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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03561350
Enrollment
60
Registered
2018-06-19
Start date
2017-09-28
Completion date
2018-09-30
Last updated
2018-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

Microsatellite Instability, Circulating Tumor DNA, Colorectal Neoplasms

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.

Interventions

None listed

Sponsors

Shanghai Minimally Invasive Surgery Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MSI status in blood samplethrough study completion, an average of 1 yearctDNA 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.

Countries

China

Contacts

Primary ContactZhenghao CAI
czh12005@rjh.com.cn86-21-64458887

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026