Confronting Cancer as a Community

Colorectal Carcinoma Clinical Trial

Official title:

Confronting Cancer as a Community

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06063928
• Other study ID #: 3C-21-3
• Secondary ID: NCI-2022-107753C
• Status: Recruiting
• Start date: May 25, 2022
• Est. completion date: May 25, 2028

Study information

• Verified date: April 2024
• Source: University of Southern California
• Contact: Ashley Noriega
• Phone: 323-865-3000
• Email: Ashley.Noriega[@]med.usc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 25, 2028
• Est. primary completion date: May 25, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Procedure:
• Archive Sample Retrieval
Undergo collection of archival tumor tissue
• Biospecimen Collection
Undergo stool and blood sample collection

Other:
• Electronic Health Record Review
Medical records reviewed
• Genetic Testing
Undergo genetic testing
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	Los Angeles County-USC Medical Center	Los Angeles	California
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Progression free survival (PFS)	Determined from start of treatment to time of progression or death (whichever comes first).	Assessed up to 6 years
Primary	Overall survival (OS)	Determined from start of treatment until death due to any cause.	Assessed up to 6 years
Primary	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