RECRUITING

Remote Sputum Collection in Cystic Fibrosis

Conditions

Cystic Fibrosis Infections Pseudomonas aeruginosa

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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

Elexacaftor/Tezacaftor/Ivacaftor or Trikafta improves lung health in people with cystic fibrosis (CF), including decreased cough and mucous production. Diagnosing lung infections has become more challenging due to the decrease in sputum and rise of telehealth services. While the option of collecting sputum samples at home and sending them by mail may be feasible, uncertainty remains about how the collection of samples outside of clinic and delays in testing while in the mail impact infection detection. This study will compare bacterial cultures using sputum samples collected at home versus samples collected in clinic (saline-induced sputum and throat swab). This study seeks to shed light on how valuable home collected samples can be and help us better understand the usefulness of home-collected sputum samples for both clinical and research purposes.

Official Title

Remote Sputum Collection in Adults With Cystic Fibrosis

Quick Facts

Study Start:2025-01-15

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06950892

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 Criteria	Exclusion Criteria
* People with a diagnosis of cystic fibrosis (CF) based on CF Foundation (CFF) guidelines. The CFF guidelines consider a diagnosis of CF based on: (1) two known disease-causing CFTR mutations (based on historical genetic testing in clinical documentation or PortCF, the CFF patient registry), OR (2) sweat chloride 60 mmol/L (based on historical sweat chloride testing in clinical documentation or PortCF) and phenotypic findings consistent with cystic fibrosis in more than one organ system, OR (3) CFF accredited center physician diagnosis, based on clinical manifestations in the absence of two CFTR mutations with full gene mapping (based on historical genetic testing in clinical documentation or PortCF). * Age 18 years old or greater * People with the ability to comply with study visits and study procedures as judged by the investigator.	* Solid organ transplant recipients, given the presence of immunosuppression. * Those who are unable to tolerate sputum induction (hypertonic saline) or the inability to attempt sputum expectoration. * Subjects who do not have access to a FedEx location or pick-up services will be excluded.

Inclusion Criteria

Exclusion Criteria

* People with a diagnosis of cystic fibrosis (CF) based on CF Foundation (CFF) guidelines. The CFF guidelines consider a diagnosis of CF based on: (1) two known disease-causing CFTR mutations (based on historical genetic testing in clinical documentation or PortCF, the CFF patient registry), OR (2) sweat chloride 60 mmol/L (based on historical sweat chloride testing in clinical documentation or PortCF) and phenotypic findings consistent with cystic fibrosis in more than one organ system, OR (3) CFF accredited center physician diagnosis, based on clinical manifestations in the absence of two CFTR mutations with full gene mapping (based on historical genetic testing in clinical documentation or PortCF).
* Age 18 years old or greater
* People with the ability to comply with study visits and study procedures as judged by the investigator.

* Solid organ transplant recipients, given the presence of immunosuppression.
* Those who are unable to tolerate sputum induction (hypertonic saline) or the inability to attempt sputum expectoration.
* Subjects who do not have access to a FedEx location or pick-up services will be excluded.

Contacts and Locations

Study Contact

Krista Ludwig

CONTACT

267-283-6223

Krista.ludwig@pennmedicine.upenn.edu

Principal Investigator

Gina Hong, MD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

National Jewish Health

Denver, Colorado, 80206

United States

Johns Hopkins University

Baltimore, Maryland, 21287

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Gina Hong, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

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 Date2025-01-15

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2025-01-15

Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

Cystic Fibrosis
Pseudomonas aeruginosa

Additional Relevant MeSH Terms

Cystic Fibrosis
Infections