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

• ClinicalTrials.gov Identifier: NCT04010097
• Recruitment Status: Recruiting
• First Posted: July 8, 2019
• Last Update Posted: December 13, 2019
• Sponsor: University Hospital, Limoges
• Information provided by (Responsible Party): University Hospital, Limoges

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).

Condition or disease	Intervention/treatment	Phase
Horton Disease	Other: chewing gum	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 66 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: October 30, 2019
• Estimated Primary Completion Date: January 1, 2021
• Estimated Study Completion Date: June 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Horton group; The test involves chewing a chewing gum for 4 minutes plus a standard Horton disease diagnostic	Other: chewing gum; The test involves chewing a chewing gum for 4 minutes
Active Comparator: N Horton Group; The test involves chewing a chewing gum for 4 minutes	Other: chewing gum; The test involves chewing a chewing gum for 4 minutes

Outcome Measures

Primary Outcome Measures :

1. Evaluate the sensitivity and specificity of the chewing gum test in Horton's disease. [ Time Frame: Day 1 ]

   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 :

1. Evaluate the positive predictive value, the negative predictive value, and the likelihood ratio of the chewing gum test in Horton's disease, [ Time Frame: Day1 ]
   predictive value= TP/(TP+FP)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Guillaume GONDRAN, MD; 05 55 05 80 76; guillaume.gondran@chu-limoges.fr

Contact: Stéphanie DUMONTEIL; 05 55 05 80 76; stephanie.dumonteil@chu-limoges.fr

Locations

France

CHU Limoges; Recruiting

Limoges, France

Contact: Guillaume Gondran, MD guillaume.gondran@chu-limoges.fr

Sponsors and Collaborators

University Hospital, Limoges

More Information

• Responsible Party: University Hospital, Limoges
• ClinicalTrials.gov Identifier: NCT04010097 History of Changes
• Other Study ID Numbers: 87RI19_0009
• First Posted: July 8, 2019
• Last Update Posted: December 13, 2019
• Last Verified: June 2019

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

Additional relevant MeSH terms:

Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Skin Diseases, Vascular; Skin Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases