Confronting Cancer as a Community

University of Southern California

Status: Enrolling

Conditions: Colorectal Carcinoma

Treatments: Other: Intervention Educational Materials; Other: Usual Care Educational Materials

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06063928

U2CCA252971 (U.S. NIH Grant/Contract)

3C-21-3 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

NCI-2022-10775 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• 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

• Inability to understand and the willingness to sign a written informed consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Arm 1: Usual Care

Experimental group

Description:

Patients will receive standard educational materials prior to the return of their results to better understand the results.

Treatment:

Other: Usual Care Educational Materials

Arm 2: Intervention

Experimental group

Description:

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.

Treatment:

Other: Intervention Educational Materials