RecruitingNot ApplicableNCT03881098

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

Sponsor

University of Colorado, Denver

Enrollment

240 participants

Start Date

Dec 6, 2019

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is building a detailed biological map of the lungs in people who are at high risk for lung cancer — particularly those with early pre-cancerous changes detected on imaging scans. By collecting tissue, blood, and imaging data, researchers hope to understand what drives lung cancer development and find ways to catch it at the earliest possible stage. **You may be eligible if...** - You are a current or former smoker - You have had suspicious or pre-cancerous changes found in your lungs on imaging (such as ground-glass nodules or other abnormal findings) - Your doctor has already recommended a procedure such as a bronchoscopy to evaluate these lung findings - You are willing to consent to sample collection and storage for research **You may NOT be eligible if...** - You are unable to tolerate the required procedures - You are unwilling to consent to sample collection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBronchoscopies

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.

PROCEDURESputum Sample

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.

PROCEDUREVenipuncture

Thirty milliliters of blood will be withdrawn from each subject, and the blood will be sent to the biorepository for analysis and storage.