跳至主要内容
临床试验/NCT05738031
NCT05738031撤回不适用

Investigating Incidental Pulmonary Nodules in Underserved Communities

Montefiore Medical Center1 个研究点 分布在 1 个国家开始时间: 2023年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Capture of incidentally identified lung nodules utilizing the electronic medical record

研究概览

简要总结

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.

详细描述

An estimated 235,760 people will be newly diagnosed with lung cancer in 2021 and over 130,000 people will die as a result. Computed tomography (CT) screening has demonstrated reduced lung cancer mortality, and is now recommended for adults aged 50 to 80 years with a 20-pack-year smoking history who are current smoker or have quit within 15 years. Along with the early identification of at-risk pulmonary nodules, screening programs also have the ability to direct patients into pathways for protocolized follow-up. Despite defined eligibility requirements, lung cancer screening (LCS) is underutilized, with less than 10% of eligible patients undergoing screening. Screening is particularly challenging in minority and socioeconomically disadvantaged populations, who face an increased risk of death due to lung cancer. Of over 50,000 patients enrolled in the National Lung Screening Trial, for example, only 4.5% of participants identified as Black and 1.7% identified as Hispanic.

Outside of screening programs, lung nodules are commonly detected incidentally on imaging done for other reasons. Each year, more than 1.5 million patients are diagnosed with an incidental pulmonary nodule. Of these, 5-9% are estimated to represent cancers, higher than the malignancy rate noted in lung cancer screening programs. Guidelines exist for the follow-up of IPNs, however compliance is often poor. IPNs may be overlooked in the context of the other illnesses for which imaging is obtained. Tests may also be ordered by providers without continuity of care, as occurs in the emergency department (ED). Patients may thus be unaware of incidental findings or receive inadequate direction for follow-up when there is no clear chain of responsibility. Racially disparate populations are specifically at risk and often face barriers to accessing primary care providers (PCPs), leading to increased use of the ED. In one study, a higher proportion of Black and Hispanic patients (38.3% and 28.1%, respectively) had initial imaging identifying an IPN performed in the ED compared to White patients (10.7%), who were more likely to have outpatient scans.

Previous studies indicate that only 38% of patients receive guideline concordant care once diagnosed with an IPN. Lung cancer was diagnosed in 8% of these patients undergoing such care compared to only 1% in those who received less intensive evaluation. Similarly, the median time to diagnosis of a lung cancer was 1.3 months in the guideline concordant care group versus 12 months in the less intensive evaluation patients, again underscoring the importance of appropriate mechanisms of follow-up. The consequences of a missed nodule are clear.

Data suggest that racial and ethnic disparities exist in the follow-up of IPNs. In a study of 1,562 patients with an IPN requiring follow-up at a tertiary care center, only 49.1% of Hispanic patients and 55.1% of Black patients were notified of IPNs compared to 79.5% of White patients. Similarly, non-White patients had significantly lower rates of ordering and adherence to follow-up imaging and had an increased odds of delaying follow-up. While this discrepancy in care has been identified, few solutions exist to bridge the gap and underrepresented patients remain at higher risk of delayed diagnosis until advanced stages of disease.

Further compounding the difficulty in managing underserved patients with IPNs is the lack of programs for formalized follow-up, specifically in urban areas. In an advisory board meeting of major medical centers within New York City, only one formal nodule evaluation program associated with a center's ED was identified. New York Presbyterian Hospital Weill Cornell identified 539 patients with IPNs over a two-year period. After radiologic review, chest radiologists referred 289 patients for further consultation and of these 142 (26.3% of original population) were referred for evaluation by a pulmonologist or oncologist. While the results of this investigation and rates of cancer diagnoses are currently being tabulated, the large proportion of patients referred for concerning findings is quite notable.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • <18 years of age
  • No evidence of a lung nodule through imaging

结局指标

主要结局

Capture of incidentally identified lung nodules utilizing the electronic medical record

时间窗: Through completion of chart review, up to 1 year

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.

Performance comparison of EMR-based algorithm to establish risk

时间窗: Through development of algorithm, up to 1 year

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.

Evaluation of LiquidLung plasma-based gene expression assay for biomarker subset selection using biobanked specimens

时间窗: Through evaluation of assay, up to 1.5 years

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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