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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Genetic
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 30
Healthy Volunteers: f
View:

• 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)

Locations
United States
Connecticut
Connecticut Children's Medical Center
RECRUITING
Hartford
Massachusetts
Boston Children's Hospital
ACTIVE_NOT_RECRUITING
Boston
Dana Farber Cancer Institute
ACTIVE_NOT_RECRUITING
Boston
Maine
Maine Medical Center
RECRUITING
Portland
New Hampshire
Dartmouth-Hitchcock
RECRUITING
Lebanon
New York
Albany Medical Center
RECRUITING
Albany
Rhode Island
Lifespan Cancer Institute
RECRUITING
Providence
Vermont
University of Vermont Medical Center
RECRUITING
Burlington
Contact Information
Primary
Yana Pikman, MD
yana_pikman@dfci.harvard.edu
(617) 632-4754
Time Frame
Start Date: 2021-06-11
Estimated Completion Date: 2033-06
Participants
Target number of participants: 300
Treatments
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
Sponsors
Collaborators: Charles H. Hood Foundation, Rally Foundation for Childhood Cancer Research
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov