Study of the T CD8 Immune Response in Horton's Disease (Horton CD8)

March 10, 2026 updated by: Centre Hospitalier Universitaire Dijon

The research hypothesis is that T lymphocytes CD8 play a role in the physiopathology of Horton's disease.

At the inclusion visit, patients will have, as is the case in the usual strategy:

  • A complete clinical examination carried out by the doctor in charge of the patient
  • ESR, and CRP and fibrinogen assay
  • A full blood count for leukocytes and lymphocytes
  • A biopsy of the temporal artery (TAB) to screen for signs of vascularitis, suggesting Horton's disease. The clinician in charge of the patient will decide if a second biopsy is necessary. The biopsy will be sent to and analysed at Anatomy and Pathological cytology service. Immunohistochemical analyses will be done if the TAB is positive.

In addition to the standard clinical examination and complementary examinations relative to the patients' pathology, the following will be done:

  • Lymphocyte immunophenotyping for the quantity of T CD4 (cluster of differentiation 4) and CD8 lymphocytes, B lymphocytes and natural killer lymphocytes. This will make it possible to calculate the absolute value for different T lymphocyte populations.
  • A blood sample drawn into a dry 5 mL tube (large yellow) to isolate the serum, which will be stored at -80°C for future assays for cytokines and other biomarkers of interest for Horton's disease.
  • 16 blood samples drawn into 6 mL heparinized tubes (large green). These will be used immediately for cytometric and functional analyses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • Chu de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients presenting Horton's disease at the diagnosis before any treatment

Description

Inclusion Criteria:

Patients

  • Patients who have provided written informed consent
  • Patients covered by national health insurance
  • Age > 50 years
  • Patients with Horton's disease at the diagnosis before any treatment

Horton's disease is defined by American College of Rheumatology criteria, the diagnosis is made if any 3 of the following 5 criteria are associated:

  • age at the onset of the disease 50 years or above
  • recent onset localised headache
  • indurated temporal artery or decrease/absence of temporal pulse
  • erythrocyte sedimentation rate (ESR) above 50 mm for the first hour (or CRP>20 mg/L)
  • positive TAB showing vascularitis with infiltration of mononucleated cells or granulomatous inflammation with or without giant cells.

Controls Controls will be healthy volunteers recruited from blood donors of Dijon CHU, voluntary hospital personnel (nurses, doctors, laboratory technicians and secretaries) and patients without infectious or inflammatory disease, cancer or auto-immune disease (CRP<5mg/L) recruited in the department of the investigators at Dijon CHU. They will be matched for age and sex.

  • Age > 50 years
  • Patients covered by national health insurance
  • who have provided written informed consent to take part
  • Absence of inflammatory syndrome (CRP<5 mg /L)

Exclusion Criteria:

  • Any patient not meeting inclusion criteria
  • Patient treated with corticoids or immunosuppressants in the month preceding inclusion
  • Patients treated with chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Controls
Other: Blood sample drawn into a 5 mL dry tube
Other: 16 blood samples drawn into 6 mL heparinized tubes
Patients with HD
Other: Blood sample drawn into a 5 mL dry tube at the diagnosis and after 3 months of treatment
Other: 16 blood samples drawn into 6 mL heparinized tubes at the diagnosis and after 3 months of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of cytotoxic T lymphocytes CD8 (CD8+perforin+granzyme B+)
Time Frame: Change from baselines the percentage of cytotoxic T lymphocytes CD8 at 3 months of treatment
Change from baselines the percentage of cytotoxic T lymphocytes CD8 at 3 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2013

Primary Completion (Actual)

January 25, 2016

Study Completion (Actual)

January 25, 2016

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimated)

June 6, 2014

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAMSON APJ 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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