RECRUITING

Protocol CAUSE-03 / CHEETAH

Conditions

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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

This is a one-year longitudinal, observational study of 250 urban children and adolescents with asthma and 60 without asthma, ages 6-17 years old. Participants with asthma will require daily controller therapy with inhaled corticosteroids ICS (at least Step 2 therapy). Those without asthma cannot have used asthma medications in the year prior to enrollment and cannot demonstrate bronchodilator reversibility at baseline. Phenotypic characteristics will be established at baseline, and the participants will be seen at scheduled visits over 12 months. Each participant will be asked to monitor and self-report cold symptoms and will be asked to complete up to three cold visits

Official Title

Mechanisms Underlying Asthma Symptoms and Exacerbations Examined Across T2 Status in Children (CHEETAH) (CAUSE-03)

Quick Facts

Study Start:2024-04-23

Study Completion:2026-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06136091

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 to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Participant and/or parent guardian must be able to understand and provide informed consent and assent 2. Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Protocol CAUSE-03 Manual of Operations (MOP) 3. Either: 1. Have had a diagnosis of asthma made \> 1 year prior to recruitment; participants who received an asthma diagnosis by a clinician \<= 1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment (asthma group), or 2. No report of ever being diagnosed with asthma (non-asthma group) 4. Either: 1. Require at least Step 2 therapy at the Screening/Enrollment Visit (asthma group), or 2. Have not used any asthma medications in the prior year (non-asthma group) 5. Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to enrollment 6. Have documentation of current medical insurance with prescription coverage at the Screening/Enrollment Visit 7. Participant and/or parent guardian has a smartphone compatible with the study electronic Patient Reported Outcomes (ePRO) system, Medidata Patient Cloud, and is willing to download one application for study use	1. Parent or guardian is not able or willing to give written informed consent or comply with study protocol 2. Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study 3. Are currently receiving immunotherapy 4. Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to enrollment 5. Are currently requiring greater than fluticasone 500 mcg bid plus Long-Acting Beta Agonists (LABA) one puff twice daily or its equivalent plus Long Acting Muscarinic Antagonists (LAMA) and/or individuals using oral corticosteroids daily or every other day for more than 14 days at the time of the Screening/Enrollment Visit 6. Are currently pregnant or lactating, or plan to become pregnant during the time of study participation. Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (i.e., oral subcutaneous, mechanical, or surgical contraception) 7. Have a known, pre-existing clinically important lung condition other than asthma. 8. Have a current malignancy or previous history of cancer in remission for less than 12 months prior to enrollment 9. Have a known immunodeficiency disease 10. Use of investigational drugs within 4 weeks of enrollment 11. Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study 12. If in the asthma group, will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow Protocol CAUSE-03 CHEETAH 13. If in the non-asthma group, having bronchodilator reversibility (improvement in Forced expiratory volume in 1 second (FEV1) with albuterol \> = 10%) at the Screening/Enrollment visit 14. Have had a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure. Potential participants may be reassessed as outlined in the Protocol CAUSE-03 Manual of Procedures (MOP)

Inclusion Criteria

Exclusion Criteria

1. Participant and/or parent guardian must be able to understand and provide informed consent and assent
2. Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Protocol CAUSE-03 Manual of Operations (MOP)
3. Either:
1. Have had a diagnosis of asthma made \> 1 year prior to recruitment; participants who received an asthma diagnosis by a clinician \<= 1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment (asthma group), or
2. No report of ever being diagnosed with asthma (non-asthma group)
4. Either:
1. Require at least Step 2 therapy at the Screening/Enrollment Visit (asthma group), or
2. Have not used any asthma medications in the prior year (non-asthma group)
5. Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to enrollment
6. Have documentation of current medical insurance with prescription coverage at the Screening/Enrollment Visit
7. Participant and/or parent guardian has a smartphone compatible with the study electronic Patient Reported Outcomes (ePRO) system, Medidata Patient Cloud, and is willing to download one application for study use

1. Parent or guardian is not able or willing to give written informed consent or comply with study protocol
2. Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study
3. Are currently receiving immunotherapy
4. Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to enrollment
5. Are currently requiring greater than fluticasone 500 mcg bid plus Long-Acting Beta Agonists (LABA) one puff twice daily or its equivalent plus Long Acting Muscarinic Antagonists (LAMA) and/or individuals using oral corticosteroids daily or every other day for more than 14 days at the time of the Screening/Enrollment Visit
6. Are currently pregnant or lactating, or plan to become pregnant during the time of study participation. Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (i.e., oral subcutaneous, mechanical, or surgical contraception)
7. Have a known, pre-existing clinically important lung condition other than asthma.
8. Have a current malignancy or previous history of cancer in remission for less than 12 months prior to enrollment
9. Have a known immunodeficiency disease
10. Use of investigational drugs within 4 weeks of enrollment
11. Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
12. If in the asthma group, will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow Protocol CAUSE-03 CHEETAH
13. If in the non-asthma group, having bronchodilator reversibility (improvement in Forced expiratory volume in 1 second (FEV1) with albuterol \> = 10%) at the Screening/Enrollment visit
14. Have had a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure. Potential participants may be reassessed as outlined in the Protocol CAUSE-03 Manual of Procedures (MOP)

Contacts and Locations

Principal Investigator

Andrew Liu, M.D.

STUDY_CHAIR

Children's Hospital Colorado: Allergy Program

Matthew C. Altman, M.D., M.Phil.

STUDY_CHAIR

Benaroya Research Institute at Virginia Mason: Systems Immunology Division

Study Locations (Sites)

Children's Hospital Colorado: Allergy Program

Aurora, Colorado, 80045

United States

Children's National Medical Center: Children's Research Institute

Washington, District of Columbia, 20010

United States

Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology

Chicago, Illinois, 60611

United States

Boston University School of Medicine: Pulmonary Center

Boston, Massachusetts, 02118

United States

Boston Children's Hospital: Department of Immunology

Boston, Massachusetts, 02215

United States

Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute

New York, New York, 10029

United States

Columbia University Medical Center: Division of Pediatric Pulmonology

New York, New York, 10032

United States

Cincinnati Children's Hospital Medical Center: Asthma Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Andrew Liu, M.D., STUDY_CHAIR, Children's Hospital Colorado: Allergy Program
Matthew C. Altman, M.D., M.Phil., STUDY_CHAIR, Benaroya Research Institute at Virginia Mason: Systems Immunology Division

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 Date2024-04-23

Study Completion Date2026-05-01

Study Record Updates

Study Start Date2024-04-23

Study Completion Date2026-05-01

Terms related to this study

Keywords Provided by Researchers

Asthma
Observational study
Children

Additional Relevant MeSH Terms

Asthma