Pre-malignant States to Hematologic Malignancies in Firefighters
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Clonal Hematopoiesis (CHIP)
Study Overview
Brief Summary
The purpose of the study is to evaluate if firefighter exposure to hazardous compounds will increase the incidence of premalignant hematological states which subsequently increases the risk of the development of hematologic malignancies, and potentially other pathophysiological consequences.
Detailed Description
Firefighters from the Charlotte Fire Department, ages 40-49 and with at least 5 years on the job experience will be offered consent for this study. Consented and eligible participants will have labs collected at the Baseline visit to evaluate for CHIP and monoclonal gammopathy. Buccal swabs (also collected at Baseline) and any remaining blood from the Baseline labs will be collected from participants who consent to collection and banking of their samples for future research. Participants will also complete the Firefighter History Assessment at Baseline.
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 40 Years to 49 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Written informed consent and HIPAA authorization for release of personal health information.
- •Age ≥ 40-49 years at the time of consent (self-reported)
- •Ability of the participant to understand and comply with study procedures for the entire length of the study
- •Currently employed by Charlotte Fire Department (CFD) with at least 5 years on-the -job experience (self-reported)
Exclusion Criteria
- •Anyone with a current diagnosis of a hematologic malignancy will be excluded.
Arms & Interventions
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
Intervention: Monoclonal Gammopathy (Other)
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
Intervention: Complete Blood Count with differential (CBC w/ diff) (Other)
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
Intervention: Clonal hematopoiesis (CHIP) (Other)
Outcomes
Primary Outcomes
Clonal Hematopoiesis (CHIP)
Time Frame: From enrollment to availability of lab results, approximately 6 months
The presence of positive somatic mutation will be determined for each enrolled participant as a binary variable indicating if the participant is harboring clonal hematopoiesis.
Secondary Outcomes
- Monoclonal Gammopathy (MGUS)(From enrollment to availability of lab results, approximately 1 week)
- Targeted Diagnoses Rate(up to 12 months after all labs have resulted)
- Baseline Survey Results(Baseline)