Measures of Respiratory Health Registry

NCT05501587 | Recruiting

• 1 other identifier: H18-00812
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

There are many techniques that can allow for the quantification of lung function in children; some are being used clinically and others are under development. Many of these tools are available at BC Children's Hospital. This registry study will act as a central repository for the results of traditional and novel pulmonary function tests done at BC Children's Hospital to allow for future analysis.

Conditions

Respiratory Disease; Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• To validate new lung function testing technologies

  The ultimate objective of this registry is to validate new lung function testing technologies as tools that can be utilized in clinical care.

  10 years

Study Arms (3)

Participants with CF

Participants with other Respiratory Disease

Healthy Participants

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with CF Participants with other Respiratory Disease Healthy Participants

You may qualify if:

• Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria: i. A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT).
• ii. A documented genotype with two disease-causing mutations in the CFTR gene.
• \- In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing

You may not qualify if:

• Physical findings at the screening that would compromise the safety of the participant or the quality of the data (e.g. respiratory distress or work of breathing)
• Requirement of supplementary oxygen to maintain oxygen saturation above 95%
• Participants with other Respiratory Disease
• Physician-diagnosed lung disease
• Informed consent by participant, parent, or legal guardian
• In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing
• Physical findings at screening that would compromise the safety of the participant or the quality of the research data
• Requirement of supplementary oxygen to maintain oxygen saturation above 95%
• Healthy Participants
• Informed consent by participant, parent, or legal guardian
• In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing
• Physical findings at screening that would compromise the safety of the participant or the quality of the research data
• Evidence of lung disease

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Respiration Disorders; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Jonathan Rayment, MDCM, MSc

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo Sandoval, MSc

CONTACT

6048752345; Rodrigo.Sandoval@bcchr.ca

Alam Lakhani

CONTACT

6048752345; alam.lakhani@cw.bc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: October 11, 2018
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Criteria for access to the MRH-Registry Data: The Proposed Study must demonstrate approval by a Qualified REB The objectives of the Proposed Study must align with the scientific objectives of the iMRH-Registry Use of the MRH Registry Data in the Proposed Study must respect the informed consent given by the participants of the iMRH Registry; The Proposed Study must have scientific merit, as assessed by the MRH Registry Data Access Committee The User-Investigator must demonstrate sufficient funding to perform the Proposed Study.

Locations

CA (1)