Pre-malignant States to Hematologic Malignancies in Firefighters

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-49
SponsorWake Forest University Health Sciences

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Monoclonal Gammopathy

    Other intervention

    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)

    Other intervention

    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)

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Firefighter3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to availability of lab results, approximately 6 months

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Atrium Health Levine Cancer Institute

Collaborator