Gene PilotLX for Cancer

Recruiting at 4 trial locations

Overseen By Sarah B Bass, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Disqualifiers: Hematologic cancers, others

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

Compensation: Varies

Number of Visits: 3

232 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Latinx cancer patients in making informed decisions about genetic information related to their tumors. It tests a tool called Gene PilotLX, which guides patients in understanding tumor genomic profiling—a test that can reveal inherited cancer risks—and facilitates discussions with doctors and family. Participants will either use this tool or receive a brochure with similar information. Latinx patients with solid tumors who speak English or Spanish may be suitable for this study. As an unphased trial, this study offers a unique opportunity for patients to actively engage in research that could enhance their understanding and management of cancer risks.

Do I need to stop my current medications for the Gene PilotLX trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Gene PilotLX tool is safe for use in Latinx cancer patients?

Research has shown that Gene PilotLX is popular with users. In studies, participants found it easy to use and felt it helped address important issues like medical mistrust and understanding genetic information. No reports linked the tool to safety concerns or negative effects. As an online decision-making tool rather than a medication, Gene PilotLX is unlikely to cause physical harm. This makes it a safe choice for those seeking to make informed decisions about genetic risks in cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Gene PilotLX is unique because it empowers Latinx cancer patients with a personalized decision-making tool for understanding secondary genetic information. Unlike standard informational brochures, it offers an interactive, web-based experience available in both English and Spanish, complete with voice-over guidance. This tool not only educates patients about tumor genomic profiling but also helps them communicate their preferences to doctors and discuss options with family, making them feel more informed and supported in their healthcare decisions. Researchers are excited about Gene PilotLX as it addresses cultural and language barriers, potentially leading to more personalized and effective patient care.

What evidence suggests that the Gene PilotLX tool is effective for increasing informed decision making in Latinx cancer patients?

Research shows that Gene PilotLX, available to participants in this trial, helps individuals make better decisions about genetic testing. Studies have found that users of this tool feel less confused and more prepared to make health choices. Designed specifically for Latinx cancer patients, it addresses their cultural needs. The tool aids users in understanding complex genetic information and facilitates communication with their doctors. Early findings suggest that Gene PilotLX outperforms the standard TGP brochure, provided to participants in the control arm, in reducing uncertainty and enhancing decision-making. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael J. Hall

Principal Investigator

Fox Chase Cancer Center

Sarah B Bass, PhD, MPH

Principal Investigator

Temple University

Tracey A Revenson, PhD

Principal Investigator

Hunter College of City University of New York

Are You a Good Fit for This Trial?

This trial is for Latinx cancer patients who are interested in making informed decisions about their hereditary risks based on tumor genomic profiling tests. Participants will be recruited from four cancer centers.

Inclusion Criteria

I can speak and read either English or Spanish.

I am Latinx with a solid tumor cancer diagnosis.

Patients who can provide informed consent

Exclusion Criteria

I have a blood cancer such as leukemia, lymphoma, or multiple myeloma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to either the Gene PilotLX tool or a TGP brochure to aid in decision-making about tumor genomic profiling.

1 day

1 visit (in-person or virtual)

Follow-up

Participants complete assessments to evaluate the efficacy of the intervention, including communication of preferences and decisional conflict.

1-3 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Gene PilotLX

Trial Overview The study is testing Gene PilotLX, an electronic health decision support tool, to see if it helps Latinx cancer patients understand the results of genetic tests that assess their risk of inherited cancer.

How Is the Trial Designed?

Group I: Gene PilotLX Experimental Treatment 1 Intervention

Gene PilotLX is an eHealth decision support tool that is designed to empower Latinx cancer patients to decide their preferences for learning about secondary genetic information, communicate those preferences to their doctors, and provide the opportunity to discuss information with their families or others to feel they have made an informed decision. The tool will be available in both English and Spanish. It is web-based, has a voice-over, and is easy to navigate, with simple forward and backward buttons. Each section includes a different aspect of tumor genomic profiling, from basic information about what the test is and what the pros and cons are of the test, to culturally specific potential barriers or benefits to learning hereditary results. At the end, the tool provides tailored potential questions for a doctor that users can choose, which are summarized in a "score card" that can be printed or emailed.

Group II: TGP brochure Active Control 1 Intervention

Participants in the control arm will be provided a brochure about tumor genomic profiling (TGP) secondary hereditary risks, and what patients can decide about getting that information, including the pros and cons. It is literacy appropriate, incorporates visuals, and will also be offered in both English and Spanish.

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Temple University

Collaborator

Trials

321

Recruited

89,100+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Herbert Irving Comprehensive Cancer Center

Collaborator

Trials

36

Recruited

1,300+

MD Anderson Cancer Center at Cooper

Collaborator

Trials

1

Recruited

230+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A male patient with stage IV lung adenocarcinoma carrying a novel PTH2R-ALK fusion experienced gastrointestinal adverse events (AEs) while on crizotinib and switched to alectinib, which remained effective despite the patient's condition.

After experiencing hyperbilirubinemia on ceritinib, the patient's dose was reduced, leading to relief from diarrhea AEs and achieving nearly 12 months of progression-free survival, highlighting the importance of dose management in treating NSCLC with ALK fusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Impact of Switching to Ceritinib After Severe AEs Related to Crizotinib/Alectinib in a Novel PTH2R-ALK Fusion Lung Adenocarcinoma: A Case Report. Shen, G., Du, Y., Shen, J., et al.[2022]

Alectinib has been shown to significantly improve progression-free survival and overall survival compared to crizotinib in patients with advanced ALK-positive non-small-cell lung cancer, as demonstrated in the phase III ALEX study and confirmed in subsequent studies in Japanese and Asian populations.

The safety profile of alectinib is manageable, with most adverse events being treatable through dose reduction, and no new safety concerns have emerged during long-term follow-up, reinforcing its recommendation as a preferred first-line therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience and management of adverse events in patients with advanced ALK-positive non-small-cell lung cancer receiving alectinib. Dziadziuszko, R., Peters, S., Ruf, T., et al.[2023]

A pharmacovigilance analysis of ALK inhibitors (crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib) revealed significant safety signals, including serious adverse events like pulmonary arterial hypertension and rectal perforation, indicating the need for further regulatory investigation.

Specific safety concerns were identified for each drug, such as eye disorders with crizotinib and myasthenia gravis with lorlatinib, highlighting the importance of monitoring these effects to inform patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postmarketing safety of anaplastic lymphoma kinase (ALK) inhibitors: an analysis of the FDA Adverse Event Reporting System (FAERS). Omar, NE., Fahmy Soliman, AI., Eshra, M., et al.[2022]

Crizotinib, an ALK inhibitor, has been established as a new standard of care for advanced ALK-positive non-small cell lung cancer (NSCLC) due to its significant efficacy and favorable safety profile observed in phase I, II, and III trials.

Most adverse events associated with crizotinib are mild to moderate, and with proper monitoring and supportive care, dose interruptions can often be avoided, allowing patients to continue benefiting from the treatment even after initial disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of crizotinib therapy for ALK-rearranged non-small cell lung carcinoma: an expert consensus. Cappuzzo, F., Moro-Sibilot, D., Gautschi, O., et al.[2018]

In a phase III trial involving 264 participants with advanced ALK-positive non-small cell lung cancer (NSCLC), envonalkib significantly improved progression-free survival (PFS) compared to crizotinib, with median PFS times of 24.87 months versus 11.60 months, respectively.

Envonalkib also demonstrated a higher objective response rate (81.68% vs. 70.68%) and better control of brain metastases, with a CNS objective response rate of 78.95% compared to 23.81% for crizotinib, indicating its potential as a more effective treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Envonalkib versus crizotinib for treatment-naive ALK-positive non-small cell lung cancer: a randomized, multicenter, open-label, phase III trial. Yang, Y., Min, J., Yang, N., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11189656

Project Details - NIH RePORTER H1: Those in the Gene PilotLX arm will have greater reduced decisional conflict and higher decision preparedness compared to the non-targeted decision aid. H2: ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06476938

Testing Gene PilotLX With Latinx Cancer Patients This is a randomized controlled trial designed to evaluate the efficacy of an electronic health decision support tool called Gene PilotLX to increase ...

3. frontiersin.org frontiersin.org/journals/communication/articles/10.3389/fcomm.2025.1505456/full

Development and user testing of gene pilot: an electronic ... To help increase self-efficacy and facilitate informed decision making around genetic testing, culturally-sensitive decision support tools (DSTs) ...

4. reporter.nih.gov reporter.nih.gov/project-details/10931648

Project Details H1: Those in the Gene PilotLX arm will have greater reduced decisional conflict and higher decision preparedness compared to the non-targeted ...

5. withpower.com withpower.com/trial/phase-malignancies-8-2024-ab0c9

Gene PilotLX for Cancer This is a randomized controlled trial designed to evaluate the efficacy of an electronic health decision support tool called Gene PilotLX to increase ...

6. reporter.nih.gov reporter.nih.gov/search/hnLl70a6yESJ_Aei3dvAEA/project-details/10931739

RePORT RePORTER - National Institutes of Health (NIH) | Test the impact of Gene PilotLX in a randomized trial. We will conduct a fully powered RCT with 232 Latinx cancer patients at four oncology sites.

7. policylab.us policylab.us/clinical-trials/l/conditions/cancer?page=7

Cancer Clinical Trials & Research Studies Near You (Updated 8/25) This is a randomized controlled trial designed to evaluate the efficacy of an electronic health decision support tool called Gene PilotLX to increase informed ...