Lung CancerNCT03881098
The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy
A study testing Bronchoscopies, Sputum Sample and Venipuncture in people with Lung Cancer, run by University of Colorado, Denver at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Bronchoscopies, Sputum Sample and Venipuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Dec 2019to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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:
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- 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.
- 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:
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rocky Mountain Regional VAMC
Aurora, Colorado, 80045
UCHealth - Metro
Aurora, Colorado, 80045
About this study
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.
Read the detailed description
Via pre-screening, subjects at high risk for the development of lung squamous cell carcinoma (SCC) will be identified and enrolled to undergo serial bronchoscopies at 12 month intervals over a 2-3 year period. A variety of specimen types will be collected to support analyses of the genomic and microenvironmental features of these PMLs.
- Conditions
- Lung Cancer
- Being tested
- Bronchoscopies, Sputum Sample, Venipuncture
- Keywords
- Bronchoscopy, Squamous Cell Carcinoma, Pre-Malignant Lesions, Smoking, Multi-site
- Medical subject headings
- Lung Neoplasms, Carcinoma, Squamous Cell, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopiesProcedure or surgery
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.
Sputum SampleProcedure or surgery
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.
VenipunctureProcedure or surgery
Thirty milliliters of blood will be withdrawn from each subject, and the blood will be sent to the biorepository for analysis and storage.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bronchoscopies; Procedure: Sputum Sample; Procedure: Venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Start of study to post baseline bronchoscopy, up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start6 Dec 2019
- Primary completion31 Dec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Robert Keith, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881098
- Sponsor's protocol ID
- 19-0400.cc
- Status last verified
- Jun 2026
- First submitted
- 7 Mar 2019
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy
- ClinicalTrials.gov ID
- NCT03881098
- Acronym / sponsor ID
- 19-0400.cc
- Conditions
- Lung Cancer
- Keywords
- Bronchoscopy, Squamous Cell Carcinoma, Pre-Malignant Lesions, Smoking, Multi-site
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Via pre-screening, subjects at high risk for the development of lung squamous cell carcinoma (SCC) will be identified and enrolled to undergo serial bronchoscopies at 12 month intervals over a 2-3 year period. A variety of specimen types will be collected to support analyses of the genomic and microenvironmental features of these PMLs.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Squamous Cell Carcinoma Pre-Malignant Lesions | Other | Procedure: Bronchoscopies, Procedure: Sputum Sample, Procedure: VenipunctureThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- 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:
- A current or ex-smoker with a > 20 pack-year history of smoking.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchoscopiesBronchoscopy: 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 or surgery | Squamous Cell Carcinoma Pre-Malignant Lesions |
| Sputum SampleSubjects 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 or surgery | Squamous Cell Carcinoma Pre-Malignant Lesions |
| VenipunctureThirty milliliters of blood will be withdrawn from each subject, and the blood will be sent to the biorepository for analysis and storage. | Procedure or surgery | Squamous Cell Carcinoma Pre-Malignant Lesions |
Primary outcome
Determine Genomic Features of Pre-Malignant Lesions (PML) via Bronchoscopic Biopsy
Time frame: Start of study to post baseline bronchoscopy, up to two years
Prospective data collection of histologic specimens for the purposes of reducing lung cancer mortalities.
Determine Microenvironmental Features of Lung Pre-Malignant Lesions (PML) via Bronchoscopic Biopsy
Time frame: Start of study to post baseline bronchoscopy, up to two years
Prospective data collection of histologic specimens for the purposes of reducing lung cancer mortalities.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Keith, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopies, Sputum Sample and Venipuncture in people with Lung Cancer, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Genomic Features of Pre-Malignant Lesions (PML) via Bronchoscopic Biopsy (time frame: Start of study to post baseline bronchoscopy, up to two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.