Collection of Blood, Urine, and Stool to Monitor MetastaticColorectal Cancers
A Pilot Study of Monitoring Metastatic Colorectal Cancers With Liquid Biopsies
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients with metastatic/unresectable colorectal cancer who will undergo first, second, or third line therapy; the participating investigator will select treatment, however, patients with Kras wild type must receive anti-EGFR therapy to be eligible for this study
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
|
Correlative studies
Ancillary studies
Undergo biopsy
Other Names:
Undergo collection of blood, urine, and stool
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection rates of Kras, Braf, or PI3K tumor deoxyribonucleic acid (DNA) extracted from urine in patients with pre-existing mutations
Time Frame: Up to 5 years
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Mutation detection rate will be estimated by gene and treatment cycle in each cohort.
The quantities of mutated Kras, Braf, or PI3K will be estimated using means and standard deviation if the distribution of the quantities is compatible with normal distribution.
Otherwise, medians, ranges and interquartiles will be used.
The changes in the mutation status and quantities of Kras, Braf, and PI3K before and after starting the first line therapy will be estimated using contingency tables and plots.
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Up to 5 years
|
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Detection rates of Kras, Braf, or PI3K tumor DNA extracted from urine in patients without pre-existing mutations
Time Frame: Up to 5 years
|
Mutation detection rate will be estimated by gene and treatment cycle in each cohort.
The quantities of mutated Kras, Braf, or PI3K will be estimated using means and standard deviation if the distribution of the quantities is compatible with normal distribution.
Otherwise, medians, ranges and interquartiles will be used.
The changes in the mutation status and quantities of Kras, Braf, and PI3K before and after starting the first line therapy will be estimated using contingency tables and plots.
|
Up to 5 years
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3C-13-2 (Other Identifier: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2018-00801 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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