Clinical Diagnostic Approach for Cases of Thyroid Nodules

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03884140
Collaborator
(none)
1
36

Study Details

Study Description

Brief Summary

Thyroid nodules are a common presentation in the clinic, with an increasing incidence, especially in women. Their clinical significance is mainly related to excluding malignancy (4.0 to 6.5% of all thyroid nodules).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Thyroid nodule is a discrete lesion in the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma.

    Thyroid nodules are a common presentation in the clinic, with an increasing incidence, especially in women. The detection rate among healthy individuals is as high as 50%-60%, but the reported incidence of malignant nodules in all thyroid nodules has ranged from only 1.6%-12%.

    They are discovered either clinically on self-palpation by a patient, or during a physical examination by the clinician or incidentally during a radiologic procedure such as ultrasonography (US) imaging, computed tomography (CT) or magnetic resonance imaging (MRI) of the neck; with the increased use of sensitive imaging techniques, thyroid nodules are being diagnosed incidentally with increasing frequency in the recent years.

    Though thyroid nodules are common, their clinical significance is mainly related to excluding malignancy (4.0 to 6.5% of all thyroid nodules), evaluating their functional status and if they cause pressure symptoms.

    Thyroid nodules can be caused by many disorders:

    Benign (colloid nodule, Hashimoto's thyroiditis, simple or hemorrhagic cyst, follicular adenoma and subacute thyroiditis) and malignant (Papillary Cancer, Follicular Cancer, Hurthle Cell Cancer, Anaplastic Cancer, Medullary Cancer, Thyroid Lymphoma and metastases).

    Initial assessment of a patient found to have a thyroid nodule either clinically or incidentally should include a detailed and relevant history plus physical examination. Laboratory tests should begin with measurement of serum thyroid-stimulating hormone (TSH). Thyroid scintigraphy/radionuclide thyroid scan should be performed in patients presenting with a low serum TSH.

    Thyroid ultrasound should be performed in all those suspected or known to have a nodule to confirm the presence of a nodule, evaluate for additional nodules and cervical lymph nodes and assess for suspicious sonographic features.

    The next step in the evaluation of a thyroid nodule is a fine needle aspiration (FNA) biopsy, which is the gold standard diagnostic test.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Cross-Sectional
    Official Title:
    Clinical Diagnostic Evaluation of Thyroid Nodules
    Anticipated Study Start Date :
    Sep 1, 2019
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. correlation between clinical presentation and the results of diagnostic tools to reach to proper evaluation of thyroid nodules. [baseline]

      develop a rational, cost-effective approach to ordering and interpreting imaging and diagnostic tests in the evaluation of the thyroid nodule.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • all patient presented by thyroid nodules either discovered clinically or incidentally.
    Exclusion Criteria:
    • no

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    amira hassan abd el Aziz, Assistant Lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03884140
    Other Study ID Numbers:
    • thyroid nodules
    First Posted:
    Mar 21, 2019
    Last Update Posted:
    Jun 27, 2019
    Last Verified:
    Jun 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by amira hassan abd el Aziz, Assistant Lecturer, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 27, 2019