232 Participants Needed

Gene PilotLX for Cancer

Recruiting at 3 trial locations
MJ
SB
Overseen BySarah B Bass, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Fox Chase Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This is a randomized controlled trial designed to evaluate the efficacy of an electronic health decision support tool called Gene PilotLX to increase informed decision making regarding hereditary risk information from tumor genomic profiling (TGP) test among Latinx cancer patients recruited at four cancer centers.

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 safety data exists for Gene PilotLX or similar treatments?

The safety data for ALK inhibitors, which are similar to Gene PilotLX, show that they generally have a favorable safety profile with most side effects being mild to moderate. Common side effects can often be managed by adjusting the dose, and no new safety concerns have been observed in long-term studies.12345

How does the treatment Gene PilotLX differ from other cancer treatments?

Gene PilotLX may involve targeting specific genes like NKX2-1/TTF-1, which have a dual role in cancer progression, potentially offering a unique approach compared to standard treatments that do not focus on these genetic factors.678910

Research Team

SB

Sarah B Bass, PhD, MPH

Principal Investigator

Temple University

TA

Tracey A Revenson, PhD

Principal Investigator

Hunter College of City University of New York

MJ

Michael J. Hall

Principal Investigator

Fox Chase Cancer Center

Eligibility Criteria

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 am Latinx with a solid tumor cancer diagnosis.
I can speak and read either English or Spanish.
Patients who can provide informed consent

Exclusion Criteria

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

Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Gene PilotLXExperimental Treatment1 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 brochureActive Control1 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.

Find a Clinic Near You

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+

Findings from Research

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.
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.
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]
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.
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]

References

Postmarketing safety of anaplastic lymphoma kinase (ALK) inhibitors: an analysis of the FDA Adverse Event Reporting System (FAERS). [2022]
Management of crizotinib therapy for ALK-rearranged non-small cell lung carcinoma: an expert consensus. [2018]
Clinical Impact of Switching to Ceritinib After Severe AEs Related to Crizotinib/Alectinib in a Novel PTH2R-ALK Fusion Lung Adenocarcinoma: A Case Report. [2022]
Clinical experience and management of adverse events in patients with advanced ALK-positive non-small-cell lung cancer receiving alectinib. [2023]
Envonalkib versus crizotinib for treatment-naive ALK-positive non-small cell lung cancer: a randomized, multicenter, open-label, phase III trial. [2023]
NKX2-1/TTF-1: an enigmatic oncogene that functions as a double-edged sword for cancer cell survival and progression. [2022]
Expression, Clinical Significance, and Functional Prediction of MNX1 in Breast Cancer. [2021]
Oncogenic cooperation and coamplification of developmental transcription factor genes in lung cancer. [2021]
Significant association and synergistic adverse prognostic effect of podocalyxin-like protein and epidermal growth factor receptor expression in colorectal cancer. [2018]
Podocalyxin-like protein as a predictive biomarker for benefit of neoadjuvant chemotherapy in resectable gastric and esophageal adenocarcinoma. [2023]
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