Pre-malignant States to Hematologic Malignancies in Firefighters
NCT ID: NCT06870760
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2026-03-31
2027-04-30
Brief Summary
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Detailed Description
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If clonal hematopoiesis (CHIP) results are interpreted by the investigator as abnormal, the participant will be given a clinical referral if indicated for discussion of diagnosis, potential further diagnostic tests, and implications per standard CHIP management guidelines. If monoclonal gammopathy or other (concerning) abnormality of the complete blood count is detected, the participant will be provided a referral for a clinic visit for diagnostic assessments and followed up per standard of care.
If the participant proceeds with the referral and diagnostic work-up, the final diagnosis (if any) resulting from the initial diagnostic assessment(s) will be collected
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Firefighter
Participants employed by the Charlotte Fire Department (CFD) with at least 5 years of on-the-job experience between the ages of 40 and 49
Monoclonal Gammopathy
Whole blood will be collected at the Baseline visit to evaluate for monoclonal gammopathy through SPEP, immunofixation, and free light chains.
Complete Blood Count with differential (CBC w/ diff)
Whole blood will be collected at the Baseline visit for CBC with differential which may inform a diagnosis of a plasma cell disorder or other hematological disorder.
Clonal hematopoiesis (CHIP)
Whole blood will be collected at the Baseline visit to be evaluated using next generation sequencing (NGS) detection of CHIP. Deep NGS to identify mutations associated with myeloid neoplasms and CHIP will be performed using an error-correcting next generation sequencing multi-gene panel targeting genes most frequently mutated in CHIP.
Interventions
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Monoclonal Gammopathy
Whole blood will be collected at the Baseline visit to evaluate for monoclonal gammopathy through SPEP, immunofixation, and free light chains.
Complete Blood Count with differential (CBC w/ diff)
Whole blood will be collected at the Baseline visit for CBC with differential which may inform a diagnosis of a plasma cell disorder or other hematological disorder.
Clonal hematopoiesis (CHIP)
Whole blood will be collected at the Baseline visit to be evaluated using next generation sequencing (NGS) detection of CHIP. Deep NGS to identify mutations associated with myeloid neoplasms and CHIP will be performed using an error-correcting next generation sequencing multi-gene panel targeting genes most frequently mutated in CHIP.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 40-49 years at the time of consent (self-reported)
3. Ability of the participant to understand and comply with study procedures for the entire length of the study
4. Currently employed by Charlotte Fire Department (CFD) with at least 5 years on-the -job experience (self-reported)
Exclusion Criteria
40 Years
49 Years
ALL
Yes
Sponsors
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Atrium Health Levine Cancer Institute
OTHER
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Larry Druhan, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Levine Cancer Institute
Charlotte, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LCI-LEU-FF-CHIP-001
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00124175
Identifier Type: -
Identifier Source: org_study_id
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