Treatment Alternatives in iSGS (NoAAC PR-02 Study)
NoAAC PR-02
Treatment Alternatives in Adult Rare Disease; Assessment of Options in Idiopathic Subglottic Stenosis North American Airway Collaborative PR-02 Study (NoAAC PR-02 Study)
1 other identifier
observational
1,239
4 countries
42
Brief Summary
The study is aimed at answering the questions; (1) How well do the most commonly used treatments in iSGS work? and (2) What quality-of-life trade-offs are associated with each approach? With the results of this trial, the investigators hope to provide information to iSGS patients: (1) Given my personal characteristics, conditions, and preferences, what should I expect will happen to me? and (2) What are my options, and what are the potential benefits and harms of these options?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2015
Longer than P75 for all trials
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2015
CompletedFirst Posted
Study publicly available on registry
June 25, 2015
CompletedStudy Start
First participant enrolled
August 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2020
CompletedOctober 28, 2021
October 1, 2021
5 years
June 22, 2015
October 27, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Treatment Effectiveness: Time to recurrent procedure
3 years
Treatment Effectiveness: Need for tracheostomy
3 years
Secondary Outcomes (8)
QOL
3 years
QOL
3 years
QOL
3 years
QOL
3 years
Patient Reported Outcome
3 years
- +3 more secondary outcomes
Study Arms (1)
iSGS patients
Participants will receive standard of care treatment at the respective center and will be followed longitudinally for symptom changes, need for further treatment, complications, and will have Patient-reported outcomes (PROs) administered at a priori determined intervals.
Interventions
This is accomplished with rigid instruments or inflatable balloons.
This is accomplished with C02 lasers and paired with prolonged medical therapy after surgery.
Resection of the affected tracheal segment with end-to-end anastomosis
Eligibility Criteria
All clinically confirmed iSGS patients at the participating institutions are eligible for enrollment.
You may qualify if:
- Greater than 18 years of age.
- The lesion must involve the subglottis.
You may not qualify if:
- Less than 18 years of age
- Patients without capacity to consent for themselves
- History of significant laryngotracheal traumatic injury.
- History of endotracheal intubation or tracheotomy within 2 years of presentation.
- Major anterior neck surgery.
- History of neck irradiation.
- History of caustic or thermal injuries to the laryngotracheal complex.
- History of a clinically diagnosed vasculitis or collage vascular disease.
- Positive antinuclear cytoplasmic antibody titers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt University Medical Centerlead
- Patient-Centered Outcomes Research Institutecollaborator
- The Cleveland Cliniccollaborator
- University of Utahcollaborator
- Johns Hopkins Universitycollaborator
- Vanderbilt Universitycollaborator
- University of Virginiacollaborator
- Massachusetts Eye and Ear Infirmarycollaborator
- Oregon Health and Science Universitycollaborator
- University of Washingtoncollaborator
- University of California, San Franciscocollaborator
- University of California, Los Angelescollaborator
- University of California, San Diegocollaborator
- University of Colorado, Denvercollaborator
- Baylor College of Medicinecollaborator
- Louisiana State University Health Sciences Center in New Orleanscollaborator
- Charing Cross Hospitalcollaborator
- University of Alabama at Birminghamcollaborator
- University of Wisconsin, Madisoncollaborator
- University of Michigancollaborator
- University of Nebraskacollaborator
- University of Iowacollaborator
- University of Texascollaborator
- Duke Universitycollaborator
- University of North Carolinacollaborator
- Augusta Universitycollaborator
- University of Sydneycollaborator
- North American Airway Collaborativecollaborator
- University of California, Irvinecollaborator
- University of Pittsburghcollaborator
- Loma Linda Universitycollaborator
- Stanford Universitycollaborator
- University of Cincinnaticollaborator
- Emory Universitycollaborator
- Ohio State Universitycollaborator
- University of Southern Californiacollaborator
- Temple Universitycollaborator
- Medical College of Wisconsincollaborator
- Landspitali University Hospitalcollaborator
- Bastian Voice Institutecollaborator
- NYU Langone Healthcollaborator
- Mayo Cliniccollaborator
- University of Miamicollaborator
- University of Rochestercollaborator
Study Sites (42)
The University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Mayo Clinic
Scottsdale, Arizona, 85054, United States
University of California Irvine
Irvine, California, 92606, United States
Loma Linda University Health Care
Loma Linda, California, 92354, United States
University of Southern California
Los Angeles, California, 90033, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
Stanford University
Palo Alto, California, 94304, United States
University of California San Diego
San Diego, California, 92103, United States
University of California San Francisco
San Francisco, California, 94115, United States
University of Colorado
Denver, Colorado, 80045, United States
University of Miami
Miami, Florida, 33136, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Augusta University
Augusta, Georgia, 30912, United States
Bastian Voice Institute
Downers Grove, Illinois, 60515, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Louisiana State University
Baton Rouge, Louisiana, 70809, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
Harvard Medical School -Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
New York University Medical Center
New York, New York, 10016, United States
University of Rochester
Rochester, New York, 14642, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27705, United States
University of Cincinatti
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43212, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22908-0713, United States
University of Washington
Seattle, Washington, 98195, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
University of Sydney
St Leonards, Australia
Landspitali University Hospital
Reykjavik, 101-155, Iceland
Charing Cross Hospital, Imperial College London
London, W6 8RF, United Kingdom
Related Publications (1)
Gelbard A, Shyr Y, Berry L, Hillel AT, Ekbom DC, Edell ES, Kasperbauer JL, Lott DG, Donovan DT, Garrett CG, Sandhu G, Daniero JJ, Netterville JL, Schindler JS, Smith ME, Bryson PC, Lorenz RR, Francis DO. Treatment options in idiopathic subglottic stenosis: protocol for a prospective international multicentre pragmatic trial. BMJ Open. 2018 Apr 10;8(4):e022243. doi: 10.1136/bmjopen-2018-022243.
PMID: 29643170DERIVED
Biospecimen
Biospecimens collected during routine standard of care from each patient (such as tracheal biopsies obtained during surgery, or surgical specimens generated thru open reconstructive surgeries), will be annotated in the EDC with such data including specimen collection, specimen type (e.g., frozen biopsy tissue; FFPE block), and storage location. We may examine excess tissue obtained at standard of care surgical biopsy. Additionally if blood is collected during standard of care (i.e., medically indicated labs, operative or office-based procedures), we will ask participants to provide a one-time, 30 mL blood specimen for research.
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Gelbard, MD
Vanderbilt University Medical Center
- STUDY CHAIR
David O. Francis, MD, MS
Vanderbilt University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Department of Otolaryngology
Study Record Dates
First Submitted
June 22, 2015
First Posted
June 25, 2015
Study Start
August 28, 2015
Primary Completion
September 10, 2020
Study Completion
September 10, 2020
Last Updated
October 28, 2021
Record last verified: 2021-10