Clinical trial NCT01982890: Telomeres and T-cell Receptor Excision Circles (TRECs) From Peripheral Blood in Normal Subjects Over Time
Official title: Telomere Shortening as a Prognostic Marker in Early Inflammatory Arthritis: Establishing the Stability of Telomeres in Normal Individuals
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Telomere Length in Healthy Controls
Keywords: Telomere length
Longitudinal observation
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2013-11-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Estimation of variability of multiple measures of the length of telomeres over one year
timeFrame: Over one year
Secondary outcomes:
measure: TREC numbers in peripheral blood over time
timeFrame: At 3, 6, 9, 12, 18, 24, 36, 48 and 60 months
measure: Estimation of the variability of the measure of length of telomeres with multiple measures over 5 years
timeFrame: 5 years
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Gilles Boire, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: