Confronting Cancer as a Community
- Conditions
- Colorectal Carcinoma
- Interventions
- Procedure: Archive Sample RetrievalProcedure: Biospecimen CollectionOther: Electronic Health Record ReviewOther: Genetic TestingOther: Questionnaire Administration
- Registration Number
- NCT06063928
- Lead Sponsor
- University of Southern California
- Brief Summary
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
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).
IV. To characterize the gut microbiome through a stool collection kit and nucleic acid extraction process.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
- Inability to understand and the willingness to sign a written informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational (stool, blood, tissue, genetic testing, questionnaires) Electronic Health Record Review Patients undergo stool sample collection, 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. Observational (stool, blood, tissue, genetic testing, questionnaires) Genetic Testing Patients undergo stool sample collection, 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. Observational (stool, blood, tissue, genetic testing, questionnaires) Questionnaire Administration Patients undergo stool sample collection, 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. Observational (stool, blood, tissue, genetic testing, questionnaires) Archive Sample Retrieval Patients undergo stool sample collection, 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. Observational (stool, blood, tissue, genetic testing, questionnaires) Biospecimen Collection Patients undergo stool sample collection, 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.
- Primary Outcome Measures
Name Time Method Overall survival (OS) Assessed up to 6 years Determined from start of treatment until death due to any cause.
Time to recurrence (TTR) Assessed up to 6 years 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.
Progression free survival (PFS) Assessed up to 6 years Determined from start of treatment to time of progression or death (whichever comes first).
Changes in genomic knowledge Baseline, at 2 weeks, and at 12-month follow up The KnowGene scale will be used. Score Range = 0-16. Higher score indicates higher knowledge.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Los Angeles County-USC Medical Center
🇺🇸Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States