Healthy AgingNCT05123859
Patterns of Natural Aging and the Role of Senescence Registry
An observational study of Healthy Aging, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a registry to identify changes in the expression of aging-related biomarkers, changes in functional performance, and/or changes in quality-of-life across the aging spectrum in 250 participants ≥ 25 years of age that will be conducted by the University of North Carolina. Read more about this study
- Who is it for?
- Ages 25 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2022to 14 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: "Healthy" adults age 18 to 85 who meet inclusion criteria and do not have exclusion criteria. It is a convenience sample.
Who may be able to join
- Adult participants (≥ 25 to ≤ 85 years)
- Participants must be capable and willing to provide IRB-approved written informed consent
- Participants must be willing and able to attend all in-person study visits and complete all study assessments and questionnaires
Who cannot join
- Autoimmune disorders
- Previous or currently undergoing chemotherapy, immunotherapy, or radiation therapy
- History of transplants, including solid organ or bone marrow transplants
- Presence of major active infection for which antibiotics and/or antivirals are prescribed within the last 14 days (chronic or acute, e.g., sepsis, HIV, pneumonia, active COVID infection)
- Dialysis
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Division of Oncology
Chapel Hill, North Carolina, 27599
About this study
This is a registry to identify changes in the expression of aging-related biomarkers, changes in functional performance, and/or changes in quality-of-life across the aging spectrum in 250 participants ≥ 25 years of age that will be conducted by the University of North Carolina. The primary purpose of this registry is to measure biomarkers of aging/senescence and build computational models of aging in order to better understand the role of senescence in aging-related functional decline and differences between aging in a general population vs cohorts enriched for aging related disease (cancer, heart disease). Aging biomarker data in cohorts with cancer and heart disease has already been collected; the current study will enroll participants into the cohort of aging in the general population (Aging Cohort).
Over the past century, life expectancy has increased by 30 years. With that gain has come a dramatic rise in age-related disease and an urgent need to understand, prevent, and treat these conditions. While age-related diseases have diverse phenotypes, there is increasing recognition of common biological underpinnings with cellular senescence as the nexus linking subcellular changes due to epigenetic changes, DNA damage, and mitochondria dysfunction with a decline in health due to multi-morbidity. The molecular changes that shift one's aging trajectory from a 'healthy' state to a 'disease' state are poorly understood; however, there is increasing evidence that senescence plays a key role in this shift. Computational models of natural aging and aging related disease are important tools in understanding the phenomenon of senescence, its regulation and dynamics, and its role in physiological or pathological processes during human aging. These findings will serve as pilot data for future analysis of cellular senescence, as measured by p16INK4 (hereafter referred to as p16) expression, and aging in other cohorts and begin to establish comparisons between p16 and other potentially clinically relevant aging biomarkers such as DNA methylation and plasma proteomics.
Read the detailed description
The primary purpose of this registry is to collect aging biomarker data in a general population across the entire lifespan (Aging Cohort). The investigators will then build several computational models of aging in order to better understand senescence in the context of general aging or specific aging associate diseases. As a secondary goal, The investigators will determine the association between biomarkers of aging and health characteristics (defined through blood chemistry panels and specific functional measures). Central to these computational models is the measurement of a biomarker of aging/senescence, p16INK4 (hereafter referred to as p16) in peripheral blood T cells. The primary aim of this registry is to determine if p16 mRNA expression measured in T cells reflects total organismal senescent load. The secondary aim is to determine if senescence dynamics are affected by age-associated chronic diseases. The exploratory aim is to determine the ability of computational models of senescence to predict clinical and functional status. Active participation in the study will end at the completion of the study questionnaires and assessments, but The investigators will ask permission to recontact participants at a later date for longitudinal sample collection.
Despite the prominence of senescence as an aging mechanism and target of geroscience-based therapies, little is known about the dynamics of senescent cells in humans. Understanding the process of senescence, including its regulation, dynamics, and contribution to physiologic or pathologic processes, is essential for an understanding of aging.
In this registry, the investigators will assess the contribution of senescence, co-morbidities, functional performance, and quality of life to aging. The investigators will determine the ability of these factors to aid in the development of a new stochastic model that will be formulated specifically in the context of T-cell turnover and senescence, thereby providing a cell level description of p16 accumulation and a mechanistic model with parameters characterizing relevant physiological processes. The development of this new model will thus enable a quantitative, predictive, mechanistic study of the role of senescence in aging at both organismal and cellular levels
- Conditions
- Healthy Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| age groups | * A total of 30 participants in the 25- to 34-year age group * A total of 45 participants in the 35- to 44-year age group * A total of 50 participants in the 45- to 54-year age group * A total of 50 participants in the 55- to 64-year age group * A total of 45 participants in the 65- to 74-year age group * A total of 30 participants in the 75- to 85-year age group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Organismal Senescent Load Using Measures of p16 mRNA in T cells
The purpose of this registry is to collect aging biomarker data in a general population across the entire lifespan (Aging Cohort) to build several computational models of aging in order to better understand senescence in the context of general aging or specific aging associated diseases. Data collected following informed consent. Participants provide 1 time only blood sample and answer questionnaires; no follow up.
Measured: a total of approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start5 Jan 2022
- Primary completion14 Aug 2022
- Study completion14 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Institute of Technology, Sapere Bio
- Responsible party
- Sponsor
- Investigators
- Hyman Muss, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123859
- Sponsor's protocol ID
- 21-2153
- Status last verified
- Aug 2022
- First submitted
- 21 Oct 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsygankov D, Liu Y, Sanoff HK, Sharpless NE, Elston TC. A quantitative model for age-dependent expression of the p16INK4a tumor suppressor. Proc Natl Acad Sci U S A. 2009 Sep 29;106(39):16562-7. doi: 10.1073/pnas.0904405106. Epub 2009 Sep 14.
