MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies
Summary
The goal of this research study is to evaluate the feasibility of germline genetic testing using the investigational MyeloGen Gene Panel in adult participants diagnosed with myeloid malignancies.
Detailed description
This prospective, single arm study aims to evaluate the feasibility of germline genetic testing using the investigational MyeloGen Gene Panel in adult participants diagnosed with myeloid malignancies. Investigators hope to learn how to best incorporate routine genetic testing in clinical care for participants with blood cancers, regardless of personal or family history of blood cancer. The research study procedures include screening for eligibility, in-clinic visits, questionnaires, and punch skin biopsies. It is expected that about 200 people will take part in this research study. The laboratory sponsor of this protocol is Broad Clinical Laboratory.
Arms & interventions
- DeviceMyeloGen Gene Panel
The MyeloGen Gene Panel is investigational Germline genetic testing using skin fibroblasts.
Outcome measures
Primary
Successful Completion Rate
Successful completion rate of germline genetic testing will be defined as the proportion of participants who return genetic test results within 10 weeks of study consent, which would require there be no excessive delays in obtaining a skin biopsy.
Time frame: Up to 10 weeks
Secondary
Number of Participants with Positive Results
Time frame: Up to 12 weeks
Patient Reported Outcome of Germline Genetic Testing based on GST Survey
Time frame: Up to 60 days
Number of Participants with an Identified Germline Predisposition on Generic Testing Who Haven't Met NCNN Guideline-based Germline Genetic Testing Recommendations
Time frame: Up to 12 weeks
Eligibility criteria
Study locations (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215