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

NCT03881098 | Recruiting DMC

• 1 other identifier: 19-0400.cc
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief 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

Lung Cancer

Keywords

Bronchoscopy; Squamous Cell Carcinoma; Pre-Malignant Lesions; Smoking; Multi-site

Outcome Measures

Primary Outcomes (2)

• Determine Genomic Features of Pre-Malignant Lesions (PML) via Bronchoscopic Biopsy

  Prospective data collection of histologic specimens for the purposes of reducing lung cancer mortalities.

  Start of study to post baseline bronchoscopy, up to two years

• Determine Microenvironmental Features of Lung Pre-Malignant Lesions (PML) via Bronchoscopic Biopsy

  Prospective data collection of histologic specimens for the purposes of reducing lung cancer mortalities.

  Start of study to post baseline bronchoscopy, up to two years

Study Arms (1)

Squamous Cell Carcinoma Pre-Malignant Lesions

OTHER

The prospective SCC-PML cohort is envisioned to provide a well-matched group of high-risk subjects that will provide clinically comparable subjects with lesional sites representing progressive and non-progressive disease.

Procedure: Bronchoscopies; Procedure: Sputum Sample; Procedure: Venipuncture

Interventions

Bronchoscopies PROCEDURE

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.

Squamous Cell Carcinoma Pre-Malignant Lesions

Sputum Sample PROCEDURE

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.

Squamous Cell Carcinoma Pre-Malignant Lesions

Venipuncture PROCEDURE

Thirty milliliters of blood will be withdrawn from each subject, and the blood will be sent to the biorepository for analysis and storage.

Squamous Cell Carcinoma Pre-Malignant Lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients will not eligible if any one of the following conditions are present:
• Clinically apparent bleeding diathesis.
• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator

Study Sites (2)

Rocky Mountain Regional VAMC

Aurora, Colorado, 80045, United States

RECRUITING

UCHealth - Metro

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Squamous Cell; Smoking

Interventions

Bronchoscopy; Phlebotomy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Punctures; Therapeutics; Investigative Techniques

Study Officials

• Robert Keith, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandi Kubala

CONTACT

303-724-1657; brandi.kubala@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 19, 2019
• Study Start: December 6, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)