Confronting Cancer as a Community

Colorectal Carcinoma Clinical Trial

Official title: Confronting Cancer as a Community

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

• NCT number: NCT06063928
• Study type: Observational
• Source: University of Southern California
• Contact: Ashley Noriega
• Phone: 323-865-3000
• Email: Ashley.Noriega@med.usc.edu
• Status: Recruiting
• Start date: May 25, 2022
• Completion date: May 25, 2028