Pre-malignant States to Hematologic Malignancies in Firefighters

NCT06870760 | Recruiting DMC

• 2 other identifiers: IRB00124175LCI-LEU-FF-CHIP-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Monoclonal Gammopathy; Non Hodgkin Lymphoma; Leukemia; Clonal Hematopoiesis of Indeterminate Potential; Multiple Myeloma; Plasma Cell Disorder

Keywords

Firefighters; CHIP; MGUS

Outcome Measures

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.

  From enrollment to availability of lab results, approximately 6 months

Secondary Outcomes (3)

• Monoclonal Gammopathy (MGUS)

  From enrollment to availability of lab results, approximately 1 week

• Targeted Diagnoses Rate

  up to 12 months after all labs have resulted

• Baseline Survey Results

  Baseline

Study Arms (1)

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; Other: Complete Blood Count with differential (CBC w/ diff); Other: Clonal hematopoiesis (CHIP)

Interventions

Monoclonal Gammopathy OTHER

Whole blood will be collected at the Baseline visit to evaluate for monoclonal gammopathy through SPEP, immunofixation, and free light chains.

Firefighter

Complete Blood Count with differential (CBC w/ diff) OTHER

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.

Firefighter

Clonal hematopoiesis (CHIP) OTHER

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.

Firefighter

Eligibility Criteria

• Age: 40 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swabs, whole blood

MeSH Terms

Conditions

Paraproteinemias; Lymphoma, Non-Hodgkin; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Blood Cell Count; Clonal Hematopoiesis; Chromatin Immunoprecipitation Sequencing

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Hematopoiesis; Cell Differentiation; Clonal Evolution; Genetic Phenomena; Chromatin Immunoprecipitation; Genetic Techniques; High-Throughput Nucleotide Sequencing; Sequence Analysis; Sequence Analysis, DNA; Immunoprecipitation; Immunologic Techniques

Study Officials

• Larry Druhan, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Lattanze

CONTACT

980-442-4239; Megan.Lattanze@advocatehealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)