Recruiting

Personalized Medicine

Sponsor:

University of Southern California

Code:

NCT06063928

Conditions

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Usual Care Educational Materials

Intervention Educational Materials

Study Details

Brief 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.

Conditions

Colorectal Carcinoma

Study ID

NCT06063928

Start date

May 25, 2022

Status verified date

May, 2026

Completion date

May 25, 2028

Anticipated

Primary completion date

May 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm 1: Usual Care

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

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.

Interventions

Usual Care Educational Materials

Standard education materials

Intervention Educational Materials

CoGenes educational materials with video.

Primary outcome measure

  • Time to recurrence (TTR) [ Time Frame: Assessed up to 6 years ]
  • Progression free survival (PFS) [ Time Frame: Assessed up to 6 years ]
  • Overall survival (OS) [ Time Frame: Assessed up to 6 years ]
  • Changes in genomic knowledge [ Time Frame: Baseline, at 2 weeks, and at 12-month follow up ]

Central Contacts and Locations

Central contacts

Ashley Noriega

323-865-3000Ashley.Noriega@med.usc.edu

Locations

Los Angeles County-USC Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Ashley Noriega

323-865-3000Ashley.Noriega@med.usc.edu

Principal Investigator:

Heinz-Josef Lenz, MD

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Ashley Noriega

323-865-3000Ashley.Noriega@med.usc.edu

Principal Investigator:

Heinz-Josef Lenz, MD

More Information

Sponsor

University of Southern California

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-06-02.