Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT01982890

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

No intervention as this group is simply followed prospectively.

Primary outcomes

  1. 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

Secondary outcomes

  1. TREC numbers in peripheral blood over time

    Time frame: At 3, 6, 9, 12, 18, 24, 36, 48 and 60 months

    Blood draws at these time points. T cell Excision Circles are measured from genomic DNA at the same time as is telomere length

  2. Estimation of the variability of the measure of length of telomeres with multiple measures over 5 years

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Janssen, LP

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2025
Study completion
2026
First posted
Nov 13, 2013
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.