NCT05835388

Brief Summary

This research registry and repository was designed because the investigators want to learn about how to improve the health and quality of life of older adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2019

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2023

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

4.8 years

First QC Date

April 18, 2023

Last Update Submit

May 6, 2024

Conditions

Keywords

Older adultsGenetic materialBiorepository

Outcome Measures

Primary Outcomes (1)

  • Collection of STARR repository data

    De-identified repository data and samples will be made available to outside investigators for future studies related to aging

    Baseline to one day

Secondary Outcomes (1)

  • KAPP Sen TMC repository data

    Baseline to one year

Study Arms (2)

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community dwelling adults from the South Texas area who are interested in volunteering for research studies on aging.

You may qualify if:

  • Age 18 years or older
  • Age 20 years and older

You may not qualify if:

  • Inability to provide informed consent
  • Pregnancy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and serum will be stored for future research after obtaining blood sugar level, and other measures such as lipids, liver and kidney function. Genetic material will be obtained from blood to provide the biology of aging and aging-related disorders. Fat samples collected from a biopsy for future genetic research. Skin tissue will be collected by a punch biopsy for future genetic research.

Study Officials

  • Sara Espinoza, MD

    University of Texas Health Science Center San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

April 28, 2023

Study Start

February 11, 2019

Primary Completion

December 6, 2023

Study Completion

December 6, 2023

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Requests from investigators to obtain data/specimens from the repository must be submitted in writing using an official repository request form, along with study protocol and documentation of appropriate approvals. Requests will be reviewed on a monthly basis by members of the Repository Executive Committee. Request to access data or specimens will be processed and entered into the Repository Log by the Repository Coordinator and submitted for review by the Executive Committee each month.

Locations