Germline Testing for Predisposition to Myeloid Malignancies

NCT07112287 | Recruiting FDA Device

• 1 other identifier: 25-218
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloid Malignancy; Genetic Predisposition to Disease; Myeloid Hematological Malignancies

Keywords

Myeloid Malignancies; Genetic Predisposition to Disease

Outcome Measures

Primary Outcomes (1)

• Successful Completion Rate

  Successful completion rate of germline genetic testing will be defined as the proportion of participants who return genetic test results within 10 weeks of study consent, which would require there be no excessive delays in obtaining a skin biopsy.

  Up to 10 weeks

Secondary Outcomes (3)

• Number of Participants with Positive Results

  Up to 12 weeks

• Patient Reported Outcome of Germline Genetic Testing based on GST Survey

  Up to 60 days

• Number of Participants with an Identified Germline Predisposition on Generic Testing Who Haven't Met NCNN Guideline-based Germline Genetic Testing Recommendations

  Up to 12 weeks

Study Arms (1)

MyeloGen Germline Testing Group

EXPERIMENTAL

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.

Device: MyeloGen Gene Panel

Interventions

MyeloGen Gene Panel DEVICE

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

Also known as: Custom hereditary cancer gene panel

MyeloGen Germline Testing Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Christopher Reilly: lead
• Broad Institute of MIT and Harvard: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher R Reilly, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher R Reilly, MD

CONTACT

407-443-6243; Christopherr_reilly@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2033
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)