Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Southern California
With
National Cancer Institute (NCI)
PRIMARY OBJECTIVES:
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.
OUTLINE:
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients newly diagnosed with stage IV colorectal cancer and with defined microsatellite instability status before initiation of systemic immunotherapy.
Trackable cancer-driver mutation in the primary tumor documented before initiation of chemotherapy.
Zubrod performance status of 0 or 1.
Patients have measurable disease according to RECIST version (v)1.1.
Ability to understand and willing to sign a written informed consent.
You may not be if
Severe anemia (hemoglobin \[Hb\] \< 8 g/dL).
Clareo Health | Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients