Pre-malignant States to Hematologic Malignancies in Firefighters

April 13, 2026 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute
        • Principal Investigator:
          • Larry Druhan, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Monoclonal Gammopathy
Whole blood will be collected at the Baseline visit to evaluate for monoclonal gammopathy through SPEP, immunofixation, and free light chains.
Other: Complete Blood Count with differential (CBC w/ diff)
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.
Other: Clonal hematopoiesis (CHIP)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to availability of lab results, approximately 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monoclonal Gammopathy (MGUS)
Time Frame: From enrollment to availability of lab results, approximately 1 week
The presence of monoclonal gammopathy will be determined for each enrolled participant as a binary variable defined as abnormal SPEP, IFE, or FLC result.
From enrollment to availability of lab results, approximately 1 week
Targeted Diagnoses Rate
Time Frame: up to 12 months after all labs have resulted
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.
up to 12 months after all labs have resulted
Baseline Survey Results
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Atrium Health Levine Cancer Institute

Investigators

  • Principal Investigator: Larry Druhan, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00124175
  • LCI-LEU-FF-CHIP-001 (Other Identifier: Atrium Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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