Germline Testing for Predisposition to Myeloid Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MyeloGen Gene Panel.
- Who it may be relevant to
- Registry conditions: Myeloid Malignancy, Genetic Predisposition to Disease, Myeloid Hematological Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies
Overview
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.
Interventions
- Device MyeloGen Gene Panel
The MyeloGen Gene Panel is investigational Germline genetic testing using skin fibroblasts.
Primary outcome measures
- Successful Completion Rate [Time frame: Up to 10 weeks]
Secondary outcome measures (3)
- Number of Participants with Positive Results [Time frame: Up to 12 weeks]
- Patient Reported Outcome of Germline Genetic Testing based on GST Survey [Time frame: 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 [Time frame: Up to 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Dana-Farber Cancer Institute — Boston
Identifiers
NCT: NCT07112287 · 25-218