Genetic Testing for Colorectal Cancer

Recruiting at 1 trial location

Overseen By Ashley Noriega

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Inability to consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why Hispanic patients with colorectal cancer respond differently to treatments. Researchers will collect blood, stool, and tissue samples, along with genetic information, to explore the impact of genetics on treatment outcomes. The goal is to develop personalized medicine, identifying the best treatment for each individual based on their unique genetic makeup. This trial may suit Hispanic individuals who have been diagnosed with colon or rectal cancer and have a tumor sample available. As an unphased study, it offers a unique opportunity to contribute to groundbreaking research that could lead to more effective, personalized treatments for Hispanic patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that genetic testing is safe for patients?

Research has shown that genetic testing is generally safe for physical health. The process typically involves taking samples like blood, stool, or tissue, which is routine and low-risk. However, non-physical risks, such as emotional or social effects, should be considered. For instance, discovering genetic risks might cause anxiety or stress.

Privacy is a significant concern with genetic testing. Personal genetic information can be sensitive, and ongoing discussions focus on how to best protect this data. Despite these concerns, many people value having access to their genetic information.

Overall, genetic testing is well-tolerated, with minimal physical risks. The main considerations are emotional impacts and privacy issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it takes a comprehensive approach to understanding cancer by analyzing various aspects of a patient's biology and lifestyle. Unlike typical treatments that focus solely on attacking the cancer cells, this approach involves collecting stool and blood samples, analyzing tumor tissues, performing genetic testing, and using detailed questionnaires. The goal is to gather a holistic view of how different factors might contribute to cancer progression and response to treatment. By doing so, the trial aims to uncover new insights that could lead to more personalized and effective cancer therapies in the future.

What evidence suggests that genetic testing is effective for understanding colorectal cancer in Hispanic patients?

Research shows that genetic testing, which participants in this trial will undergo, serves as an important tool in cancer treatment. Studies have found that it identifies specific genetic changes in tumors, guiding personalized treatment plans. Testing for these changes has improved cancer monitoring and treatment. It also explains why individuals with the same type of cancer might respond differently to the same treatment. By understanding these genetic differences, doctors can tailor treatments to each person's unique needs. This personalized approach can lead to better outcomes and higher patient satisfaction. ^{6 7 8 9 10}

Who Is on the Research Team?

Heinz-Josef Lenz, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

Inclusion Criteria

You have been diagnosed with either colon or rectal cancer at any time in your life, regardless of the stage.

You have or intend to retain a tumor tissue specimen from an accepted medical protocol.

You have identified yourself as Hispanic or Latinx.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

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.

12 months

Initial visit for sample collection and questionnaires, followed by periodic reviews

Follow-up

Participants are monitored for safety and effectiveness after initial observational activities, with follow-ups at 2 weeks, 12 months, and annually thereafter.

6 years

Follow-up visits at 2 weeks, 12 months, and annually

What Are the Treatments Tested in This Trial?

Interventions

• Genetic Testing

How Is the Trial Designed?

Group I: Observational (stool, blood, tissue, genetic testing, questionnaires) Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10765765/

Genetic Testing for Successful Cancer Treatment - PMC Genetic testing for cancer-related disorders has significantly improved in accuracy and affordability, potentially revolutionizing monitoring ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1098360023009966

Systematic evidence review and meta-analysis of ... We conducted a systematic review and meta-analysis of 17 patient-reported and health-services-related outcomes associated with pre- and post-test GC in GCRA.

3. ajog.org ajog.org/article/S0002-9378(25)00259-5/fulltext

Uptake and patient-related outcomes of mainstreaming ... Key findings. The overall uptake of mainstreaming genetic testing across all cancer types was 91%. Mainstreaming was associated with high patient satisfaction ...

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2811619

Diagnostic Outcomes of Concurrent DNA/RNA Sequencing ... This diagnostic study assesses the outcomes of paired DNA and RNA testing on detection of disease-causing germline genetic variants and ...

5. cancer.gov cancer.gov/about-cancer/causes-prevention/genetics/genetic-testing-fact-sheet

Genetic Testing Fact Sheet - NCI A fact sheet about genetic testing for inherited cancer risk. Includes who should consider testing, and how to understand test results.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6616921/

Direct-to-Consumer Genetic Testing Data Privacy - PMC - NIH 89.9% felt individuals should have a right to access their own genetic information without a gatekeeping medical professional. · 83.2% of consumers felt it ...

7. nature.com nature.com/articles/s41436-020-0876-4

Clinical outcomes of a genomic screening program for ... Genomic screening programs can identify previously unrecognized individuals at increased risk of cancer and heart disease and facilitate risk management and ...

8. medlineplus.gov medlineplus.gov/genetics/understanding/testing/riskslimitations/

What are the risks and limitations of genetic testing? There are different kinds of risks involved with genetic testing. These include physical, emotional, social, or financial.

9. ama-assn.org ama-assn.org/practice-management/hipaa/protect-sensitive-individual-data-risk-dtc-genetic-tests

Protect sensitive individual data at risk from DTC genetic tests At-home kits to test DNA carry more risks than consumers realize. The AMA says it's time for new privacy standards to govern this burgeoning market.

10. cnbc.com cnbc.com/2018/06/16/5-biggest-risks-of-sharing-dna-with-consumer-genetic-testing-companies.html

5 biggest risks of sharing your DNA with consumer genetic- ... Consumer DNA genetic testing kits are a booming business, and the biggest risk isn't necessarily uncovering a health scare; it's what these ...