Clinical Diagnostic Approach for Cases of Thyroid Nodules

• ClinicalTrials.gov Identifier: NCT03884140
• Recruitment Status: Not yet recruiting
• First Posted: March 21, 2019
• Last Update Posted: June 27, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): amira hassan abd el Aziz, Assiut University

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
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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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.

Eligibility Criteria

• 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• no

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Publications:

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.

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.

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.

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.

• Responsible Party: amira hassan abd el Aziz, Assistant Lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT03884140
• Other Study ID Numbers: thyroid nodules
• First Posted: March 21, 2019
• Last Update Posted: June 27, 2019
• Last Verified: June 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, Assiut University:

Thyroid nodules; T.S.H; Thyroid US; FNAC

Additional relevant MeSH terms:

Thyroid Nodule; Thyroid Diseases; Endocrine System Diseases; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms