Telomere Length in Healthy ControlsNCT01982890
Telomeres and T-cell Receptor Excision Circles (TRECs) From Peripheral Blood in Normal Subjects Over Time
An observational study of Telomere Length in Healthy Controls, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The Investigators have established a cohort of patients with recent-onset inflammatory arthritis called Early Undifferentiated PolyArthritis (EUPA). This cohort was established to define novel biomarkers of poor outcomes. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Telomere Length in Healthy Controls
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jan 2005to 31 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal human controls apparied for gender and for groups of age with patients of the EUPA cohort (with inflammatory arthritis of between 1 and 12 months duration presenting for clinical care at the Rheumatology Division of the Centre hospitalier universitaire de Sherbrooke.)
Who may be able to join
- Healthy-for-age subjects, as defined by Absence of acute infectious, traumatic or immunologic disease; Absence of severe chronic diseases Age and sex concordant with the stratification of patients from a longitudinal cohort of early inflammatory arthritis (EUPA)
Who cannot join
- History of cancer (except a single episode of non-melanocytic skin cancer) Severe cardiovascular disease (i.e. difficult to control or requiring multiple drugs) Chronic infection Inflammatory arthritis Severe high blood pressure or diabetes (i.e. difficult to control or requiring multiple drugs) Any severe disease affecting function or difficult to control or requiring multiple drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Telomere Shortening as a Prognostic Marker in Early Inflammatory Arthritis: Establishing the Stability of Telomeres in Normal Individuals
The Investigators have established a cohort of patients with recent-onset inflammatory arthritis called Early Undifferentiated PolyArthritis (EUPA). This cohort was established to define novel biomarkers of poor outcomes. We want to study telomere length and T-cell Receptor Excision Circles (TREC) numbers in peripheral blood as new biomarkers.
This cohort of normal controls was established to be able to define the stability over short periods of time of telomere length and TREC numbers in normal individuals, in order to compare with arthritis patients.
Read the detailed description
It is difficult to establish early on the prognosis of patients with recent-onset polyarthritis. We want to know if we can use the length of telomeres in peripheral blood cells at baseline as a novel prognostic marker.
In order to be able to interpret our observations in arthritis patients over time, we need to compare these results with those observed in normal human controls adjusted for gender and for age groups.
These patients are first screened for the presence of acute or chronic severe diseases (cancer, cardiovascular, articular, et...). They then have genomic DNA extracted from peripheral blood at Baseline and at 3 months interval for a year than annually for a total duration of 5 years. A complete blood count is collected at each blood draw. At each blood draw, the appearance of acute or chronic diseases is noted.
- Conditions
- Telomere Length in Healthy Controls
- Being tested
- Control
- Keywords
- Telomere length, Longitudinal observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
No intervention as this group is simply followed prospectively.
| Study group | Role | What they receive |
|---|---|---|
| Normal human controls | Observational study. Subjects are screened for the absence of severe illnesses and followed prospectively with sequential blood draws, noting the occurence of acute and chronic severe illnesses.
Subjects are matched by age groups and sex with patients of the prospective cohort EUPA including patients with recent-onset inflammatory polyarthritis. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of variability of multiple measures of the length of telomeres over one year
Blood draws to collect genomic DNA both from total peripheral blood cells and from peripheral blood mononuclear cells are done at 0, 3, 6, 9 and 12 months (along with a complete blood count). At each time, patients are assessed for severe acute and chronic diseases
Measured: Over one year
Secondary outcomes (2)
TREC numbers in peripheral blood over time
Blood draws at these time points. T cell Excision Circles are measured from genomic DNA at the same time as is telomere length
Measured: At 3, 6, 9, 12, 18, 24, 36, 48 and 60 months
Estimation of the variability of the measure of length of telomeres with multiple measures over 5 years
From the end of the first year, patients will be followed yearly with an assessment of the occurence of new severe acute and chronic diseases and a blood draw to collect genomic DNA isolated from total blood cells and from isolated blood mononuclear cells, along with a complete blood count to assess lymphocyte numbers.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study start4 Jan 2005
- Primary completion28 Feb 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telomere Length in Healthy ControlsStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Responsible party
- Principal investigator, Gilles Boire, Université de Sherbrooke
- Investigators
- Gilles Boire, MD, MSc, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982890
- Sponsor's protocol ID
- Telomeres and TREC
- Status last verified
- Mar 2025
- First submitted
- 30 Oct 2013
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telomere Shortening as a Prognostic Marker in Early Inflammatory Arthritis: Establishing the Stability of Telomeres in Normal Individuals
- ClinicalTrials.gov ID
- NCT01982890
- Acronym / sponsor ID
- Telomeres and TREC
- Conditions
- Telomere Length in Healthy Controls
- Keywords
- Telomere length, Longitudinal observation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- 4 Jan 2005 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Nov 2013 (estimated)
- 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.
