Clinical trial NCT06543511: MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies
Official title: MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Myeloid Malignancy
Myeloid Malignancies
Blood Cancer
Blood Cancers
Keywords: Myeloid Malignancy
Myeloid Malignancies
Blood Cancer
Blood Cancers
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Genetic Testing Completion Rate
timeFrame: Up to 63 months
measure: Incidence Rate of Positive Genetic Results
timeFrame: Up to 63 months
Secondary outcomes:
measure: Participant Knowledge of Genetic Testing Pre-Education
timeFrame: At baseline
measure: Participant Knowledge of Genetic Testing Post-Education
timeFrame: At baseline, following pre-educational video
measure: Participant Satisfaction Score on Genetic Testing Satisfaction (GTS) Survey 1
timeFrame: At baseline
measure: Participant Satisfaction Score on GTS Survey 2
timeFrame: Up to 130 days from baseline
measure: Multidimensional Impact of Cancer Risk Assessment (MICRA) Score
timeFrame: Up to 130 days from baseline
measure: Participant Decisional Regret Score
timeFrame: Up to 130 days from baseline
measure: Detection Rate of Germline Predisposition
timeFrame: Up to 63 months
measure: Impact of Genetic Results on Clinical Decision-Making
timeFrame: Up to 130 days from baseline
Other outcomes:
Locations:
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christopher Reilly, MD
role: PRINCIPAL_INVESTIGATOR
References: