Skip to content

Telomeres and T-cell Receptor Excision Circles (TRECs) From Peripheral Blood in Normal Subjects Over Time

Telomere Shortening as a Prognostic Marker in Early Inflammatory Arthritis: Establishing the Stability of Telomeres in Normal Individuals

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01982890
Enrollment
200
Registered
2013-11-13
Start date
2005-01-04
Completion date
2026-12-31
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Telomere Length in Healthy Controls

Keywords

Telomere length, Longitudinal observation

Brief 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. 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.

Interventions

OTHERControl

No intervention as this group is simply followed prospectively.

Sponsors

Janssen, LP
CollaboratorINDUSTRY
Université de Sherbrooke
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Estimation of variability of multiple measures of the length of telomeres over one yearOver one yearBlood 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

Secondary

MeasureTime frameDescription
TREC numbers in peripheral blood over timeAt 3, 6, 9, 12, 18, 24, 36, 48 and 60 monthsBlood draws at these time points. T cell Excision Circles are measured from genomic DNA at the same time as is telomere length
Estimation of the variability of the measure of length of telomeres with multiple measures over 5 years5 yearsFrom 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026