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A Study of Patients With Chronic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04263727
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : April 11, 2023
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

Study Description
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Brief Summary:
TARGET-RWE is a 10-year, international, longitudinal, observational study of patients with chronic disease designed to specifically address important clinical questions that remain incompletely answered from registration trials. The protocol will follow a master protocol design in which a shared study infrastructure supports progressive development of the registry across the spectrum of chronic diseases.

Condition or disease
Asthma Chronic Obstructive Pulmonary Disease Idiopathic Pulmonary Fibrosis IPF COPD Respiratory Disease

Detailed Description:

The TARGET-RWE master protocol design allows shared study parameters and operational components to be organized within a centralized platform. Utilizing this platform, therapeutic area-aligned Communities with associated Disease-Specific Cohorts (DSC) can be added according to scientific merit and need to address specific research questions in patients diagnosed with chronic diseases. This design capitalizes on a shared, sustainable infrastructure across a diverse patient population, which allows for more efficient coordination and conduct than can be achieved in traditional stand-alone, independently-conducted research studies with narrowly-focused target patient populations. This master protocol design will ultimately support a dynamic program that adapts to the changing landscape of chronic disease management and allows for rapid enrollment and collection of retrospective and long-term prospective data from participants in specific disease areas of interest.

TARGET-RWE currently includes the TARGET-RWE.LUNG Community, with open DSCs for Asthma, COPD and Idiopathic Pulmonary Fibrosis.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: A Longitudinal Observational Study of Patients With Chronic Disease
Actual Study Start Date : February 27, 2020
Estimated Primary Completion Date : February 2035
Estimated Study Completion Date : February 2035

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Asthma
Non-Interventional. Patients with asthma will be screened and enrolled into the active Asthma disease-specific cohort.
Chronic Obstructive Pulmonary Disease (COPD)
Non-Interventional. Patients with COPD will be screened into the inactive COPD disease-specific cohort.
Idiopathic Pulmonary Fibrosis (IPF)
Non-Interventional. Patients with IPF will be screened into the inactive IPF disease-specific cohort.


Outcome Measures
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Primary Outcome Measures :
  1. Natural history of chronic disease under study: Characteristics of chronic diseases under study. [ Time Frame: Up to 10 years ]
  2. Natural history of chronic disease under study: Participant demographics [ Time Frame: Up to 10 years ]
  3. Natural history of chronic disease under study: Treatment use [ Time Frame: Up to 10 years ]
  4. Natural history of chronic disease under study: Disease progression [ Time Frame: Up to 10 years ]
  5. Adverse event frequency and severity [ Time Frame: Up to 10 years ]

Secondary Outcome Measures :
  1. Natural history of chronic disease under study: Treatment response [ Time Frame: Up to 10 years ]
  2. Time point of clinical response [ Time Frame: Every 12 months for 10 years ]
  3. Reasons for treatment discontinuation [ Time Frame: Up to 10 years ]
  4. Self-reported patient health measures: Asthma Control Test [ Time Frame: Every 12 months for 10 years ]

Biospecimen Retention:   Samples With DNA
Patients enrolled in TARGET-RWE may be invited to participate in the Biorepository Bank (BSB). Blood samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the participant's unique study ID number and the date the sample was obtained.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults and children with chronic disease in the United States and Europe.
Criteria

Inclusion Criteria:

  • Adults and children being managed or treated for a chronic disease under study. Diagnosis is based on the clinical judgement of the care provider.
  • Patient is anticipated to have continued management of their chronic disease at the participating site.

Exclusion Criteria:

  • Inability to provide informed assent/consent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04263727


Contacts
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Contact: Jenna Brininger 757-469-2574 jbrininger@targetrwe.com

Locations
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United States, Colorado
Asthma and Allergy Associates, PC Recruiting
Colorado Springs, Colorado, United States, 80907
United States, Florida
St. Francis Medical Institute Recruiting
Clearwater, Florida, United States, 33765
United States, Kentucky
Family Allergy & Asthma Research Institution Recruiting
Louisville, Kentucky, United States, 40215
United States, Michigan
University of Michigan Allergy Specialty Clinic & Food Allergy Recruiting
Ann Arbor, Michigan, United States, 48106
United States, North Carolina
Coastal Carolina Healthcare, P.A. Terminated
New Bern, North Carolina, United States, 28562
Sponsors and Collaborators
Target PharmaSolutions, Inc.
More Information
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Responsible Party: Target PharmaSolutions, Inc.
ClinicalTrials.gov Identifier: NCT04263727    
Other Study ID Numbers: TARGET-RWE
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: April 11, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Target PharmaSolutions, Inc.:
IPF
COPD
Respiratory Disease
Asthma
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Respiratory Tract Diseases
Respiration Disorders
 Chronic Disease
Lung Diseases
Fibrosis
Pathologic Processes
Disease Attributes
Lung Diseases, Interstitial