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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Identifying Microsatellite Instability Status From Circulating Tumor DNA in Chinese Patients With Refractory Advanced Solid Tumors: a Large Molecular Epidemiological Investigation

Conditions
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Solid Tumor

Intervention / Treatment
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* Diagnostic Test: SPANOM (identifying MSI status from ctDNA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age≥18 years old. Confirmed malignant solid tumor by histopathology or cytopathology. Colorectal cancer: progression after second-line therapy. Non-colorectal cancer: progression after first-line therapy. 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 Signed the informed consent with name and time. Exclusion Criteria: Hematological malignancy Patients who received immuotherapies. Patients who received blood transfusion within one month before blood collection. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>A total of 8-10 mL of blood will be collected from this group of patients and used for blood-MSI testing. | Diagnostic Test: SPANOM (identifying MSI status from ctDNA)<br>* SPANOM technique, which has been developed by 3D Medicines Inc. Shanghai, China and made it possible to identify MSI status from blood samples, will be used in patients with refractory advanced solid tumors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of MSI-H across different cancer types in Chinese patients |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Lynch syndrome across different cancer types |  | Two years | 
| Concordance between blood-MSI and corresponding tissue-MSI status | 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. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MSI, Solid tumor, China, ctDNA