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The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy

Primary Objective

The Lung PCA BU goals include enrollment of informative retrospective and prospective patients from which informative biospecimens can be collected and processed for advanced analyses of PMLs. Central to this process will be the development of techniques to optimize data production from limited tissues. The generation of a deep and interactive database will be critical to help direct the studies undertaken by the project. Visual maps will serve as the key information hubs and the development of these maps along with the functionality for them to be linked with extensive clinical databases and well annotated metadata will be a major endpoint for the project.

Study category: Respiratory

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Description

This protocol pertains specifically to the prospective lung squamous cell carcinoma pre-malignant lesion (PML) cohort that will form a primary study group for the Lung Pre-Cancer Atlas. Via pre-screening, veteran and non-veteran subjects at high risk for the development of lung squamous cell carcinoma (SCC) will be identified and enrolled to undergo serial bronchoscopies at 12 month intervals over a 2-3 year period. A variety of specimen types will be collected to support analyses of the genomic and microenvironmental features of these PMLs.

Details
Age

Adult

Eligibility

Pre-Screening Inclusion Criteria Patients that have consented to the pre-screening with any of the clinical histories described below, will be asked to provide a screening sputum sample and undergo a bronchoscopy. The bronchoscopy is contingent on the identification of moderate or worse bronchial epithelial atypia by sputum cytology. Those patients with moderate or worse atypia on sputum cytology will be offered bronchoscopic examination and tissue sampling. If findings from the bronchoscopy meet Main Study Group inclusion criteria, the patients will be offered a chance to enroll in the main study. The following criteria will be used to identify potential pre-screening enrollees: 5.3.1.1 A current or ex-smoker with a > 20 pack-year history of smoking. 5.3.1.2 History of non-small cell lung cancer (stage I, II, or IIIA) with > 10 pack-year history of smoking and no evidence of active disease at least 1 year after definitive treatment. 5.3.1.3 History of head and neck cancer (stage I, II, III, or IVA) with > 10 pack-year history of smoking and no evidence of active disease at least 1 year after definitive treatment.

Detailed Eligibility: Main Study Group Inclusion Criteria Enrollment in the main study group can occur via two routes (see flow chart, figure 6, right side). If inclusion criteria described below are already present from results of a prior bronchoscopy the patient may be enrolled directly. The second route will involve evaluation of results obtained in the pre-screening arm (figure 6, left side). When a prescreening bronchoscopy shows biopsy histologic findings that meet the pre-requisites shown below, the patient will be offered enrollment in the Main Study Group where they will be offered three more bronchoscopic examinations including the baseline bronchoscopy and those performed at one and two years after the baseline bronchoscopy. Note, the pre-screening bronchoscopy cannot represent the main study group baseline bronchoscopy as costs associated with specialized specimen collection in the main study group (single cell processing, etc.) cannot be covered in the pre-screening bronchoscopy. The qualifying additional pre-requisites for enrollment in the Main Study Group are: 1. Participants must be able and willing to undergo a total of at least three bronchoscopies. 2. Prior results from bronchoscopic analyses (via previous results or from pre-screening cohort bronchoscopies) must meet either of the following criteria to qualify patients as potential Main Study Group enrollees: 5.3.2.1 Pre-existing bronchoscopic documentation of persistence of or progression to high grade dysplasia at two or more airway sites. 5.3.2.2 Endobronchial dysplasia (squamous metaplasia/mild dysplasia, score > 3) at > 3 airway sites. 5.3.2.3 High grade bronchial dysplasia (moderate dysplasia or worse, score > 5) involving at least one airway site.

Phase

Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.

Type of Study

Screening

Scope

Local

Locations

Rocky Mountain Regional VA Medical Center
University of Colorado Hospital

Principal Investigator
Robert Keith

Robert Keith

Study ID

Protocol Number: 19-0400

ClinicalTrials.gov: NCT03881098

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