MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies

Dana-Farber Cancer Institute

Status: Withdrawn

Conditions: Myeloid Malignancy; Blood Cancer; Myeloid Malignancies; Blood Cancers

Treatments: Other: Genetic Blood Test

Study type: Interventional

Funder types: Other

Identifiers

NCT06543511

24-087

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Germline Genetic Testing

Experimental group

Description:

Participants will be enrolled and will complete study procedures as follows: * Baseline visit with educational video and questionnaires. * Skin punch biopsy. * Genetic testing results. * Surveys and questionnaires. * Follow up via medical records for up to 2 years from time of study consent.

Treatment:

Other: Genetic Blood Test