Clinical trial NCT06870760: Pre-malignant States to Hematologic Malignancies in Firefighters
Official title: Pre-malignant States to Hematologic Malignancies in Firefighters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clonal Hematopoiesis of Indeterminate Potential
Monoclonal Gammopathy
Non Hodgkin Lymphoma
Leukemia
Multiple Myeloma
Plasma Cell Disorder
Keywords: Firefighters
CHIP
MGUS
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
First posted: 2025-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Firefighters ages 40-49 years old, currently employed by Charlotte Fire Department (CFD) with at least 5 years on the job experience (self-reported)

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

Eligibility criteria: Inclusion Criteria:

1. Written informed consent and HIPAA authorization for release of personal health information.
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:

Anyone with a current diagnosis of a hematologic malignancy will be excluded.

Primary outcomes:
measure: Clonal Hematopoiesis (CHIP)
timeFrame: From enrollment to availability of lab results, approximately 6 months
Secondary outcomes:
measure: Monoclonal Gammopathy (MGUS)
timeFrame: From enrollment to availability of lab results, approximately 1 week
measure: Targeted Diagnoses Rate
timeFrame: up to 12 months after all labs have resulted
measure: Baseline Survey Results
timeFrame: Baseline
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Larry Druhan, PhD
role: PRINCIPAL_INVESTIGATOR
References: