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Thyroid NoduleNCT04904159

Scoring System for Thyroid Gland Pathologies

An observational study of Thyroid Nodule and Thyroid Cancer, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Although anamnesis and physical examination remain the place in the evaluation of patients today; laboratory values, imaging methods and pathology results have come to the fore in the decision-making of surgery for patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Nodule, Thyroid Cancer
What is being tested?
Thyroidectomy and Lobectomy
Type of treatment
Surgery or procedure
How many people
300 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2021to 1 May 2023
How long will I take part?
24 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Thyroidectomy, which is a routine operation in clinic ( unilateral, total, complementary, etc.) ) applied patients will be included in the study

Who may be able to join

  • patients who undergone surgery for thyroid gland pathologies

Who cannot join

  • patients who did not want to be involved in the study
  • patients who missed in the follow-up period
  • pregnant patients

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Kartal Dr Lutfi Kirdar Tranining and Research Hospital

    Istanbul, 34890

Other trials in Turkey (Türkiye)

About this study

Official title: A New Scoring System in the Diagnosis of Thyroid Gland Pathologies

Although anamnesis and physical examination remain the place in the evaluation of patients today; laboratory values, imaging methods and pathology results have come to the fore in the decision-making of surgery for patients. As a result of all other criteria, a follow-up decision can be changed in a patient with a single fine needle aspiration biopsy result, or despite all the examinations the investigators have, a clear result cannot be achieved, and patient management may be disrupted. A holistic approach to thyroid gland pathologies is planned thanks to the scoring system that will be created in this study.

Read the detailed description

In routine clinical practice, the criteria the investigators consider during the pre - op period in patients evaluated due to thyroid pathologies include anamnesis, physical examination, laboratory values, especially thyroid function, thyroid-neck ultrasonographies, fine needle aspiration biopsies, according to which decisions about operation or nonoperative follow-up are made with the patient. The investigators aim to create a common scoring system by taking into account the pathology results of patients who have undergone thyroidectomy and comparing these results with the results of pre-op examination and thus to address patient management in a more objective and comprehensive way.

Being tested
Thyroidectomy, Lobectomy
Keywords
TI-RADS, Bethesda
Medical subject headings
Thyroid Nodule, Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThyroidectomyProcedure or surgery

    total thyroidectomy

  • LobectomyProcedure or surgery

    Lobectomy

Study groups in NCT04904159
Study groupRoleWhat they receive
BenignPatients who have benign pathologies after thyroidectomy
Receives: Procedure: Lobectomy
MalignPatients who have malign pathologies after thyroidectomy
Receives: Procedure: Thyroidectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Age

    Years

    Measured: Before Surgery

  2. Gender

    Male - Female

    Measured: Before Surgery

  3. Smoking Status

    Yes or No

    Measured: Before Surgery

  4. Radiation to the Neck Area

    Yes or No

    Measured: Before Surgery

  5. History of Thyroiditis

    Yes or No

    Measured: Before Surgery

  6. Family History

    Presence of family members with any thyroid pathologies especially thyroid cancer

    Measured: Before Surgery

  7. Complaint

    Months

    Measured: Before Surgery

  8. Thyroid Imaging Reporting and Data System ( TIRADS ) score

    Radiological features of throid nodule ( minimum value is 1 maximum value is 5 ); thyroid nodule which has a higher value means a worse outcome

    Measured: Before surgery

  9. Bethesda classification system for thyroid fine needle aspirates

    Histopathological features of thyroid nodule ( minimum value is 1 maximum value is 6 ) thyroid nodule which has higher value means a worse outcome

    Measured: Before surgery

  10. Thyroid Stimulating Hormone ( TSH ) levels

    it is a hormone secreted from the pituitary gland and triggers the functioning of the thyroid gland ( cut of values are 0.5 - 5.0 mIU / L )

    Measured: Before surgery

  11. Pathology results

    The result of the throid gland part sent to the pathology unit after surgery ( the results can be benign or malign )

    Measured: Immediately after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2021
  2. Study start1 May 2021
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion1 May 2023 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04904159
Sponsor's protocol ID
2021/514/198/20
Status last verified
May 2021
First submitted
17 May 2021
Last updated
1 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Macias CA, Arumugam D, Arlow RL, Eng OS, Lu SE, Javidian P, Davidov T, Trooskin SZ. A risk model to determine surgical treatment in patients with thyroid nodules with indeterminate cytology. Ann Surg Oncol. 2015 May;22(5):1527-32. doi: 10.1245/s10434-014-4190-8. Epub 2014 Nov 12.

    PubMed 25388058

  • Ianni F, Pascucci D, Paragliola RM, Rota CA, Perotti G, Fadda G, Pontecorvi A, Corsello SM. Follow-Up or Surgery for Indeterminate Thyroid Nodules: Could the CUT Score Application Be a Support for Decision-Making in the Preoperative Assessment? Thyroid. 2020 Jan;30(1):65-71. doi: 10.1089/thy.2018.0649. Epub 2019 Oct 23.

    PubMed 31552809

  • Sparano C, Verdiani V, Pupilli C, Perigli G, Badii B, Vezzosi V, Mannucci E, Maggi M, Petrone L. Choosing the best algorithm among five thyroid nodule ultrasound scores: from performance to cytology sparing-a single-center retrospective study in a large cohort. Eur Radiol. 2021 Aug;31(8):5689-5698. doi: 10.1007/s00330-021-07703-5. Epub 2021 Feb 18.

    PubMed 33599836

  • Shin HS, Na DG, Paik W, Yoon SJ, Gwon HY, Noh BJ, Kim WJ. Malignancy Risk Stratification of Thyroid Nodules with Macrocalcification and Rim Calcification Based on Ultrasound Patterns. Korean J Radiol. 2021 Apr;22(4):663-671. doi: 10.3348/kjr.2020.0381. Epub 2021 Feb 2.

    PubMed 33660454

  • Madeo B, Brigante G, Ansaloni A, Taliani E, Kaleci S, Monzani ML, Simoni M, Rochira V. The Added Value of Operator's Judgement in Thyroid Nodule Ultrasound Classification Arising From Histologically Based Comparison of Different Risk Stratification Systems. Front Endocrinol (Lausanne). 2020 Jul 7;11:434. doi: 10.3389/fendo.2020.00434. eCollection 2020.

    PubMed 32733383

  • Cozzolino A, Pozza C, Pofi R, Sbardella E, Faggiano A, Isidori AM, Giannetta E, Pernazza A, Rullo E, Ascoli V, Lenzi A, Gianfrilli D. Predictors of malignancy in high-risk indeterminate (TIR3B) cytopathology thyroid nodules. J Endocrinol Invest. 2020 Aug;43(8):1115-1123. doi: 10.1007/s40618-020-01200-0. Epub 2020 Feb 25.

    PubMed 32100197

  • Maia FF, Matos PS, Pavin EJ, Zantut-Wittmann DE. Thyroid imaging reporting and data system score combined with Bethesda system for malignancy risk stratification in thyroid nodules with indeterminate results on cytology. Clin Endocrinol (Oxf). 2015 Mar;82(3):439-44. doi: 10.1111/cen.12525. Epub 2014 Jul 7.

    PubMed 24930423

  • Remonti LR, Kramer CK, Leitao CB, Pinto LC, Gross JL. Thyroid ultrasound features and risk of carcinoma: a systematic review and meta-analysis of observational studies. Thyroid. 2015 May;25(5):538-50. doi: 10.1089/thy.2014.0353. Epub 2015 Mar 31.

    PubMed 25747526

  • Chaigneau E, Russ G, Royer B, Bigorgne C, Bienvenu-Perrard M, Rouxel A, Leenhardt L, Belin L, Buffet C. TIRADS score is of limited clinical value for risk stratification of indeterminate cytological results. Eur J Endocrinol. 2018 Jul;179(1):13-20. doi: 10.1530/EJE-18-0078. Epub 2018 Apr 27.

    PubMed 29703794

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Nodule and Thyroid Cancer, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).

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 3 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 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Age (time frame: Before Surgery). The study lists 11 primary outcomes in all. 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 NCT04904159, which also lists 9 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 1 Jun 2021.

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