Confronting Cancer as a Community

April 12, 2024 updated by: University of Southern California
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

Intervention / Treatment

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 characterize the gut microbiome through a stool collection kit and nucleic acid extraction process.

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.

OUTLINE: This is an observational 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.

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

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Principal Investigator:
          • Heinz-Josef Lenz, MD
        • Contact:
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Los Angeles County-USC Medical Center
        • Principal Investigator:
          • Heinz-Josef Lenz, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (stool, blood, tissue, genetic testing, questionnaires)
Patients undergo stool sample collection, 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.
Other: Electronic Health Record Review
Medical records reviewed
Other: Genetic Testing
Undergo genetic testing
Other Names:
  • Genetic Examination
  • Genetic Test
  • Genetic Analysis
Other: Questionnaire Administration
Complete questionnaires
Procedure: Biospecimen Collection
Undergo stool and blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Stool Sample Collection
Procedure: Archive Sample Retrieval
Undergo collection of archival tumor tissue
Other Names:
  • ARCHIVE RETRIEVING

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recurrence (TTR)
Time Frame: Assessed up to 6 years
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)
Time Frame: Assessed up to 6 years
Determined from start of treatment to time of progression or death (whichever comes first).
Assessed up to 6 years
Overall survival (OS)
Time Frame: Assessed up to 6 years
Determined from start of treatment until death due to any cause.
Assessed up to 6 years
Changes in genomic knowledge
Time Frame: Baseline, at 2 weeks, and at 12-month follow up
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Heinz-Josef Lenz, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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