RecruitingNCT04968834

Protocol For Genomically Profiling, Collecting, Archiving And Distributing Blood And Bone Marrow Specimens From Children And Young Adults With Hematologic Malignancy


Sponsor

Dana-Farber Cancer Institute

Enrollment

300 participants

Start Date

Jun 11, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

This research study is a genomic profiling and repository study for children and young adults who have leukemia, myelodysplastic syndrome (MDS) or myeloproliferative syndrome (MPS). Genes are the part of cells that contain the instructions which tell cells how to make the right proteins to grow and work. Genes are composed of DNA letters that spell out these instructions. Genomic profiling helps investigators understand why the disease develops and the instructions that led to its development. Understanding the genetic factors of the disease can also help investigator understand why the disease of some people can respond to certain therapies differently than others. The genomic profiling will be performed using bone marrow and blood samples that either have already been obtained during a previous clinical procedure or will be obtained at the time of a scheduled clinical procedure. Studying the genetic information in the cells of these samples will provide information about the origin, progression, and treatment of leukemia and myeloproliferative syndromes and myelodysplastic syndrome. Storing the bone marrow and blood samples will allow for additional research and genomic assessments to be performed in the future.


Eligibility

Max Age: 30 Years

Inclusion Criteria7

  • 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 Criteria1

  • \- 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

Interventions

GENETICGenomic profiling

Genomic profiling using CLIA assay


Locations(8)

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Maine Medical Center

Portland, Maine, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Dartmouth-Hitchcock

Lebanon, New Hampshire, United States

Albany Medical Center

Albany, New York, United States

Lifespan Cancer Institute

Providence, Rhode Island, United States

University of Vermont Medical Center

Burlington, Vermont, United States

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NCT04968834


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