Confronting Cancer as a Community
Study Overview
Status
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 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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ashley Noriega
- Phone Number: 323-865-3000
- Email: Ashley.Noriega@med.usc.edu
Study Locations
-
-
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
Study Population
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)
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.
|
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.
|
CoGenes educational materials with video.
|
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
Collaborators
Investigators
- Principal Investigator: Heinz-Josef Lenz, MD, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.