Clonal Hematopoiesis of Indeterminate PotentialNCT06870760
Pre-malignant States to Hematologic Malignancies in Firefighters
An observational study of Clonal Hematopoiesis of Indeterminate Potential and Monoclonal Gammopathy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Clonal Hematopoiesis of Indeterminate Potential, Monoclonal Gammopathy, Non Hodgkin Lymphoma
- What is being tested?
- Monoclonal Gammopathy, Complete Blood Count with differential (CBC w/ diff) and Clonal hematopoiesis (CHIP)
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2026to Apr 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
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)
Who may be able to join
- 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)
Who cannot join
- Anyone with a current diagnosis of a hematologic malignancy will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Megan Lattanze, 980-442-4239, Megan.Lattanze@advocatehealth.org
Larry Druhan, PhD
About this study
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.
Read the 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
- Conditions
- Clonal Hematopoiesis of Indeterminate Potential, Monoclonal Gammopathy, Non Hodgkin Lymphoma, Leukemia, Multiple Myeloma, Plasma Cell Disorder
- Being tested
- Monoclonal Gammopathy, Complete Blood Count with differential (CBC w/ diff), Clonal hematopoiesis (CHIP)
- Keywords
- Firefighters, CHIP, MGUS
- Medical subject headings
- Paraproteinemias, Lymphoma, Non-Hodgkin, Leukemia, Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monoclonal GammopathyOther
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
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Monoclonal Gammopathy; Other: Complete Blood Count with differential (CBC w/ diff); Other: Clonal hematopoiesis (CHIP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to availability of lab results, approximately 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start23 Jun 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clonal Hematopoiesis of Indeterminate PotentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Larry Druhan, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870760
- Sponsor's protocol ID
- IRB00124175
- Other IDs
- LCI-LEU-FF-CHIP-001
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No