Collection of Blood, Urine, and Stool to Monitor MetastaticColorectal Cancers

Completed

• Conditions: Stage IV Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8
• Interventions: Procedure: Biopsy; Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

• Registration Number: NCT03563651
• Lead Sponsor: University of Southern California

Brief Summary

This trial studies the monitoring of therapy and progression by collecting blood, urine, and stool from participants with colorectal cancer that has spread to other places in the body or cannot be removed by surgery. Studying samples of blood, urine, and stool from participants with colorectal cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-02-06
• Study First Submitted: 2018-06-09
• Study First Submitted QC: 2018-06-09
• Study First Posted: 2018-06-20
• Primary Completion: 2020-05-28
• Study Completion: 2020-05-28
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (biospecimen collection, biopsy)	Questionnaire Administration	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.
Ancillary-Correlative (biospecimen collection, biopsy)	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.
Ancillary-Correlative (biospecimen collection, biopsy)	Biospecimen Collection	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.
Ancillary-Correlative (biospecimen collection, biopsy)	Laboratory Biomarker Analysis	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.

Primary Outcome Measures

Name	Time	Method
Detection rates of Kras, Braf, or PI3K tumor deoxyribonucleic acid (DNA) extracted from urine in patients with pre-existing mutations	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.
Detection rates of Kras, Braf, or PI3K tumor DNA extracted from urine in patients without pre-existing mutations	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.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States