PubMed 19805338
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Natural Aging and the Role of Senescence Registry
- ClinicalTrials.gov ID
- NCT05123859
- Acronym / sponsor ID
- 21-2153
- Conditions
- Healthy Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Georgia Institute of Technology, Sapere Bio
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 14 Aug 2022 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a registry to identify changes in the expression of aging-related biomarkers, changes in functional performance, and/or changes in quality-of-life across the aging spectrum in 250 participants ≥ 25 years of age that will be conducted by the University of North Carolina. The primary purpose of this registry is to measure biomarkers of aging/senescence and build computational models of aging in order to better understand the role of senescence in aging-related functional decline and differences between aging in a general population vs cohorts enriched for aging related disease (cancer, heart disease). Aging biomarker data in cohorts with cancer and heart disease has already been collected; the current study will enroll participants into the cohort of aging in the general population (Aging Cohort).
Over the past century, life expectancy has increased by 30 years. With that gain has come a dramatic rise in age-related disease and an urgent need to understand, prevent, and treat these conditions. While age-related diseases have diverse phenotypes, there is increasing recognition of common biological underpinnings with cellular senescence as the nexus linking subcellular changes due to epigenetic changes, DNA damage, and mitochondria dysfunction with a decline in health due to multi-morbidity. The molecular changes that shift one's aging trajectory from a 'healthy' state to a 'disease' state are poorly understood; however, there is increasing evidence that senescence plays a key role in this shift. Computational models of natural aging and aging related disease are important tools in understanding the phenomenon of senescence, its regulation and dynamics, and its role in physiological or pathological processes during human aging. These findings will serve as pilot data for future analysis of cellular senescence, as measured by p16INK4 (hereafter referred to as p16) expression, and aging in other cohorts and begin to establish comparisons between p16 and other potentially clinically relevant aging biomarkers such as DNA methylation and plasma proteomics.
Detailed description
The primary purpose of this registry is to collect aging biomarker data in a general population across the entire lifespan (Aging Cohort). The investigators will then build several computational models of aging in order to better understand senescence in the context of general aging or specific aging associate diseases. As a secondary goal, The investigators will determine the association between biomarkers of aging and health characteristics (defined through blood chemistry panels and specific functional measures). Central to these computational models is the measurement of a biomarker of aging/senescence, p16INK4 (hereafter referred to as p16) in peripheral blood T cells. The primary aim of this registry is to determine if p16 mRNA expression measured in T cells reflects total organismal senescent load. The secondary aim is to determine if senescence dynamics are affected by age-associated chronic diseases. The exploratory aim is to determine the ability of computational models of senescence to predict clinical and functional status. Active participation in the study will end at the completion of the study questionnaires and assessments, but The investigators will ask permission to recontact participants at a later date for longitudinal sample collection.
Despite the prominence of senescence as an aging mechanism and target of geroscience-based therapies, little is known about the dynamics of senescent cells in humans. Understanding the process of senescence, including its regulation, dynamics, and contribution to physiologic or pathologic processes, is essential for an understanding of aging.
In this registry, the investigators will assess the contribution of senescence, co-morbidities, functional performance, and quality of life to aging. The investigators will determine the ability of these factors to aid in the development of a new stochastic model that will be formulated specifically in the context of T-cell turnover and senescence, thereby providing a cell level description of p16 accumulation and a mechanistic model with parameters characterizing relevant physiological processes. The development of this new model will thus enable a quantitative, predictive, mechanistic study of the role of senescence in aging at both organismal and cellular levels
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| age groups | – | –* A total of 30 participants in the 25- to 34-year age group * A total of 45 participants in the 35- to 44-year age group * A total of 50 participants in the 45- to 54-year age group * A total of 50 participants in the 55- to 64-year age group * A total of 45 participants in the 65- to 74-year age group * A total of 30 participants in the 75- to 85-year age group |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- "Healthy" adults age 18 to 85 who meet inclusion criteria and do not have exclusion criteria. It is a convenience sample.
Key inclusion criteria (3 listed)
- Adult participants (≥ 25 to ≤ 85 years)
- Participants must be capable and willing to provide IRB-approved written informed consent
- Participants must be willing and able to attend all in-person study visits and complete all study assessments and questionnaires
Key exclusion criteria (6 listed)
- Autoimmune disorders
- Previous or currently undergoing chemotherapy, immunotherapy, or radiation therapy
- History of transplants, including solid organ or bone marrow transplants
- Presence of major active infection for which antibiotics and/or antivirals are prescribed within the last 14 days (chronic or acute, e.g., sepsis, HIV, pneumonia, active COVID infection)
- Dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Organismal Senescent Load Using Measures of p16 mRNA in T cells
Time frame: a total of approximately 1 hour
The purpose of this registry is to collect aging biomarker data in a general population across the entire lifespan (Aging Cohort) to build several computational models of aging in order to better understand senescence in the context of general aging or specific aging associated diseases. Data collected following informed consent. Participants provide 1 time only blood sample and answer questionnaires; no follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Results publication: PubMed 19805338Tsygankov D, Liu Y, Sanoff HK, Sharpless NE, Elston TC. A quantitative model for age-dependent expression of the p16INK4a tumor suppressor. Proc Natl Acad Sci U S A. 2009 Sep 29;106(39):16562-7. doi: 10.1073/pnas.0904405106. Epub 2009 Sep 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyman Muss, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aging, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Organismal Senescent Load Using Measures of p16 mRNA in T cells (time frame: a total of approximately 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05123859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.