Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2022-05-25
2028-05-25
Brief Summary
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Detailed Description
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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).
IV. To compare two strategies for providing education to patients before receiving genetic results.
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.
III. To perform microbiome sequencing through a stool collection kit and nucleic acid extraction to understand the interplay between gut microbiome and cancer progression and response to therapy.
IV. Conduct in-depth analysis of the gut microbiome in the context of genomic characterization and clinical variables.
V. Evaluate the impact of conducting genetic and tumor testing among colorectal cancer patients in the clinic.
VI. Evaluate associations between lifestyle, dietary, and social determinants of health and clinical outcomes and tumor characteristics.
VII. Identify potential reasons why some participants decline to participate in this study.
VIII. Increase understanding of family communication of germline test results.
IX. Explore the barriers to and facilitators of cascade testing among participants who have a germline pathogenic variant.
OUTLINE: This is an interventional 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. Patients are randomized into one of two arms before they receive their test results -- Arm 1: Usual Care and Arm 2: Intervention.
After return of genetic testing results, patients are followed up at 2 weeks, 6 months (one blood draw), 12 months, and then annually thereafter.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm 1: Usual Care
Patients will receive standard educational materials prior to the return of their results to better understand the results.
Usual Care Educational Materials
Standard education materials
Arm 2: Intervention
Patients will receive CoGenes educational materials and video prior to the return of their results to better understand the results. The goal is to provide education about the benefits of genetic and tumor testing and to increase the patient's knowledge.
Intervention Educational Materials
CoGenes educational materials with video.
Interventions
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Usual Care Educational Materials
Standard education materials
Intervention Educational Materials
CoGenes educational materials with video.
Eligibility Criteria
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Inclusion Criteria
* 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
* Ability to understand and the willingness to sign a written informed consent.
* For those who would like to participate in the optional microbiome characterization aspect of the study, the patient will have to be under 40 years old at any clinical cancer stage or over 60 years old at any clinical cancer stage.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Heinz-Josef Lenz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2022-10775
Identifier Type: REGISTRY
Identifier Source: secondary_id
3C-21-3
Identifier Type: OTHER
Identifier Source: secondary_id
3C-21-3
Identifier Type: -
Identifier Source: org_study_id
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