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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 15 months of proband enrollment
Awards & highlights
Gen-Y Trial Summary
This trial will test whether or not panel-based genetic screening of young adults with cancer can help to improve the identification of genetic risk in these individuals and their relatives.
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.Check my eligibility
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.See study design
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.
Gen-Y Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phenotype-based vs panel-based sequencing
Secondary outcome measures
Completion of genetic testing among first-degree relatives of probands
Impact of clinical decision support
Gen-Y 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.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,002 Previous Clinical Trials
42,879,761 Total Patients Enrolled
Katherine L Nathanson, MDPrincipal InvestigatorUniversity of Pennsylvania
Steven Joffe, MDPrincipal InvestigatorUniversity of Pennsylvania
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with my current cancer less than a year ago.I have had genetic testing for my cancer.You can participate in the study if you meet these requirements:You will not be able to participate in the study if you meet any of these conditions:I have a genetic condition that increases my cancer risk.I have been diagnosed with in situ cancer, thyroid cancer, or leukemia.I was diagnosed with a solid tumor when I was 18-39 years old.I have a non-cancerous tumor.
Research Study Groups:
This trial has the following groups:- Group 1: Universal genetic testing
- Group 2: Standard
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age criterion for enrollment in this clinical trial limited to those over 35 years old?
"This study permits 18-40 year old patients to participate. Conversely, there are 61 trials for minors and 432 studies that cater specifically to elderly individuals."
Answered by AI
Could I possibly qualify for participation in this clinical trial?
"To gain admittance to this trial, people must be within the 18-40 age bracket and have a malignancy. 1238 individuals are sought for participation in total."
Answered by AI
Are there currently any open registrations for this research effort?
"The information available on clinicaltrials.gov reflects that enrollment for this trial has already commenced, with the initial post having been made December 1st 2020 and revised October 6th 2021."
Answered by AI
What is the current recruitment number for this trial?
"Indeed, the information concerning this trial hosted on clinicaltrials.gov evidences its recruiting status. This medical study was first posted in December 2020 and updated most recently in October 2021 with a goal of enrolling 1238 patients from one site."
Answered by AI
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