Pre-malignant States to Hematologic Malignancies in Firefighters

Обзор

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.

Подробное описание

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

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (3)

• Monoclonal Gammopathy (MGUS) [Срок оценки: From enrollment to availability of lab results, approximately 1 week]
• Targeted Diagnoses Rate [Срок оценки: up to 12 months after all labs have resulted]
• Baseline Survey Results [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Levine Cancer Institute — Charlotte

Идентификаторы

NCT: NCT06870760 · IRB00124175 · LCI-LEU-FF-CHIP-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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