Collection of Blood, Urine, and Stool to Monitor MetastaticColorectal Cancers
NCT ID: NCT03563651
Last Updated: 2021-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
29 participants
OBSERVATIONAL
2014-02-06
2020-05-28
Brief Summary
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Detailed Description
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I. Detection of mutated Kras in urine specimen of patients with Kras mutated metastatic colon cancer on first, second, or third line therapy.
II. Detection of new Kras in urine in patients without Kras mutated metastatic colon cancer on therapy which includes anti-EGFR antibodies (cetuximab or panitumumab).
SECONDARY OBJECTIVES:
I. Changes of the stool microbiome with chemotherapy and at progression of the disease.
DESCRIPTIVE OBJECTIVES:
I. Changes in the quantity of mutated Kras, Braf or PI3K in urine deoxyribonucleic acid (DNA) over the cycles of first line therapy.
II. Associations between the quantity of mutated Kras, Braf or PI3K in urine DNA, molecular make up of circulating tumor cells (CTCs), cell free DNA and progression over the course of first line therapy.
III. Feasibility of detection of exosome in the plasma of colorectal cancer patients on first line chemotherapy in Dr. Fabbri?s lab at Children?s Hospital Los Angeles.
IV. Feasibility of detection of tumor DNA in the plasma of colorectal cancer patients on first line chemotherapy.
OUTLINE:
Participants undergo collection of blood and urine at baseline, on day 1 of courses 1, 2, and 3, at restaging, and at disease progression. Participants may undergo collection of stool at baseline, on day 1 of course 2, and at disease progression. Participants also undergo biopsy within 4 weeks of disease progression.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Ancillary-Correlative (biospecimen collection, biopsy)
Participants undergo collection of blood and urine at baseline, on day 1 of courses 1, 2, and 3, at restaging, and at disease progression. Participants may undergo collection of stool at baseline, on day 1 of course 2, and at disease progression. Participants also undergo biopsy within 4 weeks of disease progression.
Biopsy
Undergo biopsy
Biospecimen Collection
Undergo collection of blood, urine, and stool
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Interventions
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Biopsy
Undergo biopsy
Biospecimen Collection
Undergo collection of blood, urine, and stool
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject consent to enrollment on the protocol
* Histologically confirmed metastatic or un-resectable colorectal cancer, known Kras status; knowledge of other mutations is optional
* Willingness to undergo biopsy at the time of progression
* Willingness to follow the study instructions for collection of specimens
* Available archival tissue
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Afsaneh Barzi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2018-00801
Identifier Type: REGISTRY
Identifier Source: secondary_id
3C-13-2
Identifier Type: OTHER
Identifier Source: secondary_id
3C-13-2
Identifier Type: -
Identifier Source: org_study_id