Actively Recruiting
Hemithyroidectomy or Total Thyroidectomy in Low Risk Differentiated Thyroid Cancer Patients
Led by University College, London · Updated on 2026-03-05
456
Participants Needed
33
Research Sites
156 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
Researchers are evaluating surgical options for patients with low risk differentiated thyroid cancer. This phase III study aims to determine if hemithyroidectomy, which removes part of the thyroid gland, is an acceptable and cost-effective alternative to total thyroidectomy, which removes the entire gland. The trial includes two groups of patients based on their prior surgery status and diagnosis method, focusing on recurrence risk and prognosis. Participants are randomly assigned to different surgical treatments depending on their group. Group 1 patients who have had prior thyroid surgery will either have a second operation to remove the remaining thyroid tissue or undergo surveillance without further surgery. Group 2 patients who have not had surgery will be randomized to receive either hemithyroidectomy or total thyroidectomy in a single operation. The trial plans to recruit 456 participants and follow them regularly for six years after surgery. During the study, patients will attend follow-up visits post-surgery and then annually for six years. Researchers will