Clinical trial NCT06063928: Confronting Cancer as a Community
Official title: Confronting Cancer as a Community
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Carcinoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-10-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Time to recurrence (TTR)
timeFrame: Assessed up to 6 years
measure: Progression free survival (PFS)
timeFrame: Assessed up to 6 years
measure: Overall survival (OS)
timeFrame: Assessed up to 6 years
measure: Changes in genomic knowledge
timeFrame: Baseline, at 2 weeks, and at 12-month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County-USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Heinz-Josef Lenz, MD
role: PRINCIPAL_INVESTIGATOR
References: