Genomically Profiling, Collecting, Archiving and Distributing Hematologic Malignancy Specimens

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 30
SponsorDana-Farber Cancer Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age: birth to < 30 years of age

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)

Disqualifiers

None

Trial population

\- birth to \< 30 years of age. Patient with acute leukemia, chronic leukemia, MDS/AML, myelodysplastic syndrome or myeloproliferative syndromes. Disease can be newly diagnosed or relapsed/refractory.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Genomic profiling

    Genetic

    Genomic profiling using CLIA assay

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: GENOMIC PROFILING AND SPECIMEN BANKING REGISTRATION ARM1 intervention

Trial outcomes

Primary outcomes

1

Number of Patients Enrolled for Genomic Profiling-Pediatric Leukemia

To perform genomic profiling of pediatric leukemia using clinical genomics platforms and return results to treating oncologist. This objective will be accomplished by enrolling patients and obtaining samples for sequencing and banking. The pathologist-interpreted genomic test results will be returned to the treating oncologist.

Time frame
3 Years

Secondary outcomes

1

Number of Patients Enrolled for Genomic Profiling-New Diagnosis

To collect and bank samples from pediatric patients with new diagnosis or relapsed/refractory acute and chronic leukemia, and myelodysplastic syndrome. This objective will be accomplished by enrolling patients and obtaining samples for sequencing and banking.

Time frame
3 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Charles H. Hood Foundation

Collaborator

Rally Foundation for Childhood Cancer Research

Collaborator