Actively Recruiting
Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
Led by University College, London · Updated on 2026-03-05
456
Participants Needed
33
Research Sites
493 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
N
National Institute for Health Research, United Kingdom
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 16 or over
- For Group 1: Papillary thyroid cancer pT1b-2 (up to 4cm) with R0 resection or microscopic R1 resection
- For Group 1: cN0 or pN0, pNX, or pN1a (up to 5 foci, no extranodal spread)
- For Group 1: Tumour confined to thyroid or minimal extrathyroidal extension
- For Group 1: No higher risk histological variants on morphology (small foci allowed)
- For Group 1: No angioinvasion involving larger vascular structures
- For Group 1: Encapsulated follicular variant papillary thyroid carcinoma with capsular invasion only
- For Group 1: Micro-papillary thyroid carcinoma (≤1cm), multifocal or unifocal with limited pN1a
- For Group 1: Follicular thyroid cancer pT1b-2 (up to 4cm), minimally invasive with capsular invasion +/- minimal vascular invasion
- For Group 1: Tumour confined to thyroid or minimal extrathyroidal extension
- For Group 2: Low risk differentiated thyroid cancer confirmed by cytology or core biopsy
- For Group 2: cT1b-2 irrespective of molecular genetic markers
- For Group 2: cN0
- For Group 2: Contralateral lobe without suspicious nodules
You will not qualify if you...
- Tumours larger than 4cm
- Unifocal papillary or follicular thyroid cancer ≤1cm unless limited pN1a
- Non-invasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP)
- Anaplastic, poorly differentiated, or medullary thyroid carcinoma
- R2 resection
- Gross extrathyroidal extension
- pT4 or macroscopic tumour invasion of regional tissues
- pN1a with more than 5 foci or extranodal spread
- pN1b
- Presence of distant metastases (M1)
- Aggressive papillary thyroid cancer variants including widely invasive, poorly differentiated, anaplastic, or other high-risk variants
- Follicular thyroid cancer with extensive vascular invasion or widely invasive, poorly differentiated, or anaplastic features
AI-Screening
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Trial Site Locations
Total: 33 locations
1
Leighton Hospital
Crewe, Cheshire, United Kingdom, CW1 4QJ
Actively Recruiting
2
Royal United Hospital
Bath, United Kingdom
Not Yet Recruiting
3
Queen Elizabeth Hospital
Birmingham, United Kingdom
Actively Recruiting
4
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom
Actively Recruiting
5
Addenbrooke's Hospital
Cambridge, United Kingdom
Actively Recruiting
6
University Hospital of Wales
Cardiff, United Kingdom
Actively Recruiting
7
Colchester Hospital
Colchester, United Kingdom
Actively Recruiting
8
Royal Derby Hospital
Derby, United Kingdom
Actively Recruiting
9
Ninewells Hospital
Dundee, United Kingdom
Actively Recruiting
10
NHS Lothian
Edinburgh, United Kingdom
Actively Recruiting
11
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Actively Recruiting
12
Forth Valley Royal Hospital
Falkirk, United Kingdom
Actively Recruiting
13
Medway Maritime Hospital
Gillingham, United Kingdom
Actively Recruiting
14
NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
Actively Recruiting
15
Ipswich Hospital
Ipswich, United Kingdom
Actively Recruiting
16
Leicester Royal Infirmary
Leicester, United Kingdom
Actively Recruiting
17
Liverpool University Hospitals
Liverpool, United Kingdom
Actively Recruiting
18
Guy's Hospital
London, United Kingdom
Actively Recruiting
19
Lister Hospital
London, United Kingdom
Actively Recruiting
20
Northwick Park Hospital
London, United Kingdom
Actively Recruiting
21
St George's Hospital
London, United Kingdom
Actively Recruiting
22
The Royal Marsden Hospitals
London, United Kingdom
Actively Recruiting
23
University College London Hospital
London, United Kingdom
Not Yet Recruiting
24
Luton and Dunstable University Hospital
Luton, United Kingdom
Actively Recruiting
25
Northampton General Hospital
Northampton, United Kingdom
Actively Recruiting
26
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Actively Recruiting
27
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Not Yet Recruiting
28
Derriford Hospital
Plymouth, United Kingdom
Actively Recruiting
29
University Hospitals Dorset NHS Foundation Trust
Poole, United Kingdom
Actively Recruiting
30
Queen Alexandra Hospital
Portsmouth, United Kingdom
Actively Recruiting
31
Glan Clwyd Hospital (Betsi Cadwaladr University Health Board)
Rhyl, United Kingdom
Actively Recruiting
32
Sheffield Teaching Hospitals
Sheffield, United Kingdom
Actively Recruiting
33
Musgrove Park Hospital
Taunton, United Kingdom
Actively Recruiting
Research Team
J
Jeannie Chamberlain
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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