Interstitial Lung DiseaseNCT04503044
ILAs in CT Lung Cancer Screening Population
An observational study of Interstitial Lung Disease and IPF, run by Lahey Clinic at 1 site in United States.
Trial summary
Interstitial Lung Abnormalities (ILA) have been previously defined as nondependent changes affecting more than 5% of any lung zone on computed tomography (CT) scans of the lung. Several studies suggest that the prevalence of ILA in participants in non-pulmonary research studies ranges anywhere from 7-9%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interstitial Lung Disease, IPF
- What is being tested?
- Retrospective observational study
- How many people
- 1,703 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2021to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All clinical CTLS patients at Lahey Hospital and Medical Center (LHMC), Burlington, MA from January 1st, 2012 through September 30th, 2014 who had an in network primary care physician (n=1703). Patients with T4 screening scans will be scored for progression (n=653). To qualify for our study, patients had to satisfy the National Comprehensive Cancer Network (NCCN) Guidelines® Lung Cancer Screening Version 1.2012 high-risk criteria for lung cancer. Based on the NCCN Guidelines®, individuals eligible for lung cancer screening can be classified into NCCN group 1 and 2 as previously described.21 Patients in both groups were asymptomatic and had a physician order for CTLS, were free of lung cancer for ≥ 5 years, and had no known metastatic disease.
Inclusion Criteria: Patient who have undergone low-dose screening CT scan for lung cancer as part of the LHMC CTLS program from January 1, 2012 through September 30, 2014, with an in-network PCP.
Exclusion Criteria: Any patient that does not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
About this study
Official title: Interstitial Lung Abnormalities--Qualitative Imaging Cohort Study in CT Lung Cancer Screening Population
Interstitial Lung Abnormalities (ILA) have been previously defined as nondependent changes affecting more than 5% of any lung zone on computed tomography (CT) scans of the lung. Several studies suggest that the prevalence of ILA in participants in non-pulmonary research studies ranges anywhere from 7-9%. Work over the last decade has shown that, despite previous characterization as an asymptomatic research finding, ILA has significant clinical and biological consequences. These include reduced exercise capacity, functional limitations, decreased lung volumes, increased mortality, and in some cases histopathology similar to Idiopathic Pulmonary Fibrosis (IPF). ILA have been detected in lung cancer screening cohorts, where the prevalence of ILA is estimated to be between (10%-20%) to those noted in other research cohorts. Given that a significant proportion of those will have progression, CT lung cancer screening (CTLS) cohorts represent an ideal catchment population for future research and clinical trials. Lahey Hospital and Medical Center was one of the earliest clinical centers to develop a CTLS program in the country. Investigators propose to qualitatively characterize ILA in a large clinical CTLS population.
Read the detailed description
Investigators propose a retrospective, single-center study with following aims:
- Characterize the prevalence and incidence of ILA at baseline and 5 year follow-up, respectively, and associated imaging phenotypes in CTLS cohort.
- Baseline qualitative ILA features associated with clinical outcomes: Lung Cancer, Hospitalization, and Mortality.
- Baseline qualitative ILA features associated with progressive ILA and fibrotic lung disease.
- Clinical opportunity: to determine the % of CTLS patients with ILA who are at risk for progressive and development of fibrotic lung disease and who would benefit from specialized care referral and potential enrollment in clinical trials utilizing proven antifibrotic therapies
Patient Selection:
All clinical CT Lung Cancer Screening (CTLS) patients at Lahey Hospital and Medical Center (LHMC), Burlington, MA from January 1st, 2012 through September 30th, 2014 who had an in network primary care physician (n=1703). Patients with T4 screening scans will be scored for progression (n=653). To qualify for our study, patients had to satisfy the National Comprehensive Cancer Network (NCCN) Guidelines® Lung Cancer Screening Version 1.2012 high-risk criteria for lung cancer. Based on the NCCN Guidelines®, individuals eligible for lung cancer screening can be classified into NCCN group 1 and 2 as previously described. Patients in both groups were asymptomatic and had a physician order for CTLS, were free of lung cancer for ≥ 5 years, and had no known metastatic disease.
Clinical Variables:
Clinical variables were collected prospectively as part of the CTLS program and stored in a centralized data repository. Additional clinical variables not already available in this data repository will be collected retrospectively by manual review of the electronic medical record or pulled directly from the EMR and stored utilizing a custom-designed database (FileMaker ProVersion 11; Filemaker Inc, Santa Clara, California). Data was obtained through September 30th, 2019, patient demographics, past medical history, PFTs, immunization records, whether the patient was managed by a pulmonologist, and for hospital admissions with principal admission diagnoses. Hospital admissions will be collected using Lahey administrative coding data. Principal admission diagnoses of COPD, PNA, and CHF will be characterized based on diagnosis codes per 2018 Center for Medicare and Medicaid Services (CMS) condition-specific measures.
CT Imaging:
Clinically acquired, CTLS examinations which were performed on ≥64-row multidetector CT scanners (LightSpeed VCT and Discovery VCT [GE Medical Systems, Milwaukee, Wisconsin]; Somatom Definition [Siemens AG, Erlangen, Germany]; iCT [Philips Medical Systems, Andover, Massachusetts]) at 100 kV and 30 to 100 mA, depending on the scanner and the availability of iterative reconstruction software. Axial images were obtained at 1.25- to 1.5-mm thickness with 50% overlap and reconstructed with both soft tissue and lung kernels.
Qualitative ILA Scoring:
CT images will be scored utilizing Philips Intellispace PACS version 4.4 with clinical grade monitors. Scoring will be performed independently by two thoracic radiologists as described previously. Scores that are discordant between the two radiologists will be scored by a third by a pulmonologist with expertise in ILD.
ILA: The presence of ILA features will be scores as (Yes/No/Indeterminate). Indeterminate will be defined as features identified unilaterally/focal involvement.
ILA features that will be scored include: A) non dependent ground glass, B) reticular abnormalities, C) traction bronchiectasis and D) honeycombing.
- Non Dependent ground glass: (Yes/No/Indeterminate) defined as hazy increased attenuation of the lung with preservation of bronchial and vascular margins.
- Reticular abnormalities: (Yes/No/Indeterminate) defined as a collection of innumerable small linear opacities that, by summation, produce an appearance resembling a net.
- Traction Bronchiectasis: (Yes/No/Indeterminate) defined Traction bronchiectasis and traction bronchiolectasis respectively represents irregular bronchial and bronchiolar dilatation caused by surrounding retractile pulmonary fibrosis.
- Honeycombing: (Yes/No/Indeterminate) defined on CT as clustered cystic air spaces, typically of comparable diameters on the ordered of 3-10 mm but occasionally as large as 2.5 cm.
Pattern: The overall pattern/Type of ILA findings will also be scored as the following: Subpleural, centrilobular, mixed or consistent with ILD (see UIP below).
Subpleural: Defined as less than 1 cm from the pleural surface.
Centrilobular: Defined as region of the bronchiolovascular core of the secondary pulmonary lobule.
Location: Overall location ILA will then be scored as Upper lobe, lower lobe or diffuse.
Extent: Overall extent of disease will be scored as Mild, Moderate and Marked.
Usual Interstitial Pneumonia: Finally, the subset of scans that have evidence of fibrotic disease defined as traction bronchiectasis/honeycombing will then be classified as consistent with usual interstitial pneumonia (UIP) (Yes/Probable/No) based on Fleischner Criteria. UIP defined as Honey-combing with basal and subpleural distribution.
Progression: The subset of patients who have had their T4 (5 year post baseline) screening scanned will be independently scored as above and in addition will be compared to their baseline scans and scored for progression: Stable, improved, and progressed.
- Conditions
- Interstitial Lung Disease, IPF
- Being tested
- Retrospective observational study
- Keywords
- Interstitial Lung Disease, Interstitial Lung Abnormalities
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective observational studyOther
No intervention to occur
| Study group | Role | What they receive |
|---|---|---|
| CT Lung Cancer Screening Patients | All CT Lung Cancer Screening patients at LHMC from January 1st, 2012 to September 30th, 2014 with an in-network PCP that had baseline CT scans will be scored. A subset of these patients with T4 screening scans will be scored for progression. Receives: Other: Retrospective observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ILA at baseline
Both presence and absence of ILA, as well as phenotypes, will be described for the entire cohort.
Measured: 6 months
Association between baseline ILA (presence/absence) and time to mortality, time to first hospitalization, and time to development of cancer in the full cohort
Kaplan-Meier plots will be generated to visualize the associations between ILA variables and cancer, hospital admission and mortality. The log-rank test will be used to evaluate for a significant association. Cox regression proportional hazards models will be used to test for this association in both univariate and multivariable models. The multivariable model will be adjusted for age, sex, smoking status and pack years exposure.
Measured: 6 months
Progression of ILA
Progression of ILA, defined as worsening of existing ILA or incidence of ILA over 5 years, will be described for the subset of patients with T4 imaging at 5 years. Univariate and multivariable analyses using logistic regression will be performed to test for associations between qualitative ILA characteristics (presence and absence, as well as individual phenotypes in separate models) and progression (yes/no). Stable and improved will be considered no progression, while incident ILA and worsening of existing ILA will be considered progression. Models will be checked for influential points. Multivariable models will be adjusted for sex, age, currently smoking, and pack years exposure.
Measured: 6 months
Secondary outcomes (2)
Association between phenotypes of ILA and outcomes
Using Kaplan-Meier plots and Cox regression analysis to examine association between phenotypes of ILA with time to first hospitalization, cancer, and mortality. The proportional hazards assumption will be checked for all Cox regression models.
Measured: 6 months
Association between ILA and time to cause-specific mortality, hospitalization.
Investigators will investigate the association between ILA (presence/absence) and time to cause-specific mortality (pulmonary, cardiac, cancer, other), as well as cause-specific hospitalization based on primary diagnosis (COPD, PNA, and CHF). The proportional hazards assumption will be checked for all Cox regression models.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start30 Jan 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Lee Gazourian, Lahey Clinic
- Investigators
- Lee Gazourian, MD, Principal investigator, Lahey Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503044
- Sponsor's protocol ID
- 1628689
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.
PubMed 24378917National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
PubMed 21714641Washko GR, Hunninghake GM, Fernandez IE, Nishino M, Okajima Y, Yamashiro T, Ross JC, Estepar RS, Lynch DA, Brehm JM, Andriole KP, Diaz AA, Khorasani R, D'Aco K, Sciurba FC, Silverman EK, Hatabu H, Rosas IO; COPDGene Investigators. Lung volumes and emphysema in smokers with interstitial lung abnormalities. N Engl J Med. 2011 Mar 10;364(10):897-906. doi: 10.1056/NEJMoa1007285.
PubMed 21388308Putman RK, Hatabu H, Araki T, Gudmundsson G, Gao W, Nishino M, Okajima Y, Dupuis J, Latourelle JC, Cho MH, El-Chemaly S, Coxson HO, Celli BR, Fernandez IE, Zazueta OE, Ross JC, Harmouche R, Estepar RS, Diaz AA, Sigurdsson S, Gudmundsson EF, Eiriksdottir G, Aspelund T, Budoff MJ, Kinney GL, Hokanson JE, Williams MC, Murchison JT, MacNee W, Hoffmann U, O'Donnell CJ, Launer LJ, Harrris TB, Gudnason V, Silverman EK, O'Connor GT, Washko GR, Rosas IO, Hunninghake GM; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators; COPDGene Investigators. Association Between Interstitial Lung Abnormalities and All-Cause Mortality. JAMA. 2016 Feb 16;315(7):672-81. doi: 10.1001/jama.2016.0518.
PubMed 26881370Hunninghake GM, Hatabu H, Okajima Y, Gao W, Dupuis J, Latourelle JC, Nishino M, Araki T, Zazueta OE, Kurugol S, Ross JC, San Jose Estepar R, Murphy E, Steele MP, Loyd JE, Schwarz MI, Fingerlin TE, Rosas IO, Washko GR, O'Connor GT, Schwartz DA. MUC5B promoter polymorphism and interstitial lung abnormalities. N Engl J Med. 2013 Jun 6;368(23):2192-200. doi: 10.1056/NEJMoa1216076. Epub 2013 May 21.
PubMed 23692170Doyle TJ, Hunninghake GM, Rosas IO. Subclinical interstitial lung disease: why you should care. Am J Respir Crit Care Med. 2012 Jun 1;185(11):1147-53. doi: 10.1164/rccm.201108-1420PP. Epub 2012 Feb 23.
PubMed 22366047Doyle TJ, Washko GR, Fernandez IE, Nishino M, Okajima Y, Yamashiro T, Divo MJ, Celli BR, Sciurba FC, Silverman EK, Hatabu H, Rosas IO, Hunninghake GM; COPDGene Investigators. Interstitial lung abnormalities and reduced exercise capacity. Am J Respir Crit Care Med. 2012 Apr 1;185(7):756-62. doi: 10.1164/rccm.201109-1618OC. Epub 2012 Jan 20.
PubMed 22268134Horeweg N, van Rosmalen J, Heuvelmans MA, van der Aalst CM, Vliegenthart R, Scholten ET, ten Haaf K, Nackaerts K, Lammers JW, Weenink C, Groen HJ, van Ooijen P, de Jong PA, de Bock GH, Mali W, de Koning HJ, Oudkerk M. Lung cancer probability in patients with CT-detected pulmonary nodules: a prespecified analysis of data from the NELSON trial of low-dose CT screening. Lancet Oncol. 2014 Nov;15(12):1332-41. doi: 10.1016/S1470-2045(14)70389-4. Epub 2014 Oct 1.
PubMed 25282285Horeweg N, van der Aalst CM, Thunnissen E, Nackaerts K, Weenink C, Groen HJ, Lammers JW, Aerts JG, Scholten ET, van Rosmalen J, Mali W, Oudkerk M, de Koning HJ. Characteristics of lung cancers detected by computer tomography screening in the randomized NELSON trial. Am J Respir Crit Care Med. 2013 Apr 15;187(8):848-54. doi: 10.1164/rccm.201209-1651OC.
PubMed 23348977Pastorino U, Silva M, Sestini S, Sabia F, Boeri M, Cantarutti A, Sverzellati N, Sozzi G, Corrao G, Marchiano A. Prolonged lung cancer screening reduced 10-year mortality in the MILD trial: new confirmation of lung cancer screening efficacy. Ann Oncol. 2019 Jul 1;30(7):1162-1169. doi: 10.1093/annonc/mdz117.
PubMed 30937431Miller ER, Putman RK, Vivero M, Hung Y, Araki T, Nishino M, Washko GR, Rosas IO, Hatabu H, Sholl LM, Hunninghake GM. Histopathology of Interstitial Lung Abnormalities in the Context of Lung Nodule Resections. Am J Respir Crit Care Med. 2018 Apr 1;197(7):955-958. doi: 10.1164/rccm.201708-1679LE. No abstract available.
PubMed 28934558Ash SY, Harmouche R, Ross JC, Diaz AA, Hunninghake GM, Putman RK, Onieva J, Martinez FJ, Choi AM, Lynch DA, Hatabu H, Rosas IO, Estepar RSJ, Washko GR. The Objective Identification and Quantification of Interstitial Lung Abnormalities in Smokers. Acad Radiol. 2017 Aug;24(8):941-946. doi: 10.1016/j.acra.2016.08.023. Epub 2016 Dec 15.
PubMed 27989445Ash SY, Harmouche R, Putman RK, Ross JC, Diaz AA, Hunninghake GM, Onieva Onieva J, Martinez FJ, Choi AM, Lynch DA, Hatabu H, Rosas IO, San Jose Estepar R, Washko GR; COPDGene Investigators. Clinical and Genetic Associations of Objectively Identified Interstitial Changes in Smokers. Chest. 2017 Oct;152(4):780-791. doi: 10.1016/j.chest.2017.04.185. Epub 2017 May 12.
PubMed 28506611Araki T, Putman RK, Hatabu H, Gao W, Dupuis J, Latourelle JC, Nishino M, Zazueta OE, Kurugol S, Ross JC, San Jose Estepar R, Schwartz DA, Rosas IO, Washko GR, O'Connor GT, Hunninghake GM. Development and Progression of Interstitial Lung Abnormalities in the Framingham Heart Study. Am J Respir Crit Care Med. 2016 Dec 15;194(12):1514-1522. doi: 10.1164/rccm.201512-2523OC.
PubMed 27314401Putman RK, Gudmundsson G, Axelsson GT, Hida T, Honda O, Araki T, Yanagawa M, Nishino M, Miller ER, Eiriksdottir G, Gudmundsson EF, Tomiyama N, Honda H, Rosas IO, Washko GR, Cho MH, Schwartz DA, Gudnason V, Hatabu H, Hunninghake GM. Imaging Patterns Are Associated with Interstitial Lung Abnormality Progression and Mortality. Am J Respir Crit Care Med. 2019 Jul 15;200(2):175-183. doi: 10.1164/rccm.201809-1652OC.
PubMed 30673508
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Lung Abnormalities--Qualitative Imaging Cohort Study in CT Lung Cancer Screening Population
- ClinicalTrials.gov ID
- NCT04503044
- Acronym / sponsor ID
- 1628689
- Conditions
- Interstitial Lung Disease, IPF
- Keywords
- Interstitial Lung Disease, Interstitial Lung Abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,703 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interstitial Lung Abnormalities (ILA) have been previously defined as nondependent changes affecting more than 5% of any lung zone on computed tomography (CT) scans of the lung. Several studies suggest that the prevalence of ILA in participants in non-pulmonary research studies ranges anywhere from 7-9%. Work over the last decade has shown that, despite previous characterization as an asymptomatic research finding, ILA has significant clinical and biological consequences. These include reduced exercise capacity, functional limitations, decreased lung volumes, increased mortality, and in some cases histopathology similar to Idiopathic Pulmonary Fibrosis (IPF). ILA have been detected in lung cancer screening cohorts, where the prevalence of ILA is estimated to be between (10%-20%) to those noted in other research cohorts. Given that a significant proportion of those will have progression, CT lung cancer screening (CTLS) cohorts represent an ideal catchment population for future research and clinical trials. Lahey Hospital and Medical Center was one of the earliest clinical centers to develop a CTLS program in the country. Investigators propose to qualitatively characterize ILA in a large clinical CTLS population.
Detailed description
Investigators propose a retrospective, single-center study with following aims:
- Characterize the prevalence and incidence of ILA at baseline and 5 year follow-up, respectively, and associated imaging phenotypes in CTLS cohort.
- Baseline qualitative ILA features associated with clinical outcomes: Lung Cancer, Hospitalization, and Mortality.
- Baseline qualitative ILA features associated with progressive ILA and fibrotic lung disease.
- Clinical opportunity: to determine the % of CTLS patients with ILA who are at risk for progressive and development of fibrotic lung disease and who would benefit from specialized care referral and potential enrollment in clinical trials utilizing proven antifibrotic therapies
Patient Selection:
All clinical CT Lung Cancer Screening (CTLS) patients at Lahey Hospital and Medical Center (LHMC), Burlington, MA from January 1st, 2012 through September 30th, 2014 who had an in network primary care physician (n=1703). Patients with T4 screening scans will be scored for progression (n=653). To qualify for our study, patients had to satisfy the National Comprehensive Cancer Network (NCCN) Guidelines® Lung Cancer Screening Version 1.2012 high-risk criteria for lung cancer. Based on the NCCN Guidelines®, individuals eligible for lung cancer screening can be classified into NCCN group 1 and 2 as previously described. Patients in both groups were asymptomatic and had a physician order for CTLS, were free of lung cancer for ≥ 5 years, and had no known metastatic disease.
Clinical Variables:
Clinical variables were collected prospectively as part of the CTLS program and stored in a centralized data repository. Additional clinical variables not already available in this data repository will be collected retrospectively by manual review of the electronic medical record or pulled directly from the EMR and stored utilizing a custom-designed database (FileMaker ProVersion 11; Filemaker Inc, Santa Clara, California). Data was obtained through September 30th, 2019, patient demographics, past medical history, PFTs, immunization records, whether the patient was managed by a pulmonologist, and for hospital admissions with principal admission diagnoses. Hospital admissions will be collected using Lahey administrative coding data. Principal admission diagnoses of COPD, PNA, and CHF will be characterized based on diagnosis codes per 2018 Center for Medicare and Medicaid Services (CMS) condition-specific measures.
