NCT06063928

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
May 2022May 2028

Study Start

First participant enrolled

May 25, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2028

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

September 6, 2023

Last Update Submit

January 8, 2026

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Arm 1: Usual Care

EXPERIMENTAL

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

Other: Usual Care Educational Materials

Arm 2: Intervention

EXPERIMENTAL

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

Interventions

Usual Care Educational MaterialsOTHER

Standard education materials

Arm 1: Usual Care
Intervention Educational MaterialsOTHER

CoGenes educational materials with video.

Arm 2: Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Heinz-Josef Lenz, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Noriega

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2023

First Posted

October 3, 2023

Study Start

May 25, 2022

Primary Completion (Estimated)

May 25, 2027

Study Completion (Estimated)

May 25, 2028

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

US(2)