Atlas Creation for Pre-Cancerous Lung Lesions

Recruiting at 1 trial location

Overseen By Brandi Kubala

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Bleeding diathesis, Cardiac dysrhythmia, Hypoxemia, Coronary artery disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about pre-cancerous lung conditions by examining changes in the lung tissue of individuals at high risk for lung cancer. The research includes procedures such as bronchoscopies (to examine the airways), collecting sputum samples (mucus from the lungs), and blood draws. It is best suited for current or former smokers with a significant smoking history, particularly those who have previously had certain types of cancer but are now cancer-free. Participants will assist researchers in understanding how pre-cancerous lesions behave and develop over time. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to early detection and prevention strategies for lung cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for participants?

Research has shown that bronchoscopies are generally safe and well-tolerated. They often help detect lung cancer and pre-cancerous spots with minimal risk of serious side effects. Most individuals do not experience severe problems, though some may have a mild cough or sore throat afterward.

Collecting sputum samples, which involves gathering mucus from the lungs, is also safe. This non-invasive method mainly requires coughing up mucus into a container, providing a simple way to check for lung issues without major risks.

Venipuncture, or drawing blood from a vein, is a common procedure. It is usually safe and may cause only minor discomfort or bruising at the needle site. Serious side effects are rare.

Overall, these procedures are standard in medical settings and have a strong safety record. They play an important role in assessing lung health without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to create an atlas for pre-cancerous lung lesions, which could be groundbreaking in managing lung cancer risk. Unlike typical treatments that focus on dealing with existing cancer, this approach targets lesions at a pre-malignant stage, potentially preventing cancer development altogether. By using bronchoscopies, sputum samples, and venipuncture, this method provides a comprehensive view of the lung environment and lesion progression, which could lead to earlier and more precise interventions. This proactive approach is different from current treatments that usually address cancer after it has formed, offering a promising new path for early detection and intervention.

What evidence suggests that bronchoscopies, sputum samples, and venipuncture could be effective for studying pre-cancerous lung lesions?

In this trial, participants will undergo bronchoscopies, which research has shown to be effective in diagnosing early lung cancer and precancerous growths. These procedures help identify abnormal tissue growths that could become cancerous. Studies have demonstrated that bronchoscopy is a crucial tool for early diagnosis and treatment planning for lung cancer. Participants will also provide sputum samples, as collecting sputum (mucus from the lungs) aids in early detection. Research indicates that certain tests can accurately determine if these samples are cancerous. Additionally, taking a blood sample through venipuncture can help identify early-stage lung cancer by detecting cancer cells in the blood. This combination of tests offers a comprehensive approach to identifying and understanding lung issues in this trial. ^{2 3 6 7 8}

Who Is on the Research Team?

Robert Keith, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

I do not have serious heart issues or other conditions that would prevent me from having a bronchoscopy.

Patients will not eligible if any one of the following conditions are present:

I do not have severe heart rhythm problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Screening

Subjects at high risk for lung squamous cell carcinoma are identified

2-4 weeks

Bronchoscopy

Participants undergo serial bronchoscopies at 12-month intervals to collect specimens

2-3 years

Annual visits for bronchoscopy

Follow-up

Participants are monitored for safety and effectiveness after bronchoscopy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bronchoscopies
• Sputum Sample
• Venipuncture

Trial Overview

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.

How Is the Trial Designed?

Group I: Squamous Cell Carcinoma Pre-Malignant Lesions Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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

Industry Sponsor

Trials

515

Recruited

845,000+

Joaquin Duato

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

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

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

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Flexible fiberoptic bronchoscopy (FFB) demonstrated a diagnostic yield of 58% in a study of 720 patients, effectively diagnosing conditions such as tuberculosis (67% of suspected cases) and malignancy (61.2% of suspected cases).

The procedure had a low complication rate of 5%, with pneumothorax occurring in only 0.56% of cases, indicating that FFB is a safe diagnostic tool for respiratory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yield and complications of flexible fiberoptic bronchoscopy in a teaching hospital. Alzeer, AH., Al-Otair, HA., Al-Hajjaj, MS.[2008]

In a study of 616 bronchoscopies at a Swiss university hospital, routine bronchoscopy techniques, including transbronchial needle aspiration and biopsy, achieved a high diagnostic yield of 57%, confirming malignancy in 43% of suspected tumor cases.

The procedure was found to be very safe, with only 1.6% of cases experiencing minor complications, indicating that bronchoscopy is a reliable method for diagnosing respiratory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic yield of flexible bronchoscopy in current clinical practice. Joos, L., Patuto, N., Chhajed, PN., et al.[2022]

In a study of 259 lung transplant recipients undergoing flexible fiberoptic bronchoscopy, complications occurred in only 0.7% of procedures, indicating that bronchoscopy is generally safe for these patients.

