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

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ClinicalTrials.gov Identifier: NCT03563651
Recruitment Status : Active, not recruiting
First Posted : June 20, 2018
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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 IV Colorectal Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 Procedure: Biopsy Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis Other: Questionnaire Administration

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.


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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study of Monitoring Metastatic Colorectal Cancers With Liquid Biopsies
Actual Study Start Date : February 6, 2014
Estimated Primary Completion Date : May 25, 2020
Estimated Study Completion Date : February 6, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Procedure: Biopsy
Undergo biopsy
Other Name: Bx

Procedure: Biospecimen Collection
Undergo collection of blood, urine, and stool

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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.


Biospecimen Retention:   Samples With DNA
Blood, urine, stool


Information from the National Library of Medicine

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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
Participants with metastatic/unresectable colorectal cancer who will undergo first, second, or third line therapy at USC facilities will be recruited for this study.
Criteria

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

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): NCT03563651


Locations
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United States, California
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Afsaneh Barzi, MD University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03563651     History of Changes
Other Study ID Numbers: 3C-13-2
NCI-2018-00801 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
3C-13-2 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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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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Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases