Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers (HoT)
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ClinicalTrials.gov Identifier: NCT05604963 |
Recruitment Status :
Recruiting
First Posted : November 3, 2022
Last Update Posted : November 29, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | July 22, 2022 | ||||
First Posted Date ICMJE | November 3, 2022 | ||||
Last Update Posted Date | November 29, 2023 | ||||
Actual Study Start Date ICMJE | February 14, 2022 | ||||
Estimated Primary Completion Date | July 31, 2028 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
3 Year Recurrence Rate [ Time Frame: From surgery to any signs or symptoms of the cancer or death assessed up to a maximum of 3 years from surgery date ] (defined as thyroid cancer recurrence, metastatic disease or death from thyroid cancer (whichever occurs first))
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers | ||||
Official Title ICMJE | Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers | ||||
Brief Summary | This is a multi-centre, randomised, non-inferiority, phase III study in patients with low risk differentiated thyroid cancer. Patients will be identified via oncology multidisciplinary team meetings. There will be two sources of patients in the trial, with the same histological diagnoses and prognosis (i.e. recurrence risk):
The overall aim of the trial is to determine whether hemithyroidectomy is an acceptable and cost-effective surgical procedure compared to total thyroidectomy in low risk thyroid cancer. Overall, 456 patients will be recruited to the trial. Patients will be initially be followed up post-surgery then 12 monthly for 6 years. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Differentiated Thyroid Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
456 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 31, 2031 | ||||
Estimated Primary Completion Date | July 31, 2028 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Group 1 (HT already performed prior to diagnosis) Inclusion criteria • Aged 16 or over Papillary thyroid cancer:
Follicular thyroid cancer (FTC), including oncocytic or Hürthle cell carcinoma:
Exclusion criteria
Group 2 (DTC on cytology or after core biopsy, who has not had prior thyroid surgery yet) Inclusion criteria
Exclusion criteria • M1 |
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05604963 | ||||
Other Study ID Numbers ICMJE | UCL/136591 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | University College, London | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University College, London | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | National Institute for Health Research, United Kingdom | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | University College, London | ||||
Verification Date | November 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |