Germline Testing for Predisposition to Myeloid Malignancies

NCT ID: NCT07112287

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2033-04-01

Brief 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.

Conditions

Myeloid Malignancy; Genetic Predisposition to Disease; Myeloid Hematological Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

MyeloGen Germline Testing Group

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.

Group Type: EXPERIMENTAL

MyeloGen Gene Panel

Intervention Type: DEVICE

The MyeloGen Gene Panel is investigational Germline genetic testing using skin fibroblasts.

Interventions

MyeloGen Gene Panel

The MyeloGen Gene Panel is investigational Germline genetic testing using skin fibroblasts.

Intervention Type: DEVICE

Other Intervention Names

Custom hereditary cancer gene panel

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Broad Institute of MIT and Harvard

OTHER

Sponsor Role: collaborator

Christopher Reilly

OTHER

Sponsor Role: lead

Responsible Party

Christopher Reilly

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christopher R Reilly, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Christopher R Reilly, MD

Role: CONTACT

Christopherr_reilly@dfci.harvard.edu

407-443-6243

Other Identifiers

25-218

Identifier Type: -

Identifier Source: org_study_id