Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
NCT ID: NCT05604963
Last Updated: 2025-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
456 participants
INTERVENTIONAL
2022-02-14
2031-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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):
* Group 1: Patients who have already had a HT for thyroid problems and are then subsequently diagnosed with low risk DTC will be randomised 1:1 to undergo surveillance only OR a second operation to remove the rest of their thyroid gland (two-stage total thyroidectomy).
* Group 2: Patients diagnosed with low risk DTC using cytology (Thy5) but no surgery performed will be randomised 1:1 to have either a hemi-thyroidectomy OR a single-stage total thyroidectomy.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Radiofrequency Ablation Versus Hemithyroidectomy of Small Thyroid Cancers
NCT06796348
ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer
NCT03570021
The Safety and Feasibility of Radiofrequency Ablation to Treat Low-risk Thyroid Cancer
NCT06929650
A Prospective, Open-label, Multicenter, Randomized Controlled Phase III Study of Prophylactic Central Neck Dissection in Low-risk Papillary Thyroid Cancer
NCT06082180
Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in People With Low-risk Papillary Thyroid Cancer
NCT02408887
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: Two-stage Completion Thyroidectomy
Patients randomised to this arm will undergo a 2nd operation to remove the remaining thyroid lobe.
Total Thyroidectomy
Total Thyroidectomy - surgical removal of entire thyroid gland
Group 1: Surveillance
Patients randomised to this arm will have no 2nd surgery and proceed directly to follow-up visits.
No interventions assigned to this group
Group 2: Hemi-thyroidectomy
Patients randomised to this arm will have a single HT operation to remove thyroid lobe with the tumour.
Hemithyroidectomy
Hemithyroidectomy - surgical removal of partial thyroid gland
Group 2: Total Thyroidectomy
Patients randomised to this arm will have a single TT operation to remove the entire thyroid gland.
Total Thyroidectomy
Total Thyroidectomy - surgical removal of entire thyroid gland
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Total Thyroidectomy
Total Thyroidectomy - surgical removal of entire thyroid gland
Hemithyroidectomy
Hemithyroidectomy - surgical removal of partial thyroid gland
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Papillary thyroid cancer:
* pT1b-2 (≤4cm) irrespective of molecular genetic markers
* R0 resection (clinically excised but microscopic R1 resected tumours at discretion of the local MDT)
* cN0 or pN0, pNX \& pN1a (≤5 foci, no extranodal spread)
* Confined to thyroid or minimal extrathyroidal extension
* No higher risk histological variants on morphology (small foci allowed at the discretion of the local MDT)
* No angioinvasion NB. PTC is still eligible where microscopic invasion of endothelial lined small capillary vascular spaces and lymphatic channels are present. It becomes ineligible in the rare instances when there is definite invasion of a larger vascular structure such as a vein with smooth muscle in its wall.
* Encapsulated FVPTC with capsular invasion only
* Micro-PTC (≤1cm)
* multifocal
* unifocal with pN1a (≤5 foci; no extranodal spread)
Follicular thyroid cancer (FTC), including oncocytic or Hürthle cell carcinoma:
* pT1b-2 (≤4cm) irrespective of molecular genetic markers
\- Minimally invasive, with capsular invasion +/- minimal (≤4 foci) vascular invasion (the latter is now called encapsulated angioinvasive and is at the discretion of the MDT)
* Confined to thyroid or minimal extrathyroidal extension
* Aged 16 or over
* 'low risk' differentiated thyroid cancer confirmed by cytology or core biopsy.
* cT1b-2 irrespective of molecular genetic markers
* cN0
* Contralateral lobe without suspicious nodule(s) (U2, or U3/U4 with Thy2 on FNAC)
Exclusion Criteria
* unifocal pT1a (≤1cm) PTC or FTC (unless pN1a as above)
* NIFTP (non-invasive follicular thyroid neoplasm with papillary-like nuclear features)
* Anaplastic, poorly differentiated or medullary thyroid carcinoma
* R2
* gross extrathyroidal extension
* pT4 or macroscopic tumour invasion of loco-regional tissues or structures
* pN1a with \>5 foci or extranodal spread
* pN1b
* M1
* Aggressive PTC with any of the following features:
* Widely invasive
* Poorly differentiated
* Anaplastic
* predominance of Tall cell, Columnar cell, Hobnail, Diffuse sclerosing and other higher risk variants
* FTC, including oncocytic or Hürthle cell cancer with any of the following features:
* Minimally invasive with extensive vascular invasion (now called encapsulated angioinvasive) (\>4 foci)
* Widely invasive
* Poorly differentiated
* Anaplastic
Group 2 (DTC on cytology or after core biopsy, who has not had prior thyroid surgery yet)
• M1
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute for Health Research, United Kingdom
OTHER_GOV
University College, London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Leighton Hospital
Crewe, Cheshire, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Royal United Hospital
Bath, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Colchester Hospital
Colchester, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
NHS Lothian
Edinburgh, , United Kingdom
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Forth Valley Royal Hospital
Falkirk, , United Kingdom
Medway Maritime Hospital
Gillingham, , United Kingdom
NHS Greater Glasgow & Clyde
Glasgow, , United Kingdom
Ipswich Hospital
Ipswich, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Liverpool University Hospitals
Liverpool, , United Kingdom
Guy's Hospital
London, , United Kingdom
Lister Hospital
London, , United Kingdom
Northwick Park Hospital
London, , United Kingdom
St George's Hospital
London, , United Kingdom
The Royal Marsden Hospitals
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Luton and Dunstable University Hospital
Luton, , United Kingdom
Northampton General Hospital
Northampton, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
University Hospitals Dorset NHS Foundation Trust
Poole, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Glan Clwyd Hospital (Betsi Cadwaladr University Health Board)
Rhyl, , United Kingdom
Sheffield Teaching Hospitals
Sheffield, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UCL/136591
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.