Clinical Diagnostic Approach for Cases of Thyroid Nodules

Thyroid Nodule Clinical Trial

Official title:

Clinical Diagnostic Evaluation of Thyroid Nodules

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03884140
• Other study ID #: thyroid nodules
• Status: Not yet recruiting
• Start date: September 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: June 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1
• Est. completion date: September 1, 2022
• Est. primary completion date: June 1, 2022
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• no

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Davies L, Welch HG. Current thyroid cancer trends in the United States. JAMA Otolaryngol Head Neck Surg. 2014 Apr;140(4):317-22. doi: 10.1001/jamaoto.2014.1. — View Citation

Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7. Erratum in: CA Cancer J Clin. 2014 Sep-Oct;64(5):364. — View Citation

Tamhane S, Gharib H. Retraction Note: Thyroid nodules update in diagnosis and management. Clin Diabetes Endocrinol. 2016 Apr 14;2:10. doi: 10.1186/s40842-016-0025-9. eCollection 2016. — View Citation

Tessler FN, Middleton WD, Grant EG, Hoang JK, Berland LL, Teefey SA, Cronan JJ, Beland MD, Desser TS, Frates MC, Hammers LW, Hamper UM, Langer JE, Reading CC, Scoutt LM, Stavros AT. ACR Thyroid Imaging, Reporting and Data System (TI-RADS): White Paper of the ACR TI-RADS Committee. J Am Coll Radiol. 2017 May;14(5):587-595. doi: 10.1016/j.jacr.2017.01.046. Epub 2017 Apr 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between clinical presentation and the results of diagnostic tools to reach to proper evaluation of thyroid nodules.	develop a rational, cost-effective approach to ordering and interpreting imaging and diagnostic tests in the evaluation of the thyroid nodule.	baseline