Identifying MSI Status From ctDNA in Chinese Patients With Refractory Advanced Solid Tumors

Not Applicable

• Conditions: Solid Tumor
• Interventions: Diagnostic Test: SPANOM (identifying MSI status from ctDNA)

• Registration Number: NCT03596593
• Lead Sponsor: Peking University

Brief Summary

This is a molecular epidemiological investigation aiming to identify microsatellite instability status from circulating tumor DNA in Chinese patients with refractory advanced solid tumors.

Detailed Description

This study is conducted in Chinese patients with advanced refractory metastatic solid tumors. A total of 8-10 mL of blood will be collected from eligible patients and used for extracting circulating tumor DNA. Blood-MSI status will be tested based on SPANOM technique developed by 3D Medicines Inc. Shanghai, China. Patients are encouraged to provide tissues collected from progressive disease for tissue-MSI testing (not required for inclusion).

Study Timeline

• Study First Submitted: 2018-06-27
• Status Verified: 2018-07
• Study Start: 2018-07-11
• Study First Submitted QC: 2018-07-12
• Last Update Submitted: 2018-07-12
• Study First Posted: 2018-07-24
• Last Update Posted: 2018-07-24
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

1. Male or female, age≥18 years old.
2. Confirmed malignant solid tumor by histopathology or cytopathology.
3. Colorectal cancer: progression after second-line therapy. Non-colorectal cancer: progression after first-line therapy.
4. Time duration from the last time of anti-cancer treatment to blood sample collection for MSI testing ≥ two weeks or five times half-life period of anti-cancer drugs
5. Signed the informed consent with name and time.

Exclusion Criteria

1. Hematological malignancy
2. Patients who received immuotherapies.
3. Patients who received blood transfusion within one month before blood collection.
4. Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	SPANOM (identifying MSI status from ctDNA)	A total of 8-10 mL of blood will be collected from this group of patients and used for blood-MSI testing.

Primary Outcome Measures

Name	Time	Method
Incidence of MSI-H across different cancer types in Chinese patients	Two years

Secondary Outcome Measures

Name	Time	Method
Incidence of Lynch syndrome across different cancer types	Two years
Concordance between blood-MSI and corresponding tissue-MSI status	Two years	In patients who are able to provide tumor tissue samples, concordance between blood-MSI status by SPANOM technique and tissue-MSI status by polymerase chain reaction (PCR) method will be calculated.; DNA extracted from each tumor tissue will be amplified by standard PCR using six microsatellite loci: NR-21, BA-26, NR-27, BA-25, NR-24, MONO-27. Tumors are designated MSI-H if more than two loci were instable, MSI-L if one locus is instable, and MSS if all loci are stable.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China