Trial Title:
Confronting Cancer as a Community
NCT ID:
NCT06063928
Condition:
Colorectal Carcinoma
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Archive Sample Retrieval
Description:
Undergo collection of archival tumor tissue
Arm group label:
Observational (stool, blood, tissue, genetic testing, questionnaires)
Other name:
ARCHIVE RETRIEVING
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo stool and blood sample collection
Arm group label:
Observational (stool, blood, tissue, genetic testing, questionnaires)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Other name:
Stool Sample Collection
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Medical records reviewed
Arm group label:
Observational (stool, blood, tissue, genetic testing, questionnaires)
Intervention type:
Other
Intervention name:
Genetic Testing
Description:
Undergo genetic testing
Arm group label:
Observational (stool, blood, tissue, genetic testing, questionnaires)
Other name:
Genetic Analysis
Other name:
Genetic Examination
Other name:
Genetic Test
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Complete questionnaires
Arm group label:
Observational (stool, blood, tissue, genetic testing, questionnaires)
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.
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.
Criteria for eligibility:
Study pop:
Hispanic patients diagnosed with colon or rectal cancer at University of Southern
California (USC) Norris Cancer Hospital or Los Angeles County+USC Medical Center.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Los Angeles County-USC Medical Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Noriega
Phone:
323-865-3000
Email:
Ashley.Noriega@med.usc.edu
Investigator:
Last name:
Heinz-Josef Lenz, MD
Email:
Principal Investigator
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Noriega
Phone:
323-865-3000
Email:
Ashley.Noriega@med.usc.edu
Investigator:
Last name:
Heinz-Josef Lenz, MD
Email:
Principal Investigator
Start date:
May 25, 2022
Completion date:
May 25, 2028
Lead sponsor:
Agency:
University of Southern California
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Southern California
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06063928
