RECRUITING

Bronchoscopy in Determining the Effect of E-Cigarette Smoking on Biomarkers in the Lungs

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Conditions

Cigarette SmokerCurrent Every Day Smoker

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This trial studies biomarkers obtained by bronchoscopy (bronchoalveolar lavage and lung brushings) to determine the effect of smoking e-cigarettes on the lungs. Studying samples of lung cells from participants who smoke e-cigarettes may help doctors learn more about changes that occur in deoxyribonucleic acid and identify biomarkers related to cancer.

Official Title

The Effects of a Standardized Research E-Cigarette on the Human Lung: A Clinical Trial With Bronchoscopic Biomarkers

Quick Facts

Study Start:2018-09-17
Study Completion:2023-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03691350

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 52 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Smokers who smoke \>= 5 filtered cigarettes/day for \>= 1 year
  2. * No unstable or significant medical conditions as determined by medical history to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures
  3. * Able to read adequately to complete the survey and related study documents or give consent
  4. * Subject has provided written informed consent to participate in the study
  1. * Regular consumption of roll your own cigarettes
  2. * Immune system disorders requiring medication
  3. * Prior diagnosis of chronic pulmonary disease (e.g., asthma with regular use of medications, chronic obstructive pulmonary disease \[COPD\], chronic bronchitis, and restrictive lung disease)
  4. * Acute bronchitis or pneumonia within 1 year
  5. * Reported history of diagnosed kidney or liver disease
  6. * Any medical disorder that will increase the risk from bronchoscopy, affect biomarker data, or increase risk of an adverse effect from e-cig use
  7. * General anesthesia within 1 year
  8. * Regular use of inhalant medications in the last 2 months
  9. * Use of antibiotics in prior 30 days
  10. * Use of steroids, including corticosteroids, in prior 30 days
  11. * Allergies to study medications, such as, lidocaine, Versed, fentanyl or Cetacaine
  12. * Allergies to propylene glycol/glycerin or flavors
  13. * History of hypersensitivity to varenicline
  14. * Bronchoscopy or any other lung procedure for any reason within the previous 6 months
  15. * Current or recent (within three months) alcohol or drug abuse problems
  16. * Regularly smoked marijuana within the prior 3 months
  17. * Use of an e-cigarette or other combustible tobacco products in the prior 3 months
  18. * Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product) or intention to quit in next three months
  19. * Adverse reaction to previous e-cig use
  20. * Body mass index (BMI) \> 40 (risk of unstable airway)
  21. * Pregnant or breastfeeding - if the subject is female, a urine pregnancy test at no cost to the subject will be done on the day of bronchoscopy
  22. * Unable to read for comprehension or completion of study documents

Contacts and Locations

Study Contact

Ohio State Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu
Sarah Reisinger, MPH, MCHES
CONTACT
614-366-4542
Sarah.Reisinger@osumc.edu

Principal Investigator

Peter Shields, MD
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

  • Peter Shields, MD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-09-17
Study Completion Date2023-12-31

Study Record Updates

Study Start Date2018-09-17
Study Completion Date2023-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cigarette Smoker
  • Current Every Day Smoker