Genomic profiling of blood and bone marrow samples from children and young adults with blood cancers
Protocol For Genomically Profiling, Collecting, Archiving And Distributing Blood And Bone Marrow Specimens From Children And Young Adults With Hematologic Malignancy
This study is testing how analyzing the genes in blood and bone marrow samples from kids and young adults with blood cancers can help doctors make better treatment decisions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | N/A to 30 Years |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 8 sites (Hartford, Connecticut and 7 other locations) |
| Trial ID | NCT04968834 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on genomic profiling and the collection of blood and bone marrow specimens from pediatric patients diagnosed with leukemia, myelodysplastic syndromes, or myeloproliferative syndromes. Participants will have their samples analyzed to understand the genetic factors contributing to their diseases, which may influence treatment decisions. The study aims to enroll approximately 100 patients annually across eight medical centers in the United States, utilizing samples obtained during clinical procedures. The genomic data collected will be shared with treating oncologists to potentially guide therapy.
Who should consider this trial
Good fit: Ideal candidates include children and young adults under 30 years old with newly diagnosed or relapsed/refractory leukemia or related syndromes.
Not a fit: Patients without sufficient specimens for genomic profiling or those not undergoing planned clinical evaluations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for children and young adults with hematologic malignancies.
How similar studies have performed: Other studies utilizing genomic profiling in hematologic malignancies have shown promise, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hartford, Connecticut and 7 other locations
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (Recruiting)
- Maine Medical Center — Portland, Maine, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Active_not_recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Active_not_recruiting)
- Dartmouth-Hitchcock — Lebanon, New Hampshire, United States (Recruiting)
- Albany Medical Center — Albany, New York, United States (Recruiting)
- Lifespan Cancer Institute — Providence, Rhode Island, United States (Recruiting)
- University of Vermont Medical Center — Burlington, Vermont, United States (Recruiting)
Study contacts
- Principal investigator: Yana Pikman, MD — Dana-Farber Cancer Institute
- Study coordinator: Yana Pikman, MD
- Email: yana_pikman@dfci.harvard.edu
- Phone: (617) 632-4754
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.