Confronting Cancer as a Community

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Carcinoma
• Intervention / Treatment: Other: Usual Care Educational Materials; Other: Intervention Educational Materials

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley Noriega; Phone Number: 323-865-3000; Email: Ashley.Noriega@med.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC / Norris Comprehensive Cancer Center
      • Principal Investigator: Heinz-Josef Lenz, MD
      • Contact: Ashley Noriega; Phone Number: 323-865-3000; Email: Ashley.Noriega@med.usc.edu
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Los Angeles County-USC Medical Center
      • Principal Investigator: Heinz-Josef Lenz, MD
      • Contact: Ashley Noriega; Phone Number: 323-865-3000; Email: Ashley.Noriega@med.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Hispanic patients diagnosed with colon or rectal cancer at University of Southern California (USC) Norris Cancer Hospital or Los Angeles County+USC Medical Center.

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Usual Care; Patients will receive standard educational materials prior to the return of their results to better understand the results.	Other: Usual Care Educational Materials; Standard education materials
Experimental: Arm 2: Intervention; 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.	Other: Intervention Educational Materials; CoGenes educational materials with video.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to recurrence (TTR)	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.	Assessed up to 6 years
Progression free survival (PFS)	Determined from start of treatment to time of progression or death (whichever comes first).	Assessed up to 6 years
Overall survival (OS)	Determined from start of treatment until death due to any cause.	Assessed up to 6 years
Changes in genomic knowledge	The KnowGene scale will be used. Score Range = 0-16. Higher score indicates higher knowledge.	Baseline, at 2 weeks, and at 12-month follow up

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Heinz-Josef Lenz, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): May 25, 2028

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 3C-21-3 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2022-10775 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U2CCA252971 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No