Thyroid NoduleNCT03884140
Clinical Diagnostic Approach for Cases of Thyroid Nodules
An observational study of Thyroid Nodule, run by Assiut University.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Nodule
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Sep 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: patients aged between 18-75 years presented by thyroid nodule either clinically or incidentally discovered coming to thyroid clinic for evaluation.
Who may be able to join
- all patient presented by thyroid nodules either discovered clinically or incidentally.
Who cannot join
- no
About this study
Official title: Clinical Diagnostic Evaluation of Thyroid Nodules
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).
Read the 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.
- Conditions
- Thyroid Nodule
- Keywords
- Thyroid nodules, T.S.H, Thyroid US, FNAC
- Medical subject headings
- Thyroid Nodule
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, amira hassan abd el Aziz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884140
- Sponsor's protocol ID
- thyroid nodules
- Status last verified
- Jun 2019
- First submitted
- 19 Mar 2019
- Last updated
- 27 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 28372962Tamhane 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.
PubMed 28707682Davies 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.
PubMed 24557566Siegel 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.
PubMed 24399786
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Diagnostic Evaluation of Thyroid Nodules
- ClinicalTrials.gov ID
- NCT03884140
- Acronym / sponsor ID
- thyroid nodules
- Conditions
- Thyroid Nodule
- Keywords
- Thyroid nodules, T.S.H, Thyroid US, FNAC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients aged between 18-75 years presented by thyroid nodule either clinically or incidentally discovered coming to thyroid clinic for evaluation.
Key inclusion criteria (1 listed)
- all patient presented by thyroid nodules either discovered clinically or incidentally.
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Background: PubMed 28372962Tessler 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.
- Background: PubMed 28707682Tamhane 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.
- Background: PubMed 24557566Davies 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.
- Background: PubMed 24399786Siegel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between clinical presentation and the results of diagnostic tools to reach to proper evaluation of thyroid nodules. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03884140, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.