Lung; Node Clinical Trial
Official title:
Investigating Incidental Pulmonary Nodules in Underserved Communities
NCT number | NCT05738031 |
Other study ID # | 2021-13475 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | October 2023 |
Est. completion date | May 2025 |
Verified date | November 2023 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 18 - Underwent an imaging study for any purpose other than lung cancer screening at a Montefiore Medical Center facility that identifies a pulmonary nodule - Imaging results captured into the Epic electronic medical record - Referred to the lung nodule clinic - Underwent an in-person or telephone/telehealth encounter at a Montefiore Medical Center facility during the study period - Lung 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 described Part 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 18 - Underwent an imaging study for any purpose other than lung cancer screening at a Montefiore Medical Center facility that identifies a pulmonary nodule - Imaging results captured into the Epic electronic medical record - Referred to the lung nodule clinic - Underwent an in-person or telephone/telehealth encounter at a Montefiore Medical Center facility during the study period The 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 18 - Underwent an imaging study, including imaging performed for lung cancer screening, at a Montefiore Medical Center facility that identifies a pulmonary nodule - Imaging results captured into the Epic electronic medical record - Referred to the lung nodule clinic - Underwent an in-person or telephone/telehealth encounter at a Montefiore Medical Center facility during the study period - Recommended 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 nodule Exclusion Criteria: - <18 years of age - No evidence of a lung nodule through imaging |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center-Albert Einstein College of Medicine | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Performance of LiquidLung plasma-based gene expression assay on patients with incidental or screen-detected lung nodules | As an exploratory aim, the performance (utility/feasibility) of the LiquidLung assay will be assessed in patients enrolled into Montefiore's lung nodule clinic for the ability of the assay to classify incidental or screen-detected lung nodules as benign or malignant. | Through evaluation of assay performance, up to 1.5 years | |
Primary | Capture of incidentally identified lung nodules utilizing the electronic medical record | To capture all incidentally identified lung nodules and create a multidisciplinary team for lung nodule management. Radiology and pulmonary providers will identify and report IPNs >=6mm denoted as positive imaging result at Montefiore. NLP will be used to identify IPNs using the Lung Orchestrator and IPNs will be captured by automated assessment of radiology. Cardiothoracic Imaging will assist in nodule identification using NLP. Following confirmation of a nodule requiring follow-up, the Lung Orchestrator will place the patient in a work queue. Patients diagnosed with lung cancer the year prior to the program will be reviewed retrospectively with NLP for determination on whether the approach increases adherence to IPN follow-up guidelines. | Through completion of chart review, up to 1 year | |
Primary | Performance comparison of EMR-based algorithm to establish risk | Patients will be followed to develop a multi-component integrated risk classifier for stratification into low or intermediate malignancy risk. Risk calculators (Brock University; Mayo Clinic) will be used for assessment and evaluations designed to automatically populate in the EMR. Stratification will be based upon demographic factors, such as age, gender, race, smoking, and cancer history. Imaging characteristics such as emphysema, nodule location, size, and concerning features will be used. The aim is to develop an automated risk calculating algorithm based upon AI-mediated processing of clinical data and radiomics. These assessments will allow for real-time risk identification and the investigation of a novel model will incorporate data from a more diverse population. | Through development of algorithm, up to 1 year | |
Primary | Evaluation of LiquidLung plasma-based gene expression assay for biomarker subset selection using biobanked specimens | This assay is applicable for all concerning pulmonary nodules, represented by those patients referred to the lung nodule clinic. The lung nodule clinic manages both incidental and screen-detected lesions. Montefiore Health System has an established lung cancer screening program with over 1,000 screenings completed in the last year. Patients with suspicious nodules are recommended follow-up and also have potential to benefit from testing via non-invasive means. | Through evaluation of assay, up to 1.5 years |
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