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Genomic Testing

Genomic Studies for Early Detection of Myeloid Leukemia or Bone Marrow Failure Syndrome

N/A

Recruiting

Led By Mrinal S. Patnaik, MBBS

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with Marrow failure syndromes with myeloid malignancy predisposition- telomere dysfunction, chromosomal breakage disorders, etc.

Patients with Idiopathic cytopenias of unclear significance (ICUS)

Must not have

Patients who are unable to understand and sign the Informed Consent Form

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses genomic and functional studies to identify patients with early signs of myeloid neoplasms or inherited bone marrow failure syndromes.

Who is the study for?

This study is for individuals with early signs of myeloid cancers or inherited bone marrow failure syndromes. It includes those with clonal hematopoiesis, age-related changes in blood cells, unclear cytopenias, and low-risk Myelodysplastic Syndromes. People who can't understand or sign the consent form are excluded.

What is being tested?

The trial is focused on monitoring patients using genomic studies to identify and diagnose precursor conditions to myeloid neoplasms and inherited bone marrow failures. There's no specific medication being tested; it's more about follow-up studies.

What are the potential side effects?

Since this trial involves follow-ups rather than direct interventions like medications or treatments, there are no typical side effects associated with drugs. However, participants may experience discomfort from routine medical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a bone marrow failure syndrome with a risk for blood cancer.

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I have been diagnosed with ICUS.

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I have a genetic condition that increases my cancer risk.

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I have been diagnosed with CHIP.

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I have been diagnosed with CCUS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able to understand and sign the Informed Consent Form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of cytopenias

Secondary study objectives

Occurrence of acute myeloid leukemia (AML)

Occurrence of myelodysplastic syndrome (MDS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Screening (biospecimen collection, NGS analysis)Experimental Treatment8 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Biopsy

2021

Completed Phase 3

~230

Punch Biopsy

2017

N/A

~40