CT Imaging:
Clinically acquired, CTLS examinations which were performed on ≥64-row multidetector CT scanners (LightSpeed VCT and Discovery VCT [GE Medical Systems, Milwaukee, Wisconsin]; Somatom Definition [Siemens AG, Erlangen, Germany]; iCT [Philips Medical Systems, Andover, Massachusetts]) at 100 kV and 30 to 100 mA, depending on the scanner and the availability of iterative reconstruction software. Axial images were obtained at 1.25- to 1.5-mm thickness with 50% overlap and reconstructed with both soft tissue and lung kernels.
Qualitative ILA Scoring:
CT images will be scored utilizing Philips Intellispace PACS version 4.4 with clinical grade monitors. Scoring will be performed independently by two thoracic radiologists as described previously. Scores that are discordant between the two radiologists will be scored by a third by a pulmonologist with expertise in ILD.
ILA: The presence of ILA features will be scores as (Yes/No/Indeterminate). Indeterminate will be defined as features identified unilaterally/focal involvement.
ILA features that will be scored include: A) non dependent ground glass, B) reticular abnormalities, C) traction bronchiectasis and D) honeycombing.
- Non Dependent ground glass: (Yes/No/Indeterminate) defined as hazy increased attenuation of the lung with preservation of bronchial and vascular margins.
- Reticular abnormalities: (Yes/No/Indeterminate) defined as a collection of innumerable small linear opacities that, by summation, produce an appearance resembling a net.
- Traction Bronchiectasis: (Yes/No/Indeterminate) defined Traction bronchiectasis and traction bronchiolectasis respectively represents irregular bronchial and bronchiolar dilatation caused by surrounding retractile pulmonary fibrosis.
- Honeycombing: (Yes/No/Indeterminate) defined on CT as clustered cystic air spaces, typically of comparable diameters on the ordered of 3-10 mm but occasionally as large as 2.5 cm.
Pattern: The overall pattern/Type of ILA findings will also be scored as the following: Subpleural, centrilobular, mixed or consistent with ILD (see UIP below).
Subpleural: Defined as less than 1 cm from the pleural surface.
Centrilobular: Defined as region of the bronchiolovascular core of the secondary pulmonary lobule.
Location: Overall location ILA will then be scored as Upper lobe, lower lobe or diffuse.
Extent: Overall extent of disease will be scored as Mild, Moderate and Marked.
Usual Interstitial Pneumonia: Finally, the subset of scans that have evidence of fibrotic disease defined as traction bronchiectasis/honeycombing will then be classified as consistent with usual interstitial pneumonia (UIP) (Yes/Probable/No) based on Fleischner Criteria. UIP defined as Honey-combing with basal and subpleural distribution.
Progression: The subset of patients who have had their T4 (5 year post baseline) screening scanned will be independently scored as above and in addition will be compared to their baseline scans and scored for progression: Stable, improved, and progressed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT Lung Cancer Screening Patients | – | Other: Retrospective observational studyAll CT Lung Cancer Screening patients at LHMC from January 1st, 2012 to September 30th, 2014 with an in-network PCP that had baseline CT scans will be scored. A subset of these patients with T4 screening scans will be scored for progression. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All clinical CTLS patients at Lahey Hospital and Medical Center (LHMC), Burlington, MA from January 1st, 2012 through September 30th, 2014 who had an in network primary care physician (n=1703). Patients with T4 screening scans will be scored for progression (n=653). To qualify for our study, patients had to satisfy the National Comprehensive Cancer Network (NCCN) Guidelines® Lung Cancer Screening Version 1.2012 high-risk criteria for lung cancer. Based on the NCCN Guidelines®, individuals eligible for lung cancer screening can be classified into NCCN group 1 and 2 as previously described.21 Patients in both groups were asymptomatic and had a physician order for CTLS, were free of lung cancer for ≥ 5 years, and had no known metastatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective observational studyNo intervention to occur | Other | CT Lung Cancer Screening Patients |
Primary outcome
Prevalence of ILA at baseline
Time frame: 6 months
Both presence and absence of ILA, as well as phenotypes, will be described for the entire cohort.
