Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06870760

Conditions

Clonal Hematopoiesis of Indeterminate Potential

Monoclonal Gammopathy

Non Hodgkin Lymphoma

Leukemia

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 40 - 49

Healthy Volunteers: Accepted

Interventions

Monoclonal Gammopathy

Complete Blood Count with differential (CBC w/ diff)

Clonal hematopoiesis (CHIP)

Study Details

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

Clonal Hematopoiesis of Indeterminate Potential

Monoclonal Gammopathy

Non Hodgkin Lymphoma

Leukemia

Multiple Myeloma

Study ID

NCT06870760

Start date

Jun 23, 2026

Status verified date

Apr, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 49

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Monoclonal Gammopathy

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)

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)

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.

Primary outcome measure

  • Clonal Hematopoiesis (CHIP) [ Time Frame: From enrollment to availability of lab results, approximately 6 months ]

Central Contacts and Locations

Central contacts

Megan Lattanze

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

Locations

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Megan Lattanze

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

Principal Investigator:

Larry Druhan, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 13, 2026

Last verified

Apr, 2026

Keywords

  • Firefighters
  • CHIP
  • MGUS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-13.