Germline Testing for Predisposition to Myeloid Malignancies (MyeloGen)

Christopher Reilly

Status: Not yet enrolling

Conditions: Myeloid Malignancy; Genetic Predisposition to Disease; Myeloid Hematological Malignancies

Treatments: Device: MyeloGen Gene Panel

Study type: Interventional

Funder types: Other

Identifiers

NCT07112287

25-218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

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.

Exclusion criteria

• Participants who cannot safely undergo clinically indicated skin biopsy as adjudicated by the study team.
• Participants who have previously undergone germline genetic testing for predisposition to myeloid malignancies

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

MyeloGen Germline Testing Group

Experimental group

Description:

Enrolled participants will complete: * Baseline visit with questionnaires, educational video, and punch skin biopsy * Negative genetic test results notification via mail * Positive genetic results will be followed up by an appointment with a genetic counselor or physician * Post-results questionnaires * Follow up via medical records for up to 2 years from time of study consent.

Treatment:

Device: MyeloGen Gene Panel