Clinical trial · Interventional
Pre-myeloid Cancer and Bone Marrow Failure Clinic Study
NCT02958462CI-TRIAL-00103830recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial tests next generation sequencing (NGS) for the detection of precursor features of pre-myeloid cancers and bone marrow failure syndromes. NGS is a procedure that looks at relevant cancer associated genes and what they do. Finding genetic markers for pre-malignant conditions may help identify patients who are at risk of pre-myeloid cancers and bone marrow failure syndromes and lead to earlier intervention.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Marrow Failure Syndrome | — | UNRESOLVED | — |
| Clonal Cytopenia of Undetermined Significance | — | UNRESOLVED | — |
| Clonal Expansion | — | UNRESOLVED | — |
| Clonal Hematopoiesis of Indeterminate Potential | — | UNRESOLVED | — |
| Cytopenia | — | UNRESOLVED | — |
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hematopoietic and Lymphatic System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hereditary Neoplastic Syndrome | — | UNRESOLVED | — |
| Idiopathic Cytopenia of Undetermined Significance | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Bone Marrow Biopsy | Procedure | — | UNRESOLVED |
| Buccal Swab | Procedure | — | UNRESOLVED |
| Clinical Evaluation | Other | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Genetic Counseling | Other | — | UNRESOLVED |
| Punch Biopsy | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening (biospecimen collection, NGS analysis)
- description
- Participants may undergo blood sample collection, a bone marrow biopsy, a skin punch biopsy, hair follicle collection, a buccal swab, and/or saliva collection for NGS analysis on study. Patients may additionally undergo clinical assessment and may receive genetic counseling on study.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Bone Marrow Biopsy
- Procedure: Punch Biopsy
- Procedure: Buccal Swab
- Other: Clinical Evaluation
- Other: Genetic Counseling
- Other: Quality-of-Life Assessment
- Other: Electronic Health Record Review
Primary outcomes (1)
- measure
- Occurrence of cytopenias
- timeFrame
- Up tof 5 years
- description
- Assessed by the number of subjects whose cytopenias are persistent or progressive over the course of the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with idiopathic cytopenias of unclear significance (ICUS) * Patients with clonal hematopoiesis of indeterminate significance (clonal hematopoiesis of indeterminate potential \[CHIP\]), including the recently described CHIP syndrome called VEXAS (vacuoles, E1 ubiquitin ligase, X chromosomal, autoimmune and somatic) * Patients with clonal cytopenias of undetermined significance (CCUS) * Marrow failure syndromes with myeloid malignancy predisposition - telomere dysfunction, chromosomal breakage disorders * Germ line inherited syndromes with risk for malignant transformation - GATA2, CEBPA, ETV-6, RUNX1, JAK2, PF6, etc. * Low risk MDS (idiopathic dysplasia of unclear significance) * Family member of a patient with one of the above conditions * Patient at high risk or suspected of developing one of the above conditions Exclusion Criteria: * Patients under 18 years of age
References
Publications (0)
Data not yet available
No reference posted for this study.