Back to resultsImpact of the COVID-19 Pandemic on Surgery for Thyroid Cancer (THYCOVID)
Primary Purpose
Thyroid Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Thyroidectomy
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Age < 18 yo
- Incidental diagnosis of thyroid carcinoma
Sites / Locations
- AOU Cagliari
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Thyroid carcinoma
Arm Description
Patients with thyroid carcinoma submitted to thyroidectomy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05178186
First Posted
December 30, 2021
Last Updated
December 14, 2022
Sponsor
University of Cagliari
1. Study Identification
Unique Protocol Identification Number
NCT05178186
Brief Title
Impact of the COVID-19 Pandemic on Surgery for Thyroid Cancer
Acronym
THYCOVID
Official Title
Impact of the COVID-19 Pandemic on Surgery for Thyroid Cancer: an International Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22974 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thyroid carcinoma
Arm Type
Other
Arm Description
Patients with thyroid carcinoma submitted to thyroidectomy
Intervention Type
Procedure
Intervention Name(s)
Thyroidectomy
Intervention Description
Surgery for thyroid carcinoma
Primary Outcome Measure Information:
Title
Incidence of aggressive thyroid cancers
Description
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.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Age < 18 yo
Incidental diagnosis of thyroid carcinoma
Facility Information:
Facility Name
AOU Cagliari
City
Cagliari
State/Province
CA
ZIP/Postal Code
09100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of the COVID-19 Pandemic on Surgery for Thyroid Cancer
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