Clonal Hematopoiesis of Indeterminate Potential, Leukemia, Monoclonal Gammopathy, Multiple Myeloma, Non Hodgkin Lymphoma, Plasma Cell Disorder
Conditions
Keywords
Firefighters, CHIP, MGUS
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.
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
OTHERMonoclonal Gammopathy
Whole blood will be collected at the Baseline visit to evaluate for monoclonal gammopathy through SPEP, immunofixation, and free light chains.
OTHERComplete 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.
OTHERClonal 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.
Sponsors
Wake Forest University Health Sciences
Atrium Health Levine Cancer Institute
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 49 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clonal Hematopoiesis (CHIP) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monoclonal Gammopathy (MGUS) | 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. |
| Targeted Diagnoses Rate | 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. |
| Baseline Survey Results | 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. |
Countries
United States
Contacts
CONTACTMegan Lattanze
PRINCIPAL_INVESTIGATORLarry Druhan, PhD
Wake Forest University Health Sciences
Outcome results
None listed