The involvement of trainees in bronchoscopies did not significantly increase the rate of complications, suggesting that trainee participation is safe and does not adversely affect patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An analysis of potential risk factors for early complications from fiberoptic bronchoscopy in lung transplant recipients. Smith, L., Singer, JP., Hayes, M., et al.[2012]

Flexible fiberoptic bronchoscopy is a safe procedure with a mortality rate of 0%, and while complications like hypoxemia and pneumothorax can occur, they are generally minor and self-limiting.

The procedure is particularly useful for diagnosing conditions such as lung cancer and tuberculosis, with a significant correlation found between lung cancer diagnoses and a history of smoking, highlighting the importance of patient history in evaluating bronchoscopic findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bronchoscopy, indications, safety and complications. Alamoudi, OS., Attar, SM., Ghabrah, TM., et al.[2008]

Fiberoptic bronchoscopy is an important tool for diagnosing and treating patients with serious lung diseases, highlighting its efficacy in managing pulmonary conditions.

The review emphasizes the importance of proper nursing care before, during, and after the procedure to ensure patient safety and optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bronchoscopy in critically ill patients. When is it appropriate? Khawaja, IT., Ebinger, D., Cinquina, L.[2019]

In a study of 1,100 interventional pulmonology procedures, trainee involvement was linked to longer procedure times (average of 50.81 minutes compared to 32.49 minutes) and increased sedation requirements, indicating a potential impact on efficiency.

The presence of trainees also correlated with a higher complication rate (4.5% with trainees vs. 1.2% without), suggesting that while training is essential, it may pose additional risks to patients during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trainee impact on procedural complications: an analysis of 967 consecutive flexible bronchoscopy procedures in an interventional pulmonology practice. Stather, DR., MacEachern, P., Chee, A., et al.[2022]

Fiberoptic bronchoscopy is an effective method for obtaining bronchial biopsies, transbronchial biopsies, and bronchoalveolar lavage (BAL) in patients with chronic inflammatory diseases like asthma and COPD.

Bronchial biopsies provide detailed anatomical information about the airway structure, allowing for a comprehensive examination of various components of the bronchial wall, which is not possible with other sampling techniques like induced sputum or BAL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biopsy techniques : optimization for collection and preservation. Saetta, M., Turato, G.[2011]

A new needle-type sampling device was developed for use with flexible ultrathin bronchoscopes, allowing for effective diagnosis of hard-to-reach peripheral lung lesions in 10 patients, with successful sampling in all cases.

This novel system provides sufficient specimens for cytology, enhancing the accuracy and minimally invasive nature of diagnosing peripheral pulmonary lesions compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel needle-type sampling device for flexible ultrathin bronchoscopy. Suda, Y., Tanaka, A., Hayashi, K., et al.[2019]

The Transbronchial Access Tool demonstrated a 71% overall diagnostic yield in accessing peripheral pulmonary nodules/masses during navigational bronchoscopy, with a perfect 100% yield when following a standardized protocol in the last 7 patients.

The procedure was found to be safe, with only one complication (a pneumothorax) reported among 14 patients, and average radiation exposure was relatively low at 4.3 mSv.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of the Transbronchial Access Tool for Peripheral Pulmonary Nodule and Mass. Bowling, MR., Brown, C., Anciano, CJ.[2022]

Fiberoptic bronchoscopy is an essential procedure in the intensive care unit, aiding in both airway management and providing diagnostic and treatment options.

Expertise in performing fiberoptic bronchoscopy is crucial, especially for complex cases involving airway issues or significant bleeding, to ensure safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bronchoscopic procedures in the intensive care unit. Silver, MR., Balk, RA.[2008]

Flexible fiberoptic bronchoscopy, developed in the late 1960s, has significantly advanced the diagnosis of tumors and interstitial lung diseases, highlighting its importance in modern medical practice.

The abstract emphasizes the critical role of transbronchial biopsy techniques and the management of biopsy samples, as accurate interpretation of these small tissue fragments is essential for effective diagnosis, while also noting potential complications like pneumothorax and hemorrhage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Histologic examinations during bronchial endoscopy: bronchial and transbronchial biopsy]. Febvre, M., Capron, F.[2006]

In a study of 46 patients undergoing fiberoptic bronchoscopy for pulmonary lesions, definitive diagnoses were successfully established in all cases using various biopsy techniques, including forceps and brush biopsies.

The use of fluoroscopic localization during the procedure significantly improved the diagnostic yield for peripheral lesions, making it comparable to that of more central lesions, highlighting its importance in enhancing diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increases in diagnostic yield of fiberoptic bronchoscopy by fluoroscopy. Cummings, CL., Brooks, IO., Stinson, JM.[2018]

In a study of 114 patients diagnosed with lung cancer, bronchial washings provided the highest diagnostic yield at 75.4%, while forceps biopsy followed closely at 65.8%.

The combination of bronchial washings and forceps biopsy resulted in an impressive diagnostic yield of 95.8%, highlighting the importance of using multiple techniques during fiberoptic bronchoscopy for accurate lung cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fiberoptic bronchoscopy. Comparison of procedures used in the diagnosis of lung cancer. Chaudhary, BA., Yoneda, K., Burki, NK.[2008]

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