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NCT05738031
Investigating Incidental Pulmonary Nodules in Underserved Communities
Conditions: Lung; Node
Sex: All
Ages: 18 Years – N/A
Enrollment: 250
Sponsor: Montefiore Medical Center
Location: United States
Summary
The study team hypothesizes that incidentally discovered pulmonary nodules are often under captured and/or not surveilled in accordance with published guidelines in the Montefiore Health System, which cares for a large proportion of Black and Hispanic patients.
Incidental Pulmonary Nodules (IPNs) require a pragmatic approach to follow-up and management, especially in racially disparate populations who have greater potential for lung cancer morbidity and mortality.
Eligibility Criteria
Inclusion Criteria:Part A of the study seeks to capture IPNs and standardize mechanism for management will employ the following inclusion criteria:Above the age of 18Underwent an imaging study for any purpose other than lung cancer screening at a Montefiore Medical Center facility that identifies a pulmonary noduleImaging results captured into the Epic electronic medical recordReferred to the lung nodule clinicUnderwent an in-person or telephone/telehealth encounter at a Montefiore Medical Center facility during the study periodLung cancers diagnosed at a Montefiore Medical Center facility between April 1, 2021 and March 31 2022 will also be included for retrospective review and comparison to the cohort of lung cancers diagnosed following the instillation of the IPN program herein describedPart B of the study will seek to develop an algorithm for incidental lung nodule risk stratification utilizing data from the electronic medical record.
Inclusion criteria are:Above the age of 18Underwent an imaging study for any purpose other than lung cancer screening at a Montefiore Medical Center facility that identifies a pulmonary noduleImaging results captured into the Epic electronic medical recordReferred to the lung nodule clinicUnderwent an in-person or telephone/telehealth encounter at a Montefiore Medical Center facility during the study periodThe third part (Part C) of the study is a substudy examining plasma-based expression of markers associated with lung cancer in patients with lung nodules, and will include the following patients:Above the age of 18Underwent an imaging study, including imaging performed for lung cancer screening, at a Montefiore Medical Center facility that identifies a pulmonary noduleImaging results captured into the Epic electronic medical recordReferred to the lung nodule clinicUnderwent an in-person or telephone/telehealth encounter at a Montefiore Medical Center facility during the study periodRecommended follow-up by means of either continued imaging surveillance of nodule or procedure for diagnosis, including percutaneous transthoracic needle biopsy, endobronchial transbronchial needle aspiration, surgical biopsy or resection of pulmonary noduleExclusion Criteria:<18 years of ageNo evidence of a lung nodule through imaging
Source: ClinicalTrials.gov (NCT05738031). StuddyBuddy aggregates publicly available trial information.