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Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients

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ClinicalTrials.gov Identifier: NCT03594448
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : August 14, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Study Description
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Brief Summary:
This pilot trial studies how well serial liquid biopsies work in detecting microsatellite instability in participants with stage IV colorectal cancer. Serial liquid biopsies may help doctors learn better methods to track cancer in the bloodstream and how to use these to improve cancer treatments.

Condition or disease Intervention/treatment
Microsatellite Instability Colorectal Cancer Stage IV Procedure: Specimen Collection Procedure: Serial Liquid Biopsy

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Detection of Microsatellite Instability (MSI) in Circulating Tumor DNA of Patients With Stage IV Colorectal Carcinoma
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : September 5, 2024
Estimated Study Completion Date : September 5, 2025
Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients newly diagnosed with stage IV colorectal cancer and with defined microsatellite instability status before initiation of systemic immunotherapy will be recruited.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Severe anemia (hemoglobin [Hb] < 8 g/dL).
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Rabia Rehman 323-865-0460 Rabia.Rehman@med.usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Afsaneh Barzi    323-865-3829    afsaneh.barzi@med.usc.edu   
Principal Investigator: Afsaneh Barzi         
USC Norris Oncology/Hematology-Newport Beach Recruiting
Newport Beach, California, United States, 92663
Contact: Kristy Massopust       Kristy.Massopust@med.usc.edu   
Principal Investigator: Umair Ghani, MD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Heinz Josef Lenz, MD University of Southern California
More Information
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03594448    
Other Study ID Numbers: 3C-18-2
NCI-2018-01169 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
3C-18-2 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Genomic Instability
Colorectal Neoplasms
Microsatellite Instability
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathologic Processes