RECRUITING

Improving P. Aeruginosa Detection With Breath-based Diagnostics (IMPACT-Breath)

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

The study is a breath biomarker validation study. It is anticipated that 300 patients with cystic fibrosis (CF) from 5 clinical sites in the USA will be enrolled. The study is funded by the US NIH and the US Cystic Fibrosis Foundation. Enrollment commenced in May 2019. Sputum, induced sputum, and oropharyngeal swabs will be collected and evaluated at each clinic as part of standard clinical practice. Excess sputum will be sent to Children's Colorado Hospital for molecular analysis. No swabs will be sent anywhere (other than the clinic from which they originate). Breath samples will be taken from all study participants.

Official Title

Improving P. Aeruginosa Detection With Breath-based Diagnostics (IMPACT-Breath)

Quick Facts

Study Start:2019-05-03
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04735952

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:3 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aim 1, Cross-Sectional
  1. 1. Age \< 8 years
  2. 2. Intermittently infected with Pa
  3. 3. FEV1 \< 30%
  4. 4. History of lung transplant
  5. 5. Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise the safety of the subject or the quality of the data.
  6. 1. Male or female, ages 8-16 years
  7. 2. Diagnosis of CF based on sweat chloride ≥ 60 mmol/L and/or 2 known CF mutations
  8. 3. @ BC Children's Hospital only- Non-expectorators are eligible if having a clinically indicated OP swab.
  9. 4. FEV1 ≥ 30% predicted for spontaneous expectorators or FEV1 ≥ 40% predicted for subjects undergoing sputum induction
  10. 5. P. aeruginosa negative, based on one of the following criteria:
  11. 1. No growth of Pa in previous 12 months and ≥ 4 consecutive Pa-negative cultures
  12. 2. No history of Pa positive airway cultures (sputum, OP, bronchoalveolar lavage)
  13. 6. Willing to participate in and comply with the study procedures and willingness of the subject, parent or legally authorized representative to provide written informed consent.

Contacts and Locations

Study Contact

Jane E Hill, PhD
CONTACT
778 879 5105
jane.hill@ubc.ca
Nina Nouribakikomarolya, PhD
CONTACT
778 325 5038
nina.Nouribakikomarolya@ubc.ca

Principal Investigator

Jane E Hill, PhD
PRINCIPAL_INVESTIGATOR
University of British Columbia

Study Locations (Sites)

Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
National Jewish Health
Denver, Colorado, 80206
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229-3039
United States

Collaborators and Investigators

Sponsor: University of British Columbia

  • Jane E Hill, PhD, PRINCIPAL_INVESTIGATOR, University of British Columbia

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 Date2019-05-03
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2019-05-03
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Breath
  • IMPACT

Additional Relevant MeSH Terms

  • Cystic Fibrosis