- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05835388
The South Texas Aging Registry and Repository (STARR)
The South Texas Aging Registry and Repository (STARR)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sara Espinoza, MD
- Phone Number: (210) 617-5197
- Email: espinozas2@uthscsa.edu
Study Contact Backup
- Name: Nicolas Musi, MD
- Phone Number: (210) 562-6140
- Email: Musi@uthscsa.edu
Study Locations
-
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Texas
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San Antonio, Texas, United States, 78229
- Recruiting
- The University of Texas Health Science Center at San Antonio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria STARR:
-Age 18 years or older
Inclusion Criteria KAPP Sen TMC:
-Age 20 years and older
Exclusion Criteria STARR:
- Inability to provide informed consent
- Pregnancy
Exclusion Criteria KAPP Sen Tissue Mapping Center (TMC) Study:
- Diabetes
- Hypertension with end-organ damage
- BMI>30
- GFR<60 ml/min/1.73 m2
- Cardiovascular disease
- Pancreatitis
- Malignancy other than non-melanoma skin cancers
- Active, uncontrolled pulmonary, hepatic, infectious, gastrointestinal, endocrine, neurologic, or inflammatory disease.
- Chronic use of systemic steroids or use of agents with senolytic activity
- Any disease or condition considered to be exclusionary based on the clinical option and discretion of PI
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Primary Study
Community dwelling adults from the South Texas area who are interested in volunteering for research studies on aging.
This will facilitate the inclusion of older adults and minority in research studies and help to increase the quantity and quality of research relating to them.
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KAPP Sen Tissue Mapping Study
The substudy KAPP Sen TMC will enroll eligible STARR participants to undergo repeat assessments over two years.
KAPP Sen TMC is a collaborative effort between UT Health San Antonio, Jackson Laboratory for Genomic Medicine (JAX-GM), Brigham and Women's Hospital, Joslin Diabetes Center, UConn Health Center on Aging and Mayo Clinic to characterize cellular senescence in terms of its presence and heterogeneity in healthy human tissues, as well as its tissue burden, spatial distribution, and biological features in a diverse study population.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Collection of STARR repository data
Time Frame: Baseline to one day
|
De-identified repository data and samples will be made available to outside investigators for future studies related to aging
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Baseline to one day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
KAPP Sen TMC repository data
Time Frame: Baseline to one year
|
Eligible STARR participants to undergo repeat assessments to characterize cellular senescence
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Baseline to one year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sara Espinoza, MD, University of Texas Health Science Center San Antonio
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC20150610H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
New prospective studies and those involving interacting with human subjects: Participants/research volunteers who agree to be re-contacted will be matched with future studies which they are likely to qualify for based upon information provided by each STARR participant at the time of enrollment and which is gathered using provided samples.
KAPP Sen TMC will support the use of a web-based platform to connect and facilitate entering, sharing, and exchanging data among collaborates. Data will be exported to a web portal developed in conjunction with the CODCC where the research community can request access to molecular data and corresponding biospecimen data, such as clinical, demographic, and biospecimen handling data.
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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