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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of cytopenias

Secondary outcome measures

Occurrence of acute myeloid leukemia (AML)

Occurrence of myelodysplastic syndrome (MDS)

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 2

~10

Buccal Swab

2006

N/A

~1890

Biospecimen Collection

2004

Completed Phase 2

~1720

Punch Biopsy

2017

N/A

~40

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,233 Previous Clinical Trials

3,769,832 Total Patients Enrolled

Mrinal S. Patnaik, MBBS5.014 ReviewsPrincipal Investigator - Mayo Clinic

Mayo Clinic

Mrinal S Patnaik, MBBSPrincipal InvestigatorMayo Clinic

Media Library

Genomic Testing (Genomic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT02958462 — N/A

Myeloid Leukemia Research Study Groups: Screening (biospecimen collection, NGS analysis)

Myeloid Leukemia Clinical Trial 2023: Genomic Testing Highlights & Side Effects. Trial Name: NCT02958462 — N/A

Genomic Testing (Genomic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02958462 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are volunteers still being accepted for this research experiment?

"According to the clinicaltrials.gov portal, this trial is currently enrolling suitable candidates after being initially posted on November 1st 2016 and amended most recently on June 28th 2022."

Answered by AI

What is the size of the cohort involved in this clinical experiment?

"Correct. Accordingly, clinicaltrials.gov reports that this investigation is actively recruiting participants since it was first uploaded on November 1st 2016 and updated most recently on June 28th 2022. The trial seeks to recruit 1300 individuals from one centre of research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pre-myeloid Cancer and Bone Marrow Failure Clinic Study

Mrinal S. Patnaik, M.B.B.S. 2017. "Pre-myeloid Cancer and Bone Marrow Failure Clinic Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02958462.

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