frame: through study completion, an average of 1 year

Central Contacts

Zhenghao CAI

CONTACT

86-21-64458887 czh12005@rjh.com.cn

Data from ClinicalTrials.gov

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