Hispanic Patient Engagement in Colorectal Cancer Genomics, The ENLACE Trial

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 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:

PHASE I: Patients undergo blood and stool sample collection, collection of archival tumor tissue and genetic testing, and complete surveys on study. Patients also have their medical records reviewed on study. Patients who test positive for a germline mutation may also optionally complete an interview during follow up.

PHASE II: Patients who completed Phase I surveys are randomized to 1 of 2 arms prior to return of genetic testing results.

ARM 1: Patients receive existing educational materials at the time of return of genetic results.

ARM 2: Patients receive a link to an educational video, along with an educational manual at the time of the return of genetic results clinical meeting.

After return of genetic testing results, patients are followed up at 2 weeks, 6 and 12 months, and then annually thereafter.