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Intermountain INSPIRE Registry

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ClinicalTrials.gov Identifier: NCT02450006
Recruitment Status : Recruiting
First Posted : May 21, 2015
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

Study Description
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Brief Summary:
To collect biological samples, clinical information and laboratory data from patients diagnosed with any healthcare-related conditions who are seen at facilities affiliated with Intermountain Healthcare, including patients and their family members, and to collect the same information and samples from a general population including disease-free subjects.

Condition or disease
Condition

Detailed Description:

This is an observational, non-randomized, open, long-term project to collect a variety of biological samples, in addition to usual or specialized care clinical information and laboratory test results, from patients who present to Intermountain Healthcare-affiliated facilities, with symptoms of any healthcare-related conditions, as well as from a general population including disease-free subjects. The INSPIRE Registry will include all subjects enrolled in the HHD registry (IRB # 1007406, approval date 01- 16-2009) and the cathlab database registry (IRB # 1008366, approval date 10/04/2000), as of IRB approval date of this INSPIRE amended protocol.

Since this is a registry database project, there are no investigational treatments, drugs or procedures associated with participation. Information obtained from this registry project will not have direct or immediate benefit for any of the participants.

Biological samples and subject information will be obtained during diagnostic procedures and/or treatment that are generally part of usual or specialized care for the underlying healthcare-related condition. Sample testing and registry data utilization for various research projects can be initiated only after the appropriate approval is obtained from a registry oversight/management committee, and when appropriate, the Institutional Review Board.

After informed consent is obtained from the patient, the biological samples will be obtained in one of the following ways:

  1. During a procedure from access lines inserted for the procedure, or
  2. When other ordered lab work is done, or
  3. As a separate sample collection if no other lab work is planned. Biological sample collection from the general population may be a separate blood draw and/or sample collection. Participating patients may be asked to provide one or more collections of biological samples. Biological samples may be used in current and future research tests multiple times, or until the sample is consumed. In addition, participating subjects may be asked to complete the IRBreviewed questionnaires.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 50 Years
Official Title: INtermountain Healthcare Biological Samples Collection Project and Investigational REgistry for the On-going Study of Disease Origin, Progression and Treatment (Intermountain INSPIRE Registry)
Study Start Date : April 2015
Estimated Primary Completion Date : April 2050
Estimated Study Completion Date : April 2050
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA

Examples of the biological samples that may be collected are as follows (but not limited to):

  • Blood/Plasma
  • Bone Marrow
  • Buccal smear (cheek)
  • Cartilage
  • Cerebrospinal fluid
  • Mucus
  • Saliva
  • Sputum
  • Stool
  • Sweat
  • Synovial fluid
  • Tears
  • Tissue samples (e.g. muscle, skin, nails, tumor, etc)
  • Urine
  • Seminal fluid
  • Genetic material extracted from any biological sample
  • Other biological samples as identified by the Principal Investigator or Co-Investigators and agreed by the patient.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with any healthcare-related conditions who are seen at facilities affiliated with Intermountain Healthcare, including patients and their family members, the general population, including disease-free subjects.
Criteria

Inclusion Criteria:

  • Males or females of any age, any ethnicity, diagnosed with any healthcare-related conditions, presenting to an Intermountain Healthcare-affiliated facility or males or females of any age, any ethnicity, with or without any healthcare-related conditions, including disease-free subjects, from a general population that may include unaffected family members
  • Patient or patient's representative has the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures, using a form that is approved by the applicable IRB.

Exclusion Criteria:

  • Inability or refusal of the patient and/or the patient's legally-acceptable representative to provide informed consent for any reason.
  • Other conditions that in the opinion of the Principal Investigator or Co-Investigator(s) may increase risk to the subject and/or compromise the quality of the registry project.
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): NCT02450006


Contacts
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Contact: Joseph B Muhlestein, MD 801-507-4701 brent.muhlestein@imail.org
Contact: Patti Spencer 801-507-4778 patti.spencer@imail.org

Locations
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United States, Utah
Intermountain Medical Center and Intermountain Clinics Recruiting
Murray, Utah, United States, 84143
Contact: Joseph B Muhlestein, MD    801-507-4701    brent.muhlestein@imail.org   
Contact: Patti Spencer    801-507-4778    patti.spencer@imail.org   
Sponsors and Collaborators
Intermountain Health Care, Inc.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT02450006    
Other Study ID Numbers: 1024811
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022