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

NCT ID: NCT03561350

Last Updated: 2018-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-28

Study Completion Date

2018-09-30

Brief Summary

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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

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Conditions

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Colorectal Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Minimally Invasive Surgery Canter, Ruijin hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhenghao CAI

Role: CONTACT

86-21-64458887

Facility Contacts

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Zhenghai CAI, MD

Role: primary

Other Identifiers

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MISC-MSI

Identifier Type: -

Identifier Source: org_study_id

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