Pre-malignant States to Hematologic Malignancies in Firefighters
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Monoclonal Gammopathy, Complete Blood Count with differential (CBC w/ diff), Clonal hematopoiesis (CHIP).
- Who it may be relevant to
- Registry conditions: Clonal Hematopoiesis of Indeterminate Potential, Monoclonal Gammopathy, Non Hodgkin Lymphoma, Leukemia. Basic parameters: 40 years — 49 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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
Interventions
- 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.
Primary outcome measures
- Clonal Hematopoiesis (CHIP) [Time frame: From enrollment to availability of lab results, approximately 6 months]
Secondary outcome measures (3)
- Monoclonal Gammopathy (MGUS) [Time frame: From enrollment to availability of lab results, approximately 1 week]
- Targeted Diagnoses Rate [Time frame: up to 12 months after all labs have resulted]
- Baseline Survey Results [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
Anyone with a current diagnosis of a hematologic malignancy will be excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Levine Cancer Institute — Charlotte
Identifiers
NCT: NCT06870760 · IRB00124175 · LCI-LEU-FF-CHIP-001