MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myeloid Malignancy
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 200
- Primary Endpoint
- Incidence Rate of Positive Genetic Results
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
This research study is evaluating the feasibility of conducting cancer genetic testing using healthy skin cells among participants with a diagnosis of a blood cancer. Additionally, investigators will evaluate how often participants with blood cancers are found to have risk for cancer based on family genes.
Detailed Description
The purpose of this prospective, non-randomized, non-therapeutic, single arm study is to determine the feasibility and benefit of performing genetic testing for all participants with a blood cancer diagnosis regardless of clinical suspicion. Research study procedures include screening for eligibility, in-clinic visits, questionnaires, and skin punch biopsies. Participants will receive germline genetic testing with a comprehensive hereditary cancer gene panel. It is expected that about 200 individuals with blood cancer will take part in this research study.
Investigators
Christopher Reilly
Principle Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •Age of 18 years or older
- •Participants must have 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 or Spanish.
Exclusion Criteria
- •Patients with who cannot safely undergo skin biopsy as adjudicated by the study team.
- •Patients who have previously undergone germline genetic testing for predisposition to myeloid malignancies
Outcomes
Primary Outcomes
Incidence Rate of Positive Genetic Results
Time Frame: Up to 63 months
Defined as the proportion of participants with a "positive" result on the germline genetic testing. Positive results equal Variants classified as Pathogenic (P), Likely pathogenic (LP), or Variants of Uncertain Significance (VUS) with supporting pathogenic criteria.
Genetic Testing Completion Rate
Time Frame: Up to 63 months
Feasibility is defined as a minimum of 75% of consented participants complete germline genetic testing with the return of test results within 10 weeks of study consent.
Secondary Outcomes
- Participant Satisfaction Score on GTS Survey 2(Up to 130 days from baseline)
- Multidimensional Impact of Cancer Risk Assessment (MICRA) Score(Up to 130 days from baseline)
- Detection Rate of Germline Predisposition(Up to 63 months)
- Impact of Genetic Results on Clinical Decision-Making(Up to 130 days from baseline)
- Participant Knowledge of Genetic Testing Post-Education(At baseline, following pre-educational video)
- Participant Satisfaction Score on Genetic Testing Satisfaction (GTS) Survey 1(At baseline)
- Participant Knowledge of Genetic Testing Pre-Education(At baseline)
- Participant Decisional Regret Score(Up to 130 days from baseline)