RECRUITING

Evaluation Of The Lung Microbiome In NTM Bronchiectasis

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

A biomarker cohort study design is proposed to study whether specific airway microbiota alterations are associated with pulmonary Non-tuberculous mycobacteria (NTM) disease. In a cohort of 200 subjects suspected of having pulmonary NTM disease, the investigators will evaluate the airway microbiome using an aliquot of the induced sputum and upper airway samples. Since induced sputum may reflect different regions of the upper/lower airways, the investigators will evaluate the upper and lower airway microbiome in a subgroup (case-control group) of patients using samples obtained through upper airway sampling and bronchoscopy, respectively.

Official Title

Evaluation Of The Lung Microbiome In NTM Bronchiectasis

Quick Facts

Study Start:2014-10-01
Study Completion:2031-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02779478

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of pulmonary symptoms: cough, fatigue, malaise, fever, weight loss, dyspnea, hemoptysis, or chest discomfort
  2. * Imaging abnormalities (within 2 years): defined as nodular or cavitary opacities on chest radiograph, or a computed tomography scan that shows bronchiectasis or bronchial wall thickening with associated multiple small nodules.
  3. * Subjects that meet inclusion criteria and have culture positivity for NTM: at least two separate expectorated induced sputum samples or from one bronchoalveolar lavage (BAL) or lung biopsy
  4. * Subjects that meet inclusion criteria and have less than two separate expectorated induced sputum samples culture negative or culture negative bronchoalveolar lavage (BAL) or lung biopsy.
  5. * Recent (\<1 months prior) oral antibiotic or steroid use. (Continuous treatment with macrolides and inhaled steroids are acceptable \>1 month prior)
  6. * Recent smoking history
  7. * Forced expiratory volume at one second (FEV1) \< 70%of predicted.
  8. * Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
  9. * Diabetes mellitus
  10. * Significant liver or renal disease
  11. * Severe coagulopathy (INR \> 1.4, Partial Thromboplastin Time (PTT) \> 40 seconds and platelet count \< 150x103 cells).
  12. * Pregnancy
  13. * Ethanol (ETOH) use of more than \>6 beers or \>4 mixed drinks daily
  14. * Lack of capacity to provide informed consent.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Lisa Guiterrez
CONTACT
Lira.Gutierrez@nyulangone.org
Rosemary Schluger
CONTACT
Rosemary.Schluger@nyulangone.org

Principal Investigator

Leopoldo Segal, MD
PRINCIPAL_INVESTIGATOR
New York University Medical School

Study Locations (Sites)

New York University School of Medicine
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Leopoldo Segal, MD, PRINCIPAL_INVESTIGATOR, New York University Medical School

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 Date2014-10-01
Study Completion Date2031-07

Study Record Updates

Study Start Date2014-10-01
Study Completion Date2031-07

Terms related to this study

Keywords Provided by Researchers

  • chronic obstructive pulmonary disease (COPD)
  • cavitary
  • nodular bronchiectatic disease
  • NTM

Additional Relevant MeSH Terms

  • Nontuberculous Mycobacteria
  • Bronchiectasis