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

Telomere Length in Healthy Controls Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01982890
• Other study ID #: Telomeres and TREC
• Status: Enrolling by invitation
• Start date: January 4, 2005
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Telomere Length in Healthy Controls

Intervention

Other:
• Control
No intervention as this group is simply followed prospectively.

Locations

Country	Name	City	State
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Janssen, LP

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	At 3, 6, 9, 12, 18, 24, 36, 48 and 60 months
Secondary	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.	5 years