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Detection of MSI in ctDNA 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 : July 20, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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 Stage IV Colorectal Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 Procedure: Biospecimen 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 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
Estimated Study Start Date : September 10, 2018
Estimated Primary Completion Date : September 10, 2019
Estimated Study Completion Date : September 10, 2020

Group/Cohort Intervention/treatment
Ancillary-correlative (biospecimen 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: Biospecimen Collection
Undergo collection of blood samples

Procedure: Serial Liquid Biopsy
Undergo serial liquid biopsy




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 phyenotypic 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


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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).

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
Contact: Dana Agafitei 323-865-0467 Raluca.Agafitei@med.usc.edu
Contact: Rabia Rehman 323‐865‐0460 Rabia.Rehman@med.usc.edu

Locations
United States, California
USC / Norris Comprehensive Cancer Center Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Afsaneh Barzi    323-865-3829    afsaneh.barzi@med.usc.edu   
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         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Afsaneh Barzi, MD University of Southern California

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03594448     History of Changes
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: July 20, 2018
Last Verified: July 2018

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:
Colorectal Neoplasms
Microsatellite Instability
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Genomic Instability
Pathologic Processes