Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients
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|ClinicalTrials.gov Identifier: NCT03594448|
Recruitment Status : Not yet recruiting
First Posted : July 20, 2018
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment|
|Microsatellite Instability Colorectal Cancer Stage IV||Procedure: Specimen Collection Procedure: Serial Liquid Biopsy|
I. To test the hypothesis that there is high level of concordance between the electrophoretic mobility profile of microsatellite biomarkers in circulating cell-free deoxyribonucleic acid (ccfDNA) versus in primary tumor tissues in patients with colorectal carcinomas displaying microsatellite instability.
II. To test the hypothesis that changes in the electrophoretic mobility profile of microsatellite biomarkers in liquid biopsies from patients with colorectal carcinoma correlate with therapeutic responsiveness measured based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
III. To determine whether microsatellite alleles generated as a result of microsatellite instability detectable in liquid biopsy specimens from patients with colorectal carcinoma represent the entire cancer cell population or only a subset of cancer cells differentially affected by genomic instability.
Participants undergo collection of blood samples to evaluate microsatellite instability via serial liquid biopsies at baseline, then every 6 weeks and at progression or 9 months.
|Study Type :||Observational|
|Estimated Enrollment :||35 participants|
|Official Title:||Detection of Microsatellite Instability (MSI) in Circulating Tumor DNA of Patients With Stage IV Colorectal Carcinoma|
|Estimated Study Start Date :||October 22, 2018|
|Estimated Primary Completion Date :||October 22, 2019|
|Estimated Study Completion Date :||October 22, 2020|
Ancillary-correlative (Specimen collection)
Participants undergo collection of blood samples in addition to the usual amount collected when they come in for their regular cancer treatments or doctor?s appointment every 6-8 weeks until disease progression or stopping at 9 months.
Procedure: Specimen Collection
Undergo collection of blood samples
Procedure: Serial Liquid Biopsy
Undergo serial liquid biopsy
- Correlation between presence of MSI present in circulating tumor DNA versus in primary tumor specimens [ Time Frame: Up to 1 year ]MSI testing distinguishes between tumors into one of 3 phenotypic categories: MSI-High (MSI-H) is reported when > 30% of biomarkers show instability; Microsatellite stable (MSS) is reported in the absence of instability. The third category, MSI-Low (MSI-L) is diagnostically equivalent to MSS, and is reported when MSI is present in < 30% of biomarkers. MSI status will be determined by polymerase chain reaction (PCR) using commercial kits provided by Promega.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594448
|Contact: Dana Agafitei||323-865-0467||Raluca.Agafitei@med.usc.edu|
|Contact: Rabia Rehman||323‐865‐0460||Rabia.Rehman@med.usc.edu|
|United States, California|
|USC / Norris Comprehensive Cancer Center||Not yet recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Afsaneh Barzi 323-865-3829 firstname.lastname@example.org|
|Principal Investigator: Afsaneh Barzi|
|Hoag Memorial Hospital||Not yet recruiting|
|Newport Beach, California, United States, 92663|
|Contact: Diana L. Hanna 949-764-6130 Diana.Hanna@med.usc.edu|
|Principal Investigator: Diana L. Hanna|
|Principal Investigator:||Afsaneh Barzi, MD||University of Southern California|