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.
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 Type
OBSERVATIONAL
Enrollment
300
Whole blood will be collected at the Baseline visit to evaluate for monoclonal gammopathy through SPEP, immunofixation, and free light chains.
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.
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.
Levine Cancer Institute
Charlotte, North Carolina, United States
RECRUITINGClonal 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.
Time frame: From enrollment to availability of lab results, approximately 6 months
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.
Time frame: From enrollment to availability of lab results, approximately 1 week
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.
Time frame: up to 12 months after all labs have resulted
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.
Time frame: Baseline
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