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

Horton Disease Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04010097
• Other study ID #: 87RI19_0009
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: November 2021
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Horton Disease
• Polymyalgia Rheumatica

Intervention

Other:
• chewing gum
The test involves chewing a chewing gum for 4 minutes

Locations

Country	Name	City	State
France	CH Avignon	Avignon
France	CHU Limoges	Limoges
France	CHU de Nantes	Nantes
France	CH St Antoine	Paris
France	CHU Tours	Tours
France	CH Valenciennes	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	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)	Day1