This is a molecular epidemiological investigation aiming to identify microsatellite instability status from circulating tumor DNA in Chinese patients with refractory advanced solid tumors.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
8,000
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.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGIncidence of MSI-H across different cancer types in Chinese patients
Time frame: Two years
Incidence of Lynch syndrome across different cancer types
Time frame: 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.
Time frame: Two years
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