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Trial Title:
MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies
NCT ID:
NCT06543511
Condition:
Myeloid Malignancy
Myeloid Malignancies
Blood Cancer
Blood Cancers
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Disease Susceptibility
Conditions: Keywords:
Myeloid Malignancy
Myeloid Malignancies
Blood Cancer
Blood Cancers
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Genetic Blood Test
Description:
Germline genetic testing using skin fibroblasts
Arm group label:
Germline Genetic Testing
Other name:
Custom Hereditary Cancer Gene Panel
Summary:
This research study is evaluating the feasibility of conducting cancer genetic testing
using healthy skin cells among participants with a diagnosis of a blood cancer.
Additionally, investigators will evaluate how often participants with blood cancers are
found to have risk for cancer based on family genes.
Detailed description:
The purpose of this prospective, non-randomized, non-therapeutic, single arm study is to
determine the feasibility and benefit of performing genetic testing for all participants
with a blood cancer diagnosis regardless of clinical suspicion.
Research study procedures include screening for eligibility, in-clinic visits,
questionnaires, and skin punch biopsies. Participants will receive germline genetic
testing with a comprehensive hereditary cancer gene panel.
It is expected that about 200 individuals with blood cancer will take part in this
research study.
Criteria for 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
or Spanish.
Exclusion Criteria:
- Patients with who cannot safely undergo skin biopsy as adjudicated by the study
team.
- Patients who have previously undergone germline genetic testing for predisposition
to myeloid malignancies
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02215
Country:
United States
Contact:
Last name:
Christopher Reilly, MD
Phone:
407-443-6243
Email:
christopherr_reilly@dfci.harvard.edu
Investigator:
Last name:
Christopher Reilly, MD
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Contact:
Last name:
Christopher Reilly, MD
Phone:
407-443-6243
Email:
christopherr_reilly@dfci.harvard.edu
Investigator:
Last name:
Christopher Reilly, MD
Email:
Principal Investigator
Start date:
October 2024
Completion date:
July 1, 2029
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06543511
