The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy
University of Colorado, Denver
240 participants
Dec 6, 2019
INTERVENTIONAL
Conditions
Summary
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 Criteria12
- Prerequisites for Inclusion in Either Study Group:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged \> 18 years.
- A current or ex-smoker with a \> 20 pack-year history of smoking.
- 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.
- 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.
- Participants must be able and willing to undergo a total of at least three bronchoscopies.
- 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 Criteria7
- Patients will not eligible if any one of the following conditions are present:
- Clinically apparent bleeding diathesis.
- 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.
- Hypoxemia (less than 90% saturation with supplemental oxygen) prior to bronchoscopy.
- 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.
- Acute bronchitis or pneumonia within 8 weeks, except if these are considered clinically to be possibly a result of lung cancer.
- Inability to give informed consent.
Interventions
Bronchoscopy: Your nose, throat, vocal cords and windpipe are sprayed with Lidocaine (numbing medicine) to help keep you from coughing and to numb your airways. A tube with either a white light or the fluorescent light (bronchoscopy) is put down through your nose or mouth into your throat. Your nose, throat, vocal cords and lungs will be checked for any unusual areas while the tube goes down. You might have medicine sprayed into your mouth. You may be given a shot into your vein or muscle to help you be more comfortable. Endobronchial Biopsy: Very tiny pieces of lung tissue (about the size of the head of a pin) will be taken from the lining of your lungs using forceps and a small brush. These tissues will be taken to a laboratory and tested.
Subjects will be asked to perform the early morning spontaneous cough technique over a six-day period to provide for pre-screening evaluations. If moderate atypia is detected in a pre-screening specimen, additional sputum samples will be collected prior to each subsequent bronchoscopy. If this cannot be performed prior to bronchoscopy with adequate results, the sputum collection may be done after bronchoscopy. The sputum will be collected in containers containing Saccomanno's fixative.
Thirty milliliters of blood will be withdrawn from each subject, and the blood will be sent to the biorepository for analysis and storage.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03881098