About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
None
Trial 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)
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Monoclonal Gammopathy
Other interventionWhole 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)
Other interventionWhole 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)
Other interventionWhole 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.
Treatment groups
Trial outcomes
Primary outcomes
Clonal Hematopoiesis (CHIP)
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)
The presence of monoclonal gammopathy will be determined for each enrolled participant as a binary variable defined as abnormal SPEP, IFE, or FLC result.
Targeted Diagnoses Rate
The presence of a diagnosis(es) based off standard of care diagnostic assessment(s) will be determined for each enrolled participant and for each diagnosis. Targeted diagnoses: MGUS, Smoldering Multiple Myeloma, Multiple Myeloma, AL Amyloidosis, Other Plasma Cell Disorder, Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), Aplastic anemia, Clonal cytopenia of undetermined Significance (CCUS), and Other.
Baseline Survey Results
Baseline survey results will be summarized descriptively. The survey is an 18-item survey collecting data including: demographic information, personal and family health history, social behaviors, firefighting experience, prior history of cancer and other items related to firefighting experience. The survey question responses will be collected as either quantitative responses, nominal categorical responses, or ordered categorical responses.
Sponsors and contacts
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Wake Forest University Health Sciences
Lead sponsor
Atrium Health Levine Cancer Institute
Collaborator