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Thyroid CarcinomaTHYCOVIDNCT05178186

Impact of the COVID-19 Pandemic on Surgery for Thyroid Cancer

A study testing Thyroidectomy in people with Thyroid Carcinoma, run by University of Cagliari at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The impact of the COVID-19 pandemic has heavily influenced routine medical care. In the first months of the pandemic, healthcare authorities restricted medical care to emergency procedures, postponing elective surgical activity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Carcinoma
What is being tested?
Thyroidectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22,974 participants
Where
1 siteItaly
Study dates
20 Jun 2022to 15 Sep 2022
Phase
Interventional
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

Who may be able to join

  • Patients who have undergone thyroidectomy with preoperative diagnosis of thyroid cancer (cytological diagnosis, including Bethesda III, IV, IV or VI class, or high suspicion of thyroid carcinoma based on clinical and/or ultrasonographic features) during the study period (from February 2019 to October 2021)
  • Patients who underwent reoperative neck surgery for local recurrence of thyroid carcinoma during the study period (from February 2019 to October 2021)

Who cannot join

  • Age < 18 yo
  • Incidental diagnosis of thyroid carcinoma

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • AOU Cagliari

    Cagliari, CA, 09100

Other trials in Italy

About this study

Official title: Impact of the COVID-19 Pandemic on Surgery for Thyroid Cancer: an International Multicenter Study

The impact of the COVID-19 pandemic has heavily influenced routine medical care. In the first months of the pandemic, healthcare authorities restricted medical care to emergency procedures, postponing elective surgical activity. Conversely, screening programmes and planned examinations have been temporarily suspended or delayed. Gradually, elective surgery and clinical activities have resumed, thanks to the weakening of the pandemic, to a better organization of the healthcare systems and to the diffusion of COVID-19 vaccines.

In the present study, we aim to evaluate the impact of the COVID-19 pandemic on surgery for thyroid carcinoma. Particularly, we aim to investigate whether the delay in operations, screening programmes, and planned examinations for patients under follow-up after thyroid surgery have led to an increased number of aggressive tumours.

To evaluate this aspect, we aim to compare the patients who had undergone thyroidectomy for thyroid cancer before the COVID-19 pandemic (from February 2019 to February 2020), during the first phase of the pandemic (from March 2020 to September 2020), and after the first phase of the COVID-19 pandemic (from October 2020 to October 2021).

Being tested
Thyroidectomy
Medical subject headings
Thyroid Neoplasms

What participants receive

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

  • ThyroidectomyProcedure or surgery

    Surgery for thyroid carcinoma

Study groups in NCT05178186
Study groupRoleWhat they receive
Thyroid carcinomaOtherPatients with thyroid carcinoma submitted to thyroidectomy
Receives: Procedure: Thyroidectomy

What is being measured

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

  1. Incidence of aggressive thyroid cancers

    Increase in the number of patients with aggressive thyroid carcinoma (intermediate and high risk of local recurrence, according to 2015 American Thyroid Association Guidelines on Thyroid Carcinoma), calculated as ratio between patients with aggressive thyroid carcinoma operated in pre-pandemic period and patients with aggressive thyroid carcinoma operated during covid-19 pandemic.

    Measured: 36 months

Timeline

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

  1. First posted5 Jan 2022
  2. Study start20 Jun 2022
  3. Primary completion31 Jul 2022
  4. Study completion15 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22,974 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05178186
Sponsor's protocol ID
THYCOVID
Acronym
THYCOVID
Status last verified
Dec 2022
First submitted
30 Dec 2021
Last updated
15 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Medas F, Dobrinja C, Al-Suhaimi EA, Altmeier J, Anajar S, Arikan AE, Azaryan I, Bains L, Basili G, Bolukbasi H, Bononi M, Borumandi F, Bozan MB, Brenta G, Brunaud L, Brunner M, Buemi A, Canu GL, Cappellacci F, Cartwright SB, Castells Fuste I, Cavalheiro B, Cavallaro G, Chala A, Chan SYB, Chaplin J, Cheema MS, Chiapponi C, Chiofalo MG, Chrysos E, D'Amore A, de Cillia M, De Crea C, de Manzini N, de Matos LL, De Pasquale L, Del Rio P, Demarchi MS, Dhiwakar M, Donatini G, Dora JM, D'Orazi V, Doulatram Gamgaram VK, Eismontas V, Kabiri EH, El Malki HO, Elzahaby I, Enciu O, Eskander A, Feroci F, Figueroa-Bohorquez D, Filis D, Francois G, Frias-Fernandez P, Gamboa-Dominguez A, Genc V, Giordano D, Gomez-Pedraza A, Graceffa G, Griffin J, Guerreiro SC, Gupta K, Gupta KK, Gurrado A, Hajiioannou J, Hakala T, Harahap WA, Hargitai L, Hartl D, Hellmann A, Hlozek J, Hoang VT, Iacobone M, Innaro N, Ioannidis O, Jang JHI, Xavier-Junior JC, Jovanovic M, Kaderli RM, Kakamad F, Kaliszewski K, Karamanliev M, Katoh H, Kosec A, Kovacevic B, Kowalski LP, Kralik R, Yadav SK, Kumorova A, Lampridis S, Lasithiotakis K, Leclere JC, Leong EKF, Leow MK, Lim JY, Lino-Silva LS, Liu SYW, Llorach NP, Lombardi CP, Lopez-Gomez J, Lori E, Quintanilla-Dieck L, Lucchini R, Madani A, Manatakis D, Markovic I, Materazzi G, Mazeh H, Mercante G, Meyer-Rochow GY, Mihaljevic O, Miller JA, Minuto M, Monacelli M, Mulita F, Mullineris B, Munoz-de-Nova JL, Muradas Girardi F, Nader S, Napadon T, Nastos C, Offi C, Ronen O, Oragano L, Orois A, Pan Y, Panagiotidis E, Panchangam RB, Papavramidis T, Parida PK, Paspala A, Perez OV, Petrovic S, Raffaelli M, Ramacciotti CF, Ratia Gimenez T, Rivo Vazquez A, Roh JL, Rossi L, Sanabria A, Santeerapharp A, Semenov A, Seneviratne S, Serdar A, Sheahan P, Sheppard SC, Slotcavage RL, Smaxwil C, Kim SY, Sorrenti S, Spartalis E, Sriphrapradang C, Testini M, Turk Y, Tzikos G, Vabalayte K, Vargas-Osorio K, Vazquez Renteria RS, Velazquez-Fernandez D, Vithana SMP, Yucel L, Yulian ED, Zahradnikova P, Zarogoulidis P, Ziablitskaia E, Zolotoukho A, Calo PG; THYCOVID Collaboration Group. Effect of the COVID-19 pandemic on surgery for indeterminate thyroid nodules (THYCOVID): a retrospective, international, multicentre, cross-sectional study. Lancet Diabetes Endocrinol. 2023 Jun;11(6):402-413. doi: 10.1016/S2213-8587(23)00094-3. Epub 2023 Apr 28.

    PubMed 37127041

Questions about this trial

What is this clinical trial studying?

A study testing Thyroidectomy in people with Thyroid Carcinoma, run by University of Cagliari at 1 site in Italy.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 15 Dec 2022. 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 Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of aggressive thyroid cancers (time frame: 36 months). 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 NCT05178186, which also lists 1 linked publication.

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 15 Dec 2022.

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