NCT04968834 Genomically Profiling, Collecting, Archiving and Distributing Hematologic Malignancy Specimens
| NCT ID | NCT04968834 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-06-11 |
| Primary Completion | 2033-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2021-06-11 with a primary completion date of 2033-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Yana Pikman, MD
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT04968834 clinical trial?
This trial is open to participants of all sexes, up to 30 Years, studying Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04968834 currently recruiting?
Yes, NCT04968834 is actively recruiting participants. Contact the research team at yana_pikman@dfci.harvard.edu for enrollment information.
Where is the NCT04968834 trial being conducted?
This trial is being conducted at Hartford, United States, Portland, United States, Boston, United States, Boston, United States and 4 additional locations.
Who is sponsoring the NCT04968834 clinical trial?
NCT04968834 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Yana Pikman, MD at Dana-Farber Cancer Institute. The trial plans to enroll 300 participants.
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