Actively Recruiting
MyeloGen Germline Testing for Predisposition to Myeloid Malignancies
Led by Christopher Reilly · Updated on 2026-04-24
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
C
Christopher Reilly
Lead Sponsor
B
Broad Institute of MIT and Harvard
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of using the investigational MyeloGen Gene Panel to conduct germline genetic testing in adults diagnosed with myeloid malignancies. This prospective, single-arm study aims to learn how to best incorporate routine genetic testing into clinical care for people with blood cancers, regardless of their personal or family history. The study is sponsored by the Broad Clinical Laboratory and led by Christopher Reilly. Participants will undergo a baseline visit including questionnaires, watching an educational video, and a punch skin biopsy to collect skin fibroblasts for genetic testing. Negative genetic test results will be sent by mail, while positive results will be followed up with an appointment with a genetic counselor or physician. Participants will complete post-results questionnaires and have their medical records followed for up to two years from the time of consent. During the study, participants will attend in-clinic visits for assessments and provide skin biopsy samples. Researchers will measure the successful completion rate of the testing within 10 weeks and track the number of participants with positive genetic findings within 12 weeks. Patient-reported outcomes based on surveys will be collected up to 60 days after testing. The study includes follow-up through medical records for up to two years to monitor outcomes and care.
CONDITIONS
Brief Title
Germline Testing for Predisposition to Myeloid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18 years or older
- Histologically confirmed myeloid malignancy or bone marrow failure within the last 6 months prior to screening
- Ability to understand and provide a signed and completed consent document in English
You will not qualify if you...
- Unable to safely undergo clinically indicated skin biopsy as determined by the study team
- Previous germline genetic testing for predisposition to myeloid malignancies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 10 weeks
Participants undergo germline genetic testing using the investigational MyeloGen Gene Panel with a punch skin biopsy and complete baseline questionnaires and educational materials.
1 baseline visit (in-person)
Duration - Up to 2 years from time of study consent
Participants are followed up via medical records and may receive genetic counseling or physician appointments based on test results, along with post-results questionnaires.
Follow-up visits depending on genetic test results
Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
C
Christopher R Reilly, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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