Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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.

Undergo collection of archival tumor tissue

Archive Sample Retrieval

Undergo stool and blood sample collection

Biospecimen Collection

Electronic Health Record Review

Genetic Testing

Questionnaire Administration

Ashley Noriega

Heinz-Josef Lenz, MD

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.

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.

Confronting Cancer as a Community

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.

Determined from start of treatment to time of progression or death (whichever comes first).

Determined from start of treatment until death due to any cause.

The KnowGene scale will be used. Score Range = 0-16. Higher score indicates higher knowledge.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Confronting Cancer as a Community	NCT06063928	Colorectal Carc...	Archive Sample ... Biospecimen Col... Electronic Heal... Genetic Testing Questionnaire A...	18 Years -	University of Southern California
Confronting Cancer as a Community	NCT06063928	Colorectal Carc...	Archive Sample ... Biospecimen Col... Electronic Heal... Genetic Testing Questionnaire A...	18 Years -	University of Southern California

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