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

NCT03881098 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-01-29

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Bronchoscopies

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.

PROCEDURE

Sputum 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.

PROCEDURE

Venipuncture

Thirty milliliters of blood will be withdrawn from each subject, and the blood will be sent to the biorepository for analysis and storage.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Robert Keith, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-06
Primary Completion
2027-12-31
Completion
2028-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03881098 on ClinicalTrials.gov