Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,000

participants targeted

Target at P75+ for not_applicable

Timeline

114mo left

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach

1 country

3 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

18.7 years study duration

Study Progress50%

Jan 2017Sep 2035

First Submitted

Initial submission to the registry

November 4, 2016

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed

2 months until next milestone

Study Start

First participant enrolled

January 16, 2017

Completed

13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2030

Expected

5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2035

Last Updated

February 23, 2026

Status Verified

March 1, 2025

Enrollment Period

13.7 years

First QC Date

November 4, 2016

Last Update Submit

February 20, 2026

Conditions

Hereditary Neoplastic Syndrome Low Risk Myelodysplastic Syndrome Myeloid Malignancy Inherited Bone Marrow Failure Syndrome Clonal Expansion Cytopenia Bone Marrow Failure Syndrome Clonal Cytopenia of Undetermined Significance Clonal Hematopoiesis of Indeterminate Potential Hematologic Neoplasms Hematopoietic and Lymphatic System Neoplasm Idiopathic Cytopenia of Undetermined Significance Idiopathic Dysplasia of Uncertain Significance

Outcome Measures

Primary Outcomes (1)

Occurrence of cytopenias
Assessed by the number of subjects whose cytopenias are persistent or progressive over the course of the study
Up tof 5 years

Secondary Outcomes (2)

Occurrence of myelodysplastic syndrome (MDS)
Up to 5 years
Occurrence of acute myeloid leukemia (AML)
Up to 5 years

Study Arms (1)

Screening (biospecimen collection, NGS analysis)

EXPERIMENTAL

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.

Procedure: Biospecimen CollectionProcedure: Bone Marrow BiopsyProcedure: Punch BiopsyProcedure: Buccal SwabOther: Clinical EvaluationOther: Genetic CounselingOther: Quality-of-Life AssessmentOther: Electronic Health Record Review