The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT06063928
Previous Study | Return to List | Next Study

Confronting Cancer as a Community

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06063928
Recruitment Status : Recruiting
First Posted : October 3, 2023
Last Update Posted : April 16, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Colorectal Carcinoma Procedure: Archive Sample Retrieval Procedure: Biospecimen Collection Other: Electronic Health Record Review Other: Genetic Testing Other: Questionnaire Administration

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Confronting Cancer as a Community
Actual Study Start Date : May 25, 2022
Estimated Primary Completion Date : May 25, 2027
Estimated Study Completion Date : May 25, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Procedure: Archive Sample Retrieval
Undergo collection of archival tumor tissue
Other Name: ARCHIVE RETRIEVING

Procedure: Biospecimen Collection
Undergo stool and blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Stool Sample Collection

Other: Electronic Health Record Review
Medical records reviewed

Other: Genetic Testing
Undergo genetic testing
Other Names:
  • Genetic Analysis
  • Genetic Examination
  • Genetic Test

Other: Questionnaire Administration
Complete questionnaires


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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).

  3. Overall survival (OS) [ Time Frame: Assessed up to 6 years ]
    Determined from start of treatment until death due to any cause.

  4. 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.


Biospecimen Retention:   Samples With DNA
Blood and archival tumor tissue

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06063928


Contacts
Layout table for location contacts
Contact: Ashley Noriega 323-865-3000 Ashley.Noriega@med.usc.edu

Locations
Layout table for location information
United States, California
Los Angeles County-USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Ashley Noriega    323-865-3000    Ashley.Noriega@med.usc.edu   
Principal Investigator: Heinz-Josef Lenz, MD         
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Ashley Noriega    323-865-3000    Ashley.Noriega@med.usc.edu   
Principal Investigator: Heinz-Josef Lenz, MD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Heinz-Josef Lenz, MD University of Southern California
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT06063928    
Other Study ID Numbers: 3C-21-3
NCI-2022-10775 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
3C-21-3 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
U2CCA252971 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2023    Key Record Dates
Last Update Posted: April 16, 2024
Last Verified: April 2024

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases