Genetic Testing for Cancer

Not currently recruiting at 12 trial locations

Overseen By Katherine A. Janeway

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Brain tumors, Lymphoma, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a personalized cancer treatment approach by using genetic testing on solid tumors to identify gene changes that might respond to specific therapies. It aims to create a personalized treatment plan, called an individualized cancer therapy recommendation, based on the tumor's genetic profile. The trial seeks individuals diagnosed with solid tumors (excluding brain tumors or lymphoma) before age 30, whose tumors are hard to treat, have recurred, are high-risk at diagnosis, or are rare with no clear diagnosis. Participants should have enough tumor tissue available for testing or plan to undergo surgery or biopsy to provide it.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to the development of potentially effective therapies.

Will I have to stop taking my current medications?

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 tumor profiling is safe for patients?

Research shows that genetic testing is generally safe and easy for most people to handle. It helps researchers understand how different patients might react to certain treatments. Studies suggest that genetic testing can improve patient care by indicating how well a drug might work for someone and if it is safe for them.

However, some risks exist, mainly related to privacy. Sharing genetic information could reveal personal details. In a clinical trial, steps are usually taken to protect this information.

Overall, despite some privacy concerns, genetic testing is considered safe for participants and can offer valuable insights for personalized treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the genetic testing and GAIN report because they offer a personalized approach to treatment. Unlike standard treatments that follow a one-size-fits-all strategy, this method uses genomic sequencing to tailor therapies specific to an individual’s genetic makeup. This means that patients could potentially receive more effective treatments with fewer side effects, as therapies are chosen based on their unique genetic profile. The hope is that this targeted approach leads to better outcomes and a new era of precision medicine.

What evidence suggests that genetic testing and GAIN report are effective for individualized cancer therapy?

Research has shown that genetic testing and tumor profiling, which participants in this trial will undergo, can identify specific changes in tumor genes. These changes enable doctors to suggest treatments tailored to each patient. Studies indicate that this personalized approach can improve cancer management by focusing on the unique features of each person’s tumor. This method has been linked to better outcomes, such as fewer recurrences of the disease and possibly lower death rates. Genetic profiling also helps doctors make faster and more accurate diagnoses, which is crucial for effective cancer treatment. ^{2 6 7 8 9}

Who Is on the Research Team?

Katherine Janeway, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

Age -- Age ≤ 30 years at time of initial qualifying solid tumor diagnosis

Refractory, defined as tumor progression after initiation of standard first line therapy without having achieved a prior partial or complete remission OR Biopsy proven residual disease at the completion of planned standard initial front-line therapy.

Recurrent, defined as tumor progression after achieving a prior partial or complete remission

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Testing and Analysis

All enrolled patients will submit specimens for sequencing and analysis to identify potential targeted therapies

4-6 weeks

Treatment

Participants receive targeted therapy matched to an individualized cancer therapy (iCat) recommendation based on genetic testing results

18 months

Follow-up

Participants are monitored for overall survival, progression-free survival, and response rate after treatment

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Genetic testing and GAIN report

How Is the Trial Designed?

Group I: Genetic testing and GAIN report Experimental Treatment 1 Intervention

All enrolled patients will submit specimens for sequencing and analysis.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12235931/

Are we properly evaluating genetic and genomic testing? A ... Among 26 reports exploring the “effectiveness” component, common outcomes included all-cause mortality (50.0%), disease recurrence ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1098360024000029

Real-world diagnostic outcomes and cost-effectiveness of ... Using real-world data, we found earlier access to ES may yield more rapid genetic diagnosis of childhood developmental and seizure disorders and cost savings.

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

Clinical outcomes of a genomic screening program for ... Such outcomes include the rate of risk management among individuals with genetic results identified through a screening program and the degree ...

4. genomemedicine.biomedcentral.com genomemedicine.biomedcentral.com/articles/10.1186/s13073-023-01174-7

Diagnostic yield of genetic screening in a diverse, community ... Overall, 21 of 103 (20.5%) people with positive screening results and 116 of 2761 (4.2%) people with uninformative screening results were likely ...

5. thermofisher.com thermofisher.com/blog/behindthebench/what-should-health-systems-report-to-participants-in-genomics-screening-programs/

What Should Be Reported to Participants in a Genomics ... To minimize false positives, screening results should be interpreted more stringently when testing the general population compared to testing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9436979/

Recommendations for reporting results of diagnostic ... Results of clinical genomic testing must be reported in a clear, concise format to ensure they are understandable and interpretable.

7. wolterskluwer.com wolterskluwer.com/en/expert-insights/pharmacogenomics-is-improving-patient-safety-and-reducing-costs

Preemptive genetic testing in cardiovascular care Genetic testing for drug effectiveness and safety improves patient outcomes · Diminished antiplatelet effectiveness · Increased risk of adverse ...

8. 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 ...

9. genome.gov genome.gov/10002404/genetic-testing-reportchapter-2

Promoting Safe and Effective Genetic Testing in the United ... Before a genetic test can be generally accepted in clinical practice, data must be collected to demonstrate the benefits and risks that accrue ...