Association between baseline ILA (presence/absence) and time to mortality, time to first hospitalization, and time to development of cancer in the full cohort
Time frame: 6 months
Kaplan-Meier plots will be generated to visualize the associations between ILA variables and cancer, hospital admission and mortality. The log-rank test will be used to evaluate for a significant association. Cox regression proportional hazards models will be used to test for this association in both univariate and multivariable models. The multivariable model will be adjusted for age, sex, smoking status and pack years exposure.
Progression of ILA
Time frame: 6 months
Progression of ILA, defined as worsening of existing ILA or incidence of ILA over 5 years, will be described for the subset of patients with T4 imaging at 5 years. Univariate and multivariable analyses using logistic regression will be performed to test for associations between qualitative ILA characteristics (presence and absence, as well as individual phenotypes in separate models) and progression (yes/no). Stable and improved will be considered no progression, while incident ILA and worsening of existing ILA will be considered progression. Models will be checked for influential points. Multivariable models will be adjusted for sex, age, currently smoking, and pack years exposure.
2 secondary outcomes
Association between phenotypes of ILA and outcomes
Time frame: 6 months
Association between ILA and time to cause-specific mortality, hospitalization.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 24378917Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.
- Background: PubMed 21714641National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
- Background: PubMed 21388308Washko GR, Hunninghake GM, Fernandez IE, Nishino M, Okajima Y, Yamashiro T, Ross JC, Estepar RS, Lynch DA, Brehm JM, Andriole KP, Diaz AA, Khorasani R, D'Aco K, Sciurba FC, Silverman EK, Hatabu H, Rosas IO; COPDGene Investigators. Lung volumes and emphysema in smokers with interstitial lung abnormalities. N Engl J Med. 2011 Mar 10;364(10):897-906. doi: 10.1056/NEJMoa1007285.
- Background: PubMed 26881370Putman RK, Hatabu H, Araki T, Gudmundsson G, Gao W, Nishino M, Okajima Y, Dupuis J, Latourelle JC, Cho MH, El-Chemaly S, Coxson HO, Celli BR, Fernandez IE, Zazueta OE, Ross JC, Harmouche R, Estepar RS, Diaz AA, Sigurdsson S, Gudmundsson EF, Eiriksdottir G, Aspelund T, Budoff MJ, Kinney GL, Hokanson JE, Williams MC, Murchison JT, MacNee W, Hoffmann U, O'Donnell CJ, Launer LJ, Harrris TB, Gudnason V, Silverman EK, O'Connor GT, Washko GR, Rosas IO, Hunninghake GM; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators; COPDGene Investigators. Association Between Interstitial Lung Abnormalities and All-Cause Mortality. JAMA. 2016 Feb 16;315(7):672-81. doi: 10.1001/jama.2016.0518.
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- Background: PubMed 25282285Horeweg N, van Rosmalen J, Heuvelmans MA, van der Aalst CM, Vliegenthart R, Scholten ET, ten Haaf K, Nackaerts K, Lammers JW, Weenink C, Groen HJ, van Ooijen P, de Jong PA, de Bock GH, Mali W, de Koning HJ, Oudkerk M. Lung cancer probability in patients with CT-detected pulmonary nodules: a prespecified analysis of data from the NELSON trial of low-dose CT screening. Lancet Oncol. 2014 Nov;15(12):1332-41. doi: 10.1016/S1470-2045(14)70389-4. Epub 2014 Oct 1.
- Background: PubMed 23348977Horeweg N, van der Aalst CM, Thunnissen E, Nackaerts K, Weenink C, Groen HJ, Lammers JW, Aerts JG, Scholten ET, van Rosmalen J, Mali W, Oudkerk M, de Koning HJ. Characteristics of lung cancers detected by computer tomography screening in the randomized NELSON trial. Am J Respir Crit Care Med. 2013 Apr 15;187(8):848-54. doi: 10.1164/rccm.201209-1651OC.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Gazourian, MD principal investigator
Lahey Hospital & Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and IPF, run by Lahey Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ILA at baseline (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04503044, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.