NCT05604963Recruiting
Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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): * 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 456 (estimated)
- First submitted
- 22 Jul 2022
- Start date
- 14 Feb 2022
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- University College, London
- Diseases
- Thyroid cancer, Childhood cancers
- NCT number
- NCT05604963
What you commit to
- Study type: Interventional
- Planned participants: 456
- From 14 Feb 2022 to the primary completion date, 31 Jul 2028
- 33 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other
- \>4cm
- 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
- M1
Who the study is looking for
- Aged 16 or over
- 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)
Criteria the registry did not label
- Group 1 (HT already performed prior to diagnosis)
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (33)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal United Hospital Coordinator of this site? Confirm its status | Bath | United Kingdom | Not yet recruiting |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| University Hospitals Bristol and Weston NHS Foundation Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| University Hospital of Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Recruiting |
| Colchester Hospital Coordinator of this site? Confirm its status | Colchester | United Kingdom | Recruiting |
| Leighton Hospital Coordinator of this site? Confirm its status | Crewe | United Kingdom | Recruiting |
| Royal Derby Hospital Coordinator of this site? Confirm its status | Derby | United Kingdom | Recruiting |
| Ninewells Hospital Coordinator of this site? Confirm its status | Dundee | United Kingdom | Recruiting |
| NHS Lothian Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Recruiting |
| Royal Devon and Exeter Hospital Coordinator of this site? Confirm its status | Exeter | United Kingdom | Recruiting |
| Forth Valley Royal Hospital Coordinator of this site? Confirm its status | Falkirk | United Kingdom | Recruiting |
| Medway Maritime Hospital Coordinator of this site? Confirm its status | Gillingham | United Kingdom | Recruiting |
| NHS Greater Glasgow & Clyde Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| Ipswich Hospital Coordinator of this site? Confirm its status | Ipswich | United Kingdom | Recruiting |
| Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
| Liverpool University Hospitals Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| St. George's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Northwick Park Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Lister Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Guy's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Royal Marsden Hospitals Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Luton and Dunstable University Hospital Coordinator of this site? Confirm its status | Luton | United Kingdom | Recruiting |
| Northampton General Hospital Coordinator of this site? Confirm its status | Northampton | United Kingdom | Recruiting |
| Norfolk and Norwich University Hospital Coordinator of this site? Confirm its status | Norwich | United Kingdom | Recruiting |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Not yet recruiting |
| Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Recruiting |
| University Hospitals Dorset NHS Foundation Trust Coordinator of this site? Confirm its status | Poole | United Kingdom | Recruiting |
| Queen Alexandra Hospital Coordinator of this site? Confirm its status | Portsmouth | United Kingdom | Recruiting |
| Glan Clwyd Hospital (Betsi Cadwaladr University Health Board) Coordinator of this site? Confirm its status | Rhyl | United Kingdom | Recruiting |
| Sheffield Teaching Hospitals Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Musgrove Park Hospital Coordinator of this site? Confirm its status | Taunton | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.