Hispanic Patient Engagement in Colorectal Cancer Genomics, COPECC Study

Study Overview
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Brief Summary
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This study aims to better understand the cause of colorectal cancer and how to find the best treatment for Hispanic patients with colorectal cancer. The genetic information in the blood and tissues may explain why patients who have the same type of cancer and receive the same treatment do not always have the same results. By combining genetic (certain qualities or traits passed from parents to offspring) information with clinical data, such as the responses of different kinds of cancers to different treatments, this study could lead to more knowledge about why certain cancers occur and why they respond differently to treatments. Information gathered from this study may help researchers match treatments to the genetics of each patient and the genetic changes in their tumor. This approach is known as personalized medicine.

Detailed Description
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PRIMARY OBJECTIVE: I. To create a well-characterized cohort of Hispanic patients with colon cancer, with patient-level data, genomic, transcriptomic, clinical, and outcomes data. SECONDARY OBJECTIVES: I. To identify genomic/transcriptomic predictors of treatment outcomes (time to recurrence, time to progression, and overall survival). II. To identify associations between somatic tumor deoxyribonucleic acid (DNA) methylation patterns and clinical outcomes. III. To examine patterns of patient engagement in genetic/genomic testing among Hispanic patients with colorectal cancer (CRC). EXPLORATORY OBJECTIVES: I. To validate, characterize and discover molecular processes in the CRC tumor common to other CRC populations and specific to Hispanic patients. II. To determine whether comorbidities are associated with variation in tumor molecular pathways and whether comorbidities are effect modifiers of associations between tumor molecular variation and disease outcomes and response to treatment in Hispanic CRC patients. OUTLINE: This is an observational study. Patients undergo blood sample collection, collection of archival tumor tissue and genetic testing, and complete questionnaires on study. Patients also have their medical records reviewed on study. After return of genetic testing results, patients are followed up at 2 weeks, 12 months, and then annually thereafter.

Official Title
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University of Southern California (USC) Center for Optimization of Participant Engagement for Cancer Characterization (COPECC)

Conditions
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Colorectal Carcinoma

Intervention / Treatment
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* Procedure: Archive Sample Retrieval
* Procedure: Biospecimen Collection
* Other: Electronic Health Record Review
* Other: Genetic Testing
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported Hispanic ethnicity Diagnosed with colon or rectal cancer (at any time and stage; lifetime diagnosis and in survival are eligible) Has a tumor tissue sample archived or plans to have tissue archived from a standard care procedure Age >= 18 years Exclusion Criteria: Inability to understand and the willingness to sign a written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (blood, tissue, genetic testing, questionnaires)<br>Patients undergo blood sample collection, collection of archival tumor tissue and genetic testing, and complete questionnaires on study. Patients also have their medical records reviewed on study. | Procedure: Archive Sample Retrieval<br>* Undergo collection of archival tumor tissue<br>* Other names: ARCHIVE RETRIEVING;Procedure: Biospecimen Collection<br>* Undergo blood sample collection<br>* Other names: Specimen Collection;Other: Electronic Health Record Review<br>* Medical records reviewed<br>Other: Genetic Testing<br>* Undergo genetic testing<br>* Other names: Genetic Test;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence (TTR) | Determined from time of registration to date of documented event such as treatment-related deaths, second same or other primary cancers, and deaths from other cancers. | Assessed up to 6 years | 
| Progression free survival (PFS) | Determined from start of treatment to time of progression or death (whichever comes first). | Assessed up to 6 years | 
| Overall survival (OS) | Determined from start of treatment until death due to any cause. | Assessed up to 6 years | 
| Changes in genomic knowledge | The KnowGene scale will be used. Score Range = 0-16. Higher score indicates higher knowledge. | Baseline, at 2 weeks, and at 12-month follow up |