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Trial record 16 of 130 for:    GCA

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

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

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.


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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

Resource links provided by the National Library of Medicine


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




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)



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010097


Contacts
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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
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France
CHU Limoges Recruiting
Limoges, France
Contact: Guillaume Gondran, MD       guillaume.gondran@chu-limoges.fr   
Sponsors and Collaborators
University Hospital, Limoges

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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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