RecruitingRecruiting
Genomically Profiling, Collecting, Archiving and Distributing Hematologic Malignancy Specimens
NCT04968834 · Dana-Farber Cancer Institute
In plain English
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Official title
Protocol For Genomically Profiling, Collecting, Archiving and Distributing Blood and Bone Marrow Specimens From Children and Young Adults With Hematologic Malignancy
About this study
Pediatric patients with new diagnosis or relapsed/refractory acute leukemia, MDS/AML, chronic leukemia, myeloproliferative syndromes or myelodysplastic syndrome will be enrolled onto this study. At the time of enrollment, a sample of the leukemia will be submitted for genomic profiling using CLIA assay(s). This information will be returned to the treating oncologist. The study will collect follow up data on patient outcome and whether the genomic profiling influenced treatment.
It is expected that about 100 people each year will take part in this research study at 8 medical centers in the United States
Eligibility criteria
Inclusion Criteria:
* Age: birth to \< 30 years of age
* Diagnosis:
\-- Patient with acute leukemia, chronic leukemia, MDS/AML, myelodysplastic syndrome or myeloproliferative syndromes. Disease can be newly diagnosed or relapsed/refractory.
* Pathology Criteria:
\-- Histologic confirmation of leukemia or myelodysplastic syndrome (MDS) or myeloproliferative syndrome (MPS) at the time of diagnosis or recurrence
* Specimen Criteria:
* Sufficient sample available for genomic profiling OR bone marrow aspirate/blood draw planned for clinical care which is anticipated to allow collection of minimum specimen for testing (See Section 6.1 for description of specimen requirements)
Exclusion Criteria:
\- Insufficient leukemia or MDS specimen available for profiling from diagnosis or recurrence (See Section 6.1); or bone marrow evaluations NOT planned for clinical care; or peripheral blast percentage \<20%, or clinical blood draw not planned
Study design
Enrollment target: 300 participants
Age groups: child, adult
Timeline
Starts: 2021-06-11
Estimated completion: 2033-06
Last updated: 2026-07-16
Interventions
Genetic: Genomic profiling
Primary outcomes
- • Number of Patients Enrolled for Genomic Profiling-Pediatric Leukemia (3 Years)
Sponsor
Dana-Farber Cancer Institute · other
With: Charles H. Hood Foundation, Rally Foundation for Childhood Cancer Research
Contacts & investigators
ContactYana Pikman, MD · contact · yana_pikman@dfci.harvard.edu · (617) 632-4754
InvestigatorYana Pikman, MD · principal_investigator, Dana-Farber Cancer Institute
All locations (8)
Connecticut Children's Medical CenterRecruiting
Hartford, Connecticut, United States
Maine Medical CenterRecruiting
Portland, Maine, United States
Boston Children's HospitalActive Not Recruiting
Boston, Massachusetts, United States
Dana Farber Cancer InstituteActive Not Recruiting
Boston, Massachusetts, United States
Dartmouth-HitchcockRecruiting
Lebanon, New Hampshire, United States
Albany Medical CenterRecruiting
Albany, New York, United States
Lifespan Cancer InstituteRecruiting
Providence, Rhode Island, United States
University of Vermont Medical CenterRecruiting
Burlington, Vermont, United States