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Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort (ChewingHort)

Primary Purpose

Horton Disease

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
chewing gum
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Horton Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Group 1
  • Any patient suspected of having GCA, that is to say in practice patients in whom a doctor plans a Doppler ultrasound of temporal arteries or a temporal arteritis biopsy or an imagery (Angio-CT, Angio-MRI, PET- to scan
  • Patient over 50 years old
  • Patient able to chew a chewing gum for 4 minutes Group 2
  • Patients free from GCA
  • Age matched (± 3 years)
  • Patient able to chew a chewing gum for 4 minutes

Exclusion Criteria:

  • Group 1
  • Patients known to have a temporomandibular joint pathology
  • Patients who started corticosteroid therapy Group 2
  • Patients known to have temporomandibular joint pathology
  • Patients who started corticosteroid therapy

Sites / Locations

  • CH Avignon
  • CHU Limoges
  • CHU de Nantes
  • CH St Antoine
  • CHU Tours
  • CH Valenciennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Horton group

N Horton Group

Arm Description

The test involves chewing a chewing gum for 4 minutes plus a standard Horton disease diagnostic

The test involves chewing a chewing gum for 4 minutes

Outcomes

Primary Outcome Measures

Evaluate the sensitivity and specificity of the chewing gum test in Horton's disease.
Determination of: True positive: Sick people correctly identified as sick False positive: Healthy people incorrectly identified as sick True negative: Healthy people correctly identified as healthy False negative: Sick people incorrectly identified as healthy Then wa calculate: the number true positives TP the number of false positives FP the number of true negatives TN the number of false negatives.FN Specificty= TN/(TN+FP) Sensitivity= : TP/(TP+FN) The test is performed twice an hour apart, to verify its reproducibility, before the introduction of corticosteroid therapy, with chewing gums without sugar.

Secondary Outcome Measures

Evaluate the positive predictive value, the negative predictive value, and the likelihood ratio of the chewing gum test in Horton's disease,
predictive value= TP/(TP+FP)

Full Information

First Posted
June 27, 2019
Last Updated
November 16, 2021
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT04010097
Brief Title
Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort
Acronym
ChewingHort
Official Title
Evaluation of Sensitivity, Specificity, Positive and Negative Predictive Values of the Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
It is hypothesized that chewing-gums may be a useful test to unmask jaws intermittent claudication in order to enhance the diagnosis of Giant Cell Arteritis (GCA).
Detailed Description
GCA is the most common vasculitis. The diagnosis easily could be made in patients over 50 years old with headache, inflammatory belt pain, claudication of the jaws, scalp hyperesthesia, ophthalmological manifestations and an inflammatory syndrome. However, the clinical pictures could be less suggestive, hence diagnostic difficulties. Some patients have only isolated inflammatory syndrome. To confirm the diagnosis, sometimes PET CT or temporal artery biopsy is used, but access to a PET CT is sometimes complex, biopsy of temporal arteries is only positive in about 70% cases. Early diagnosis is important, however, to avoid irreversible complications, especially ophthalmological complications. One in six patients has definitive amaurosis, because of diagnosis delay. The current diagnostic delay is estimated on average at 9 weeks. Jaw intermittent claudication probably has a very good positive predictive value and this clinical sign often carries conviction. Patients with claudication of the jaws also have a greater visual risk. Kuo reports two observations of patients with claudication of the jaws revealed by the "chewing gum test" after 2 minutes of chewing. It is therefore proposed to perform a chewing gum test to assess the sensitivity and specificity of this test, compared to the interview. Once the test is done, the study is completed for the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Horton Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Horton group
Arm Type
Experimental
Arm Description
The test involves chewing a chewing gum for 4 minutes plus a standard Horton disease diagnostic
Arm Title
N Horton Group
Arm Type
Active Comparator
Arm Description
The test involves chewing a chewing gum for 4 minutes
Intervention Type
Other
Intervention Name(s)
chewing gum
Intervention Description
The test involves chewing a chewing gum for 4 minutes
Primary Outcome Measure Information:
Title
Evaluate the sensitivity and specificity of the chewing gum test in Horton's disease.
Description
Determination of: True positive: Sick people correctly identified as sick False positive: Healthy people incorrectly identified as sick True negative: Healthy people correctly identified as healthy False negative: Sick people incorrectly identified as healthy Then wa calculate: the number true positives TP the number of false positives FP the number of true negatives TN the number of false negatives.FN Specificty= TN/(TN+FP) Sensitivity= : TP/(TP+FN) The test is performed twice an hour apart, to verify its reproducibility, before the introduction of corticosteroid therapy, with chewing gums without sugar.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Evaluate the positive predictive value, the negative predictive value, and the likelihood ratio of the chewing gum test in Horton's disease,
Description
predictive value= TP/(TP+FP)
Time Frame
Day1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Group 1 Any patient suspected of having GCA, that is to say in practice patients in whom a doctor plans a Doppler ultrasound of temporal arteries or a temporal arteritis biopsy or an imagery (Angio-CT, Angio-MRI, PET- to scan Patient over 50 years old Patient able to chew a chewing gum for 4 minutes Group 2 Patients free from GCA Age matched (± 3 years) Patient able to chew a chewing gum for 4 minutes Exclusion Criteria: Group 1 Patients known to have a temporomandibular joint pathology Patients who started corticosteroid therapy Group 2 Patients known to have temporomandibular joint pathology Patients who started corticosteroid therapy
Facility Information:
Facility Name
CH Avignon
City
Avignon
Country
France
Facility Name
CHU Limoges
City
Limoges
Country
France
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Name
CH St Antoine
City
Paris
Country
France
Facility Name
CHU Tours
City
Tours
Country
France
Facility Name
CH Valenciennes
City
Valenciennes
Country
France

12. IPD Sharing Statement

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Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort

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