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Clinical Diagnostic Approach for Cases of Thyroid Nodules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03884140
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : June 27, 2019
Information provided by (Responsible Party):
amira hassan abd el Aziz, Assiut University

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
Thyroid Nodule

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 6 Months
Official Title: Clinical Diagnostic Evaluation of Thyroid Nodules
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Primary Outcome Measures :
  1. correlation between clinical presentation and the results of diagnostic tools to reach to proper evaluation of thyroid nodules. [ Time Frame: baseline ]
    develop a rational, cost-effective approach to ordering and interpreting imaging and diagnostic tests in the evaluation of the thyroid nodule.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
patients aged between 18-75 years presented by thyroid nodule either clinically or incidentally discovered coming to thyroid clinic for evaluation.

Inclusion Criteria:

  • all patient presented by thyroid nodules either discovered clinically or incidentally.

Exclusion Criteria:

  • no
Additional Information:

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Responsible Party: amira hassan abd el Aziz, Assistant Lecturer, Assiut University Identifier: NCT03884140    
Other Study ID Numbers: thyroid nodules
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: June 27, 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
Keywords provided by amira hassan abd el Aziz, Assiut University:
Thyroid nodules
Thyroid US
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms