RECRUITING

Personalized Theratyping Trial

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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

The purpose of this study is to explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs.

Official Title

Personalized Theratyping Trial

Quick Facts

Study Start:2019-08-01

Study Completion:2026-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03587961

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:6 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosis of CF * Age ≥6 y.o. * CFTR mutation that may respond to approved correctors/potentiators in the opinion of the study investigators * Informed Consent/Assent * Stable CF pulmonary regimen	* Exacerbation requiring antibiotic or steroids for \>28 days before trial entry * Ongoing participation in a CFTR modulator study * Active smoking in the past 6 months * History of solid organ transplant * Any condition which precludes the use of CFTR modulators: e.g. advanced cirrhosis, End-stage Renal Disease (ESRD) * Any condition that precludes the patient from participation in the opinion of the investigator * Any meds that have significant drug-drug interactions or any other off label use of CFTR modulators

Inclusion Criteria

Exclusion Criteria

* Diagnosis of CF
* Age ≥6 y.o.
* CFTR mutation that may respond to approved correctors/potentiators in the opinion of the study investigators
* Informed Consent/Assent
* Stable CF pulmonary regimen

* Exacerbation requiring antibiotic or steroids for \>28 days before trial entry
* Ongoing participation in a CFTR modulator study
* Active smoking in the past 6 months
* History of solid organ transplant
* Any condition which precludes the use of CFTR modulators: e.g. advanced cirrhosis, End-stage Renal Disease (ESRD)
* Any condition that precludes the patient from participation in the opinion of the investigator
* Any meds that have significant drug-drug interactions or any other off label use of CFTR modulators

Contacts and Locations

Study Contact

Heather Hathorne, PhD

CONTACT

205-638-9568

hhathorne@peds.uab.edu

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

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 Date2019-08-01

Study Completion Date2026-09-01

Study Record Updates

Study Start Date2019-08-01

Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

Cystic Fibrosis