Official Title
Identifying Microsatellite Instability Status From Circulating Tumor DNA in Chinese Patients With Refractory Advanced Solid Tumors: a Large Molecular Epidemiological Investigation
Brief Title
Identifying MSI Status From ctDNA in Chinese Patients With Refractory Advanced Solid Tumors
Protocol ID
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 Period
Enrollment Count
8,000 participants
Eligibility Criteria
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.
Filters
Solid Tumor
NA
UNKNOWN
ADULT
OLDER_ADULT