Leukemia Clinical Trial
Official title:
Protocol For Genomically Profiling, Collecting, Archiving And Distributing Blood And Bone Marrow Specimens From Children And Young Adults With Hematologic Malignancy
NCT number | NCT04968834 |
Other study ID # | 20-302 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 11, 2021 |
Est. completion date | June 2033 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 2033 |
Est. primary completion date | June 2033 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 30 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Albany Medical Center | Albany | New York |
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | University of Vermont Medical Center | Burlington | Vermont |
United States | Connecticut Children's Medical Center | Hartford | Connecticut |
United States | Dartmouth-Hitchcock | Lebanon | New Hampshire |
United States | Maine Medical Center | Portland | Maine |
United States | Lifespan Cancer Institute | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Charles H. Hood Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3 Years | |
Secondary | 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. | 3 Years |
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