An interventional study of MyeloGen Gene Panel in Myeloid Malignancy, Genetic Predisposition to Disease and Myeloid Hematological Malignancies, sponsored by Christopher Reilly. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Christopher Reilly · Not applicable, Interventional, and Screening
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.
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.
235 studies on the registry are indexed under Genetic Predisposition to Disease; 94 are open to participants now.
This study's planned enrollment of 200 is close to the median of 216 across 81 interventional studies indexed under Genetic Predisposition to Disease.
Browse Genetic Predisposition to Disease studies →This is the only study on the registry with Christopher Reilly as lead sponsor.
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Exclusion Criteria:
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
The MyeloGen Gene Panel is investigational Germline genetic testing using skin fibroblasts.
Also known as: Custom hereditary cancer gene panel
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.
Time frame: Up to 10 weeks
Number of Participants with Positive Results
A "positive" result indicating a pathogenic or likely pathogenic variant was detected. This will also include Variants of Unknown Significance (VUSs) with supporting pathogenic criteria per American College of Medical Genetics guidelines (ACMG).
Time frame: Up to 12 weeks
Patient Reported Outcome of Germline Genetic Testing based on GST Survey
Participants will complete the GST survey 1 (after the educational video and skin biopsy) and GST survey 2 between 45-60 days after disclosure of genetic test results. GST survey answers will be converted to a 5-point scale: 1- Disagree strongly, 2-Disagree, 3-Neither Agree or Disagree, 4-Agree, 5- Agree strongly.
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
NCCN guideline-based eligibility for germline genetic testing will be assessed using the following criteria and manual review of participants' medical record, 1) Participants with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) less than age 50, 2) Hypoplastic MDS regardless of age; 3) History of aplastic anemia, 4) Documented suspicion of a possible germline predisposition to myeloid malignancies.
Time frame: Up to 12 weeks
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
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