What is the mechanism of action of this treatment?

Common cancer treatments often involve targeted therapies, which work by identifying and attacking specific genetic mutations or molecular markers present in cancer cells. For example, therapies targeting the PD-1/PD-L1 pathway help the immune system recognize and destroy cancer cells, while others may inhibit specific proteins involved in tumor growth and survival. The use of panel-based universal screening and EMR-based algorithms allows for the identification of these genetic markers, enabling personalized treatment plans that are more effective and have fewer side effects. This approach is crucial for cancer patients as it increases the likelihood of successful outcomes and minimizes unnecessary treatments.

What side effects are associated with this type of intervention?

Common treatments for cancer, such as checkpoint inhibitors, chemotherapy, and targeted therapies, have distinct side effect profiles. Checkpoint inhibitors often lead to immune-related adverse events including colitis, dermatitis, and hepatitis. Chemotherapy is known for causing nausea, vomiting, hair loss, and an increased risk of infection. Targeted therapies, particularly those aimed at specific genetic mutations like EGFR, frequently result in skin rash and diarrhea. These side effects are important considerations when selecting a treatment plan.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for cancer treatment, particularly those involving genetic testing to identify actionable mutations. For instance, pembrolizumab, an immune checkpoint inhibitor, is approved for cancers with high tumor mutational burden (TMB) or DNA mismatch repair deficiency. Rucaparib and niraparib, both PARP inhibitors, are approved for metastatic prostate cancer with homologous recombination repair (HRR) deficiencies. Additionally, cabozantinib, a tyrosine kinase inhibitor, is approved for medullary thyroid cancer. These approvals highlight the importance of genetic testing in guiding cancer treatment, aligning with the goals of the trial on panel-based universal screening and EMR-based algorithms.

What other types of research exist?

Promising novel alternatives for genetic risk ascertainment in cancer patients include: 1) Gene-mutation-based algorithms using machine learning, which have shown better precision in predicting treatment response, particularly in colorectal cancer. 2) Machine learning techniques for personalized risk prediction, which have demonstrated higher predictive accuracy compared to traditional models in breast cancer. 3) Liquid biopsy methods combining circulating tumor DNA and protein biomarkers, which offer potential for earlier detection of cancers such as pancreatic cancer.

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Genetic Testing

Genetic Testing for Young Adults with Cancer (Gen-Y Trial)

N/A

Recruiting

Led By Katherine L Nathanson, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Have a known genetic predisposition to cancer

Have a benign neoplasm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 15 months of proband enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a broad genetic test and automated computer systems to identify cancer risk in young adult cancer patients and their close relatives. It aims to catch genetic risks that traditional methods might miss, helping doctors manage these risks more efficiently.

Who is the study for?

This trial is for young adults aged 18-39, diagnosed with a solid tumor cancer within the last year and have visited Penn Medicine at least twice. It's not for those who already know they have a genetic predisposition to cancer, have certain types of thyroid or in situ cancers, leukemia, or had previous genetic testing after their diagnosis.

What is being tested?

The study tests if using broad gene panels for genetic screening can better identify genetic risks in young adults with cancer compared to standard practices. It uses EMR-based algorithms aiming to simplify the process and potentially involve patients' relatives as well.

What are the potential side effects?

Since this trial involves genetic testing rather than drug treatment, there are no direct physical side effects like you'd expect from medication. However, participants may experience emotional or psychological impacts from learning about their genetic risks.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a genetic condition that increases my cancer risk.

Select...

I have a non-cancerous tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 15 months of proband enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 15 months of proband enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 15 months of proband enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phenotype-based vs panel-based sequencing

Secondary study objectives

Completion of genetic testing among first-degree relatives of probands

Impact of clinical decision support

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Universal genetic testingExperimental Treatment1 Intervention

Detection of genetic risk using a broad panel of cancer risk genes.

Group II: StandardActive Control1 Intervention

We will refer a subset of patients who meet guideline criteria based on age, cancer type, and family history, for genetic counseling and testing.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments often involve targeted therapies, which work by identifying and attacking specific genetic mutations or molecular markers present in cancer cells. For example, therapies targeting the PD-1/PD-L1 pathway help the immune system recognize and destroy cancer cells, while others may inhibit specific proteins involved in tumor growth and survival. The use of panel-based universal screening and EMR-based algorithms allows for the identification of these genetic markers, enabling personalized treatment plans that are more effective and have fewer side effects. This approach is crucial for cancer patients as it increases the likelihood of successful outcomes and minimizes unnecessary treatments.

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