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Atlas of Pulmonary Premalignancy

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ClinicalTrials.gov Identifier: NCT03881098
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE March 7, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date July 23, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • 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 cytologic specimens for the purposes of reducing lung cancer mortalities.
  • 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 cytologic 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03881098 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atlas of Pulmonary Premalignancy
Official Title  ICMJE The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy
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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Squamous Cell Carcinoma Pre-Malignant Lesions
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.
Interventions:
  • Procedure: Bronchoscopies
  • Procedure: Sputum Sample
  • Procedure: Venipuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2019)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

Prerequisites for Inclusion in Either Study Group:

  1. Provision of signed and dated informed consent form.
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. 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:

  1. A current or ex-smoker with a > 20 pack-year history of smoking.
  2. 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.
  3. 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:

  1. Participants must be able and willing to undergo a total of at least three bronchoscopies.
  2. 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)

Exclusion Criteria

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

  1. Clinically apparent bleeding diathesis.
  2. 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.
  3. Hypoxemia (less than 90% saturation with supplemental oxygen) prior to bronchoscopy.
  4. 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.
  5. Acute bronchitis or pneumonia within 8 weeks, except if these are considered clinically to be possibly a result of lung cancer.
  6. Inability to give informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary K Jackson 303-724-1650 mary.k.jackson@ucdenver.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03881098
Other Study ID Numbers  ICMJE 19-0400.cc
P30CA046934 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators  ICMJE
Principal Investigator: Robert Keith, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP