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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04968834
Status
Recruiting

Conditions

  • Leukemia
  • Myelodysplastic Syndromes
  • Myeloproliferative Syndrome

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Genomic profiling — GENETIC
    Genomic profiling using CLIA assay

Study Details

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.

Key Dates

Start date
Jun 11, 2021
Status verified
Jun 2025
Primary completion
Jun 30, 2033
Completion
Jun 30, 2033

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: GENOMIC PROFILING AND SPECIMEN BANKING REGISTRATION ARM
    The research study procedures include screening for eligibility, reviewing and signing this consent form, collecting patient information and clinical data, obtaining previously collected bone marrow and blood samples, and completing a brief optional Household Survey. Bone marrow and blood samples may also be collected in the future as part of your routine clinical procedures

Primary Outcome Measure

Number of Patients Enrolled for Genomic Profiling-Pediatric Leukemia [ Time Frame: 3 Years ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Connecticut Children's Medical CenterHartfordConnecticut06106
Natalie Bezler, MD
Maine Medical CenterPortlandMaine04102
Boston Children's HospitalBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Dartmouth-HitchcockLebanonNew Hampshire03756
Angela Ricci, MD
Albany Medical CenterAlbanyNew York12208
Jessica Geaney, MD
Lifespan Cancer InstituteProvidenceRhode Island02903
Jennifer Welch, MD
University of Vermont Medical CenterBurlingtonVermont05401
Jessica Heath, MD

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