The Investigators have established a cohort of patients with recent-onset inflammatory arthritis called Early Undifferentiated PolyArthritis (EUPA). This cohort was established to define novel biomarkers of poor outcomes. We want to study telomere length and T-cell Receptor Excision Circles (TREC) numbers in peripheral blood as new biomarkers.
This cohort of normal controls was established to be able to define the stability over short periods of time of telomere length and TREC numbers in normal individuals, in order to compare with arthritis patients.
Detailed description
It is difficult to establish early on the prognosis of patients with recent-onset polyarthritis. We want to know if we can use the length of telomeres in peripheral blood cells at baseline as a novel prognostic marker.
In order to be able to interpret our observations in arthritis patients over time, we need to compare these results with those observed in normal human controls adjusted for gender and for age groups.
These patients are first screened for the presence of acute or chronic severe diseases (cancer, cardiovascular, articular, et...). They then have genomic DNA extracted from peripheral blood at Baseline and at 3 months interval for a year than annually for a total duration of 5 years. A complete blood count is collected at each blood draw. At each blood draw, the appearance of acute or chronic diseases is noted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal human controls | – | Other: ControlObservational study. Subjects are screened for the absence of severe illnesses and followed prospectively with sequential blood draws, noting the occurence of acute and chronic severe illnesses. Subjects are matched by age groups and sex with patients of the prospective cohort EUPA including patients with recent-onset inflammatory polyarthritis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal human controls apparied for gender and for groups of age with patients of the EUPA cohort (with inflammatory arthritis of between 1 and 12 months duration presenting for clinical care at the Rheumatology Division of the Centre hospitalier universitaire de Sherbrooke.)
Key inclusion criteria (1 listed)
- Healthy-for-age subjects, as defined by Absence of acute infectious, traumatic or immunologic disease; Absence of severe chronic diseases Age and sex concordant with the stratification of patients from a longitudinal cohort of early inflammatory arthritis (EUPA)
Key exclusion criteria (1 listed)
- History of cancer (except a single episode of non-melanocytic skin cancer) Severe cardiovascular disease (i.e. difficult to control or requiring multiple drugs) Chronic infection Inflammatory arthritis Severe high blood pressure or diabetes (i.e. difficult to control or requiring multiple drugs) Any severe disease affecting function or difficult to control or requiring multiple drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlNo intervention as this group is simply followed prospectively. | Other | Normal human controls |
Primary outcome
Estimation of variability of multiple measures of the length of telomeres over one year
Time frame: Over one year
Blood draws to collect genomic DNA both from total peripheral blood cells and from peripheral blood mononuclear cells are done at 0, 3, 6, 9 and 12 months (along with a complete blood count). At each time, patients are assessed for severe acute and chronic diseases
2 secondary outcomes
TREC numbers in peripheral blood over time
Time frame: At 3, 6, 9, 12, 18, 24, 36, 48 and 60 months
Estimation of the variability of the measure of length of telomeres with multiple measures over 5 years
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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.
Gilles Boire, MD, MSc principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
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 Telomere Length in Healthy Controls, run by Université de Sherbrooke at 1 site in Canada.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 25 Mar 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Estimation of variability of multiple measures of the length of telomeres over one year (time frame: Over one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2025.