NCT01663948

Brief Summary

The purpose of the international plastic bronchitis registry is to understand the natural course and long term health outcomes of subjects diagnosed with plastic bronchitis due to different types of casts. This provides essential data for identifying best practices and treatments. The secondary aim is to understand the structure of casts and mechanism of their formation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

6.3 years

First QC Date

August 9, 2012

Last Update Submit

March 9, 2020

Conditions

Plastic Bronchitis

Keywords

Plastic bronchitisPB

Outcome Measures

Primary Outcomes (1)

  • natural course and long term health outcomes

    The purpose of the intrnational plastic bronchitis registry is to understand the natural course and long term health outcomes of patients diagnosed with plastic bronchitis. This provides essential data for identifying possible causes of this disease and potential treatments.

    ongoing

Study Arms (1)

Patients with Plastic bronchitis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study is open to patients around the world suffering from Plastic bronchitis

You may qualify if:

  • Diagnosed with Plastic bronchitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Airway Casts

Study Officials

  • Bruce K Rubin, MEngr, MD, MBA, FRCPC

    Children's Hospital of Richmond at VCU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 14, 2012

Study Start

July 1, 2012

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations

US(1)