An observational study in Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8 and Stage IIIB Colorectal Cancer AJCC v8, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-18.
Sponsored by University of Southern California · Observational
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 29 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with metastatic/unresectable colorectal cancer who will undergo first, second, or third line therapy at USC facilities will be recruited for this study.
Inclusion Criteria:
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 · Procedure: Biospecimen Collection · Other: Laboratory Biomarker Analysis · Other: Questionnaire Administration
Undergo biopsy
Also known as: Bx
Undergo collection of blood, urine, and stool
Correlative studies
Ancillary studies
Detection rates of Kras, Braf, or PI3K tumor deoxyribonucleic acid (DNA) extracted from urine in patients with pre-existing mutations
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.
Time frame: Up to 5 years
Detection rates of Kras, Braf, or PI3K tumor DNA extracted from urine in patients without pre-existing mutations
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.
Time frame: Up to 5 years
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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University of Southern California