Health TrialsbyHealthPanel

Pre-myeloid Cancer and Bone Marrow Failure Clinic Study

ConditionsMyeloid MalignancyInherited Bone Marrow Failure SyndromeClonal ExpansionCytopeniaBone Marrow Failure SyndromeClonal Cytopenia of Undetermined SignificanceClonal Hematopoiesis of Indeterminate PotentialHematologic NeoplasmsHematopoietic and Lymphatic System NeoplasmHereditary Neoplastic SyndromeIdiopathic Cytopenia of Undetermined SignificanceIdiopathic Dysplasia of Uncertain SignificanceLow Risk Myelodysplastic Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients under 18 years of age

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample, hair follicle, and saliva collection

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo a bone marrow biopsy

  • Punch Biopsy

    Procedure/Surgery

    Undergo a skin punch biopsy

  • Buccal Swab

    Procedure/Surgery

    Undergo a saliva or buccal swab

  • Clinical Evaluation

    Other intervention

    Undergo clinical assessment

  • Genetic Counseling

    Other intervention

    Receive genetic counseling

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Screening (biospecimen collection, NGS analysis)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Occurrence of cytopenias

Assessed by the number of subjects whose cytopenias are persistent or progressive over the course of the study

Time frame
Up tof 5 years

Secondary outcomes

1

Occurrence of myelodysplastic syndrome (MDS)

Assessed by the number of subjects who have evolved to MDS over the course of the study

Time frame
Up to 5 years
2

Occurrence of acute myeloid leukemia (AML)

Assessed by the number of subjects who have evolved to AML over the course of the study

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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