Overview

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.

Eligibility

Inclusion Criteria

Prerequisites for Inclusion in Either Study Group:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged > 18 years.

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:
          1. A current or ex-smoker with a > 20 pack-year history of smoking.
          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.
          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.
        Main Study Group Inclusion Criteria:
        Enrollment in the main study group can occur via two routes. 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. 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:
               -  Pre-existing bronchoscopic documentation of persistence of or progression to high
                  grade dysplasia at two or more airway sites.
               -  Endobronchial dysplasia (squamous metaplasia/mild dysplasia, score > 3) at > 3
                  airway sites.
               -  High grade bronchial dysplasia (moderate dysplasia or worse, score > 5)
        Exclusion Criteria
        Patients will not eligible if any one of the following conditions are present:
          1. Clinically apparent bleeding diathesis.
          2. Cardiac dysrhythmia that is potentially life threatening, such as ventricular
             tachycardia, multifocal premature ventricular contractions or supraventricular
             tachycardias with a rapid ventricular response. Well-controlled atrial fibrillation or
             rare (< 2/minute) premature ventricular contractions are not exclusionary.
          3. Hypoxemia (less than 90% saturation with supplemental oxygen) prior to bronchoscopy.
          4. Evidence of clinically active coronary artery disease, including myocardial infarction
             within 6 weeks, anginal chest pain, or poorly controlled congestive heart failure, or
             any other serious medical condition which would preclude a patient from undergoing a
             bronchoscopy.
          5. Acute bronchitis or pneumonia within 8 weeks, except if these are considered
             clinically to be possibly a result of lung cancer.
          6. Inability to give informed consent.