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Atlas Creation for Pre-Cancerous Lung Lesions
N/A
Recruiting
Led By Robert Keith, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A current or ex-smoker with a > 20 pack-year history of smoking.
Participants must be able and willing to undergo a total of at least three bronchoscopies.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of study to post baseline bronchoscopy, up to two years
Awards & highlights
Study Summary
This trial will follow patients with pre-cancerous lung lesions to create a better understanding of how these lesions develop into cancer.
Who is the study for?
This trial is for adults over 18 who've had non-small cell lung cancer (stages I-III) or head and neck cancer, are heavy smokers/ex-smokers with a history of at least 10 pack-years, have no active disease for a year post-treatment, and can undergo multiple bronchoscopies. They must consent to the study's procedures and be available throughout.Check my eligibility
What is being tested?
The study involves collecting sputum samples and performing venipuncture and bronchoscopies on participants to create an atlas of pre-malignant lesions in lung squamous cell carcinoma. It aims to understand the progression from normal cells to pre-cancerous states.See study design
What are the potential side effects?
While this trial does not involve drug interventions that typically have side effects, procedures like bronchoscopy may cause discomfort, coughing, throat irritation, bleeding or infection risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have smoked more than 20 packs of cigarettes a year.
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I am willing and able to undergo at least three bronchoscopies.
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My lung condition has worsened or remained severe at multiple sites, confirmed by a bronchoscopy.
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My lung condition is considered high grade.
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I have abnormal cell growth in more than 3 areas of my airways.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of study to post baseline bronchoscopy, up to two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of study to post baseline bronchoscopy, up to two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine Genomic Features of Pre-Malignant Lesions (PML) via Bronchoscopic Biopsy
Determine Microenvironmental Features of Lung Pre-Malignant Lesions (PML) via Bronchoscopic Biopsy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Squamous Cell Carcinoma Pre-Malignant LesionsExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sputum Sample
2015
N/A
~50
Venipuncture
2021
N/A
~340
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,893 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,286 Total Patients Enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry Sponsor
514 Previous Clinical Trials
844,419 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious heart issues or other conditions that would prevent me from having a bronchoscopy.I have smoked more than 20 packs of cigarettes a year.I had early-stage head and neck cancer, smoked heavily, and have been cancer-free for over a year.I am willing and able to undergo at least three bronchoscopies.I had early-stage lung cancer, smoked for over 10 years, and have been cancer-free for at least a year.I do not have severe heart rhythm problems.My lung condition has worsened or remained severe at multiple sites, confirmed by a bronchoscopy.I agree to provide a sputum sample and may undergo a bronchoscopy based on the test results.I haven't had bronchitis or pneumonia in the last 8 weeks, unless it's possibly due to my lung cancer.My previous lung tests qualify me for the main study group.My lung condition is considered high grade.I can join the study if my previous tests or a new test meet the study's needs.I have a bleeding disorder that is noticeable.I am over 18 years old.I have abnormal cell growth in more than 3 areas of my airways.I am unable to understand and give consent for treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Squamous Cell Carcinoma Pre-Malignant Lesions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been enrolled in this investigation?
"Yes, the research findings on clinicaltrials.gov confirms that this trial is actively recruiting participants. It was initially posted on December 6th 2019 and most recently modified on October 18th 2021. The study seeks to enrol 240 people from 2 different sites."
Answered by AI
Are there any positions still available for potential participants in this trial?
"Affirmative. Clinicaltrials.gov confirms that this medical experiment, which was first publicized on December 6th 2019, is actively searching for participants. About 240 individuals need to be recruited from two different healthcare centres."
Answered by AI
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