Genetic Testing in Young Adults With Cancer Study

NCT04533555 | Completed

• 2 other identifiers: 843047848530
• Study Type: interventional
• Target: 749
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of our research is to define an evidence-based, sustainable approach to identifying and managing genetic risk among young adults with cancer and their relatives. Conventional practice leaves referral and testing decisions to mostly non-expert clinicians implementing complex guidelines at the point of care, leading to substantial under-utilization. The investigators hypothesize that panel-based universal screening coupled with electronic medical record- (EMR-) based algorithms can improve ascertainment of genetic risk by functioning as an automated, radically simplified default practice in place of repeated single decisions requiring clinician cognitive effort and action. A secondary goal is to explore differences in ascertainment of genetic risk among first-degree relatives of probands.

Conditions

Cancer

Keywords

Young Adult cancers

Outcome Measures

Primary Outcomes (1)

• Phenotype-based vs panel-based sequencing

  comparison of proportions of patients with P/LP germline variants between the two study arms

  within 3 mos of study enrollment

Secondary Outcomes (2)

• Impact of clinical decision support

  within 2 years of study enrollment

• Completion of genetic testing among first-degree relatives of probands

  within 15 months of proband enrollment

Study Arms (2)

Universal genetic testing

EXPERIMENTAL

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

Genetic: Broad gene panel for young adult cancers

Standard

ACTIVE COMPARATOR

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

Genetic: Standard

Interventions

Broad gene panel for young adult cancers GENETIC

Genetic testing will occur using a broad gene panel for young adult cancers

Universal genetic testing

Standard GENETIC

Those in the standard group who are considered high risk will have genetic testing done using the standard of care panel as selected by their care provider.

Standard

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients will be eligible if they meet the following criteria:
• Diagnosed with a solid tumor between age 18-39 (patients may be 40 years of age at time of enrollment)
• Within one year of diagnosis with index cancer
• Have had at least two visits at Penn Medicine for the cancer diagnosis (to exclude one-time second opinions)

You may not qualify if:

• Patients will be excluded if they meet any of the following criteria:
• Diagnosis of in situ cancer, thyroid cancer (papillary or follicular), or leukemia Breast cancer diagnosis (aim 1 only)
• Have a known genetic predisposition to cancer
• Underwent genetic testing after this cancer diagnosis
• Have a benign neoplasm

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (45)

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Related Links

• National Cancer Institute NIH. A Snapshot of Adolescent and Young Adult Cancers. 2014.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Katherine L Nathanson, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Steven Joffe, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pearl Basser Professor of BRCA-Related Research; Deputy Director

Model Details: The study is a randomized controlled trial among young adult cancer patients that will compare an investigational strategy for detecting genetic risk (universal testing of all eligible patients using a broad panel of cancer risk genes) vs. the standard strategy (referring the subset of patients who meet certain guideline criteria, based on age, cancer type, and family history, for genetic counseling and testing). We will test the hypothesis that the investigational strategy detects substantially more patients as having genetic risk than the standard strategy.

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 31, 2020
• Study Start: December 1, 2020
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)