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 — GENETICGenomic 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 ARMThe 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
- Yana Pikman, MD(617) 632-4754
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | Natalie Bezler, MD |
| Maine Medical Center | Portland | Maine | 04102 | Sei Sze, MD |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | - |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
| Dartmouth-Hitchcock | Lebanon | New Hampshire | 03756 | Angela Ricci, MD |
| Albany Medical Center | Albany | New York | 12208 | Jessica Geaney, MD |
| Lifespan Cancer Institute | Providence | Rhode Island | 02903 | Jennifer Welch, MD |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | Jessica Heath, MD |
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