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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03561350
• Other study ID #: MISC-MSI
• Status: Recruiting
• Start date: September 28, 2017
• Est. completion date: September 2018

Study information

• Verified date: May 2018
• Source: Shanghai Minimally Invasive Surgery Center
• Contact: Zhenghao CAI
• Phone: 86-21-64458887
• Email: czh12005[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Microsatellite Instability

Locations

Country	Name	City	State
China	Shanghai Minimally Invasive Surgery Canter, Ruijin hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Minimally Invasive Surgery Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year