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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

Tracking Information
First Submitted Date June 9, 2018
First Posted Date June 20, 2018
Last Update Posted Date May 3, 2019
Actual Study Start Date February 6, 2014
Estimated Primary Completion Date May 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 9, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03563651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collection of Blood, Urine, and Stool to Monitor MetastaticColorectal Cancers
Official Title A Pilot Study of Monitoring Metastatic Colorectal Cancers With Liquid Biopsies
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, urine, stool
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.
Condition
  • 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
Intervention
  • 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
Study Groups/Cohorts 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.
Interventions:
  • Procedure: Biopsy
  • Procedure: Biospecimen Collection
  • Other: Laboratory Biomarker Analysis
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 1, 2019)
29
Original Estimated Enrollment
 (submitted: June 9, 2018)
60
Estimated Study Completion Date February 6, 2021
Estimated Primary Completion Date May 25, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03563651
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party University of Southern California
Study Sponsor University of Southern California
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Afsaneh Barzi, MD University of Southern California
PRS Account University of Southern California
Verification Date May 2019