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

NCT01982890 | Enrolling By Invitation

• 1 other identifier: Telomeres and TREC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Telomere Length in Healthy Controls

Keywords

Telomere length; Longitudinal observation

Outcome Measures

Primary Outcomes (1)

• 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

  Over one year

Secondary Outcomes (2)

• TREC numbers in peripheral blood over time

  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

  5 years

Study Arms (1)

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.

Other: Control

Interventions

Control OTHER

No intervention as this group is simply followed prospectively.

Normal human controls

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Janssen, LP: collaborator

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Genomic DNA extracted from peripheral blood

Study Officials

• Gilles Boire, MD, MSc

  Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 13, 2013
• Study Start: January 4, 2005
• Primary Completion: February 28, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

CA (1)