COMPLETED

Genetic Testing in Young Adults With Cancer Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Trial of Universal vs. Guideline-directed Germline Testing Among Young Adults With Cancer

Quick Facts

Study Start:2020-12-01
Study Completion:2025-09-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04533555

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients will be eligible if they meet the following criteria:
  2. * Diagnosed with a solid tumor between age 18-39 (patients may be 40 years of age at time of enrollment)
  3. * Within one year of diagnosis with index cancer
  4. * Have had at least two visits at Penn Medicine for the cancer diagnosis (to exclude one-time second opinions)
  1. * Diagnosis of in situ cancer, thyroid cancer (papillary or follicular), or leukemia Breast cancer diagnosis (aim 1 only)
  2. * Have a known genetic predisposition to cancer
  3. * Underwent genetic testing after this cancer diagnosis
  4. * Have a benign neoplasm

Contacts and Locations

Principal Investigator

Katherine L Nathanson, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Steven Joffe, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Katherine L Nathanson, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
  • Steven Joffe, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-01
Study Completion Date2025-09-26

Study Record Updates

Study Start Date2020-12-01
Study Completion Date2025-09-26

Terms related to this study

Keywords Provided by Researchers

  • Young Adult cancers

Additional Relevant MeSH Terms

  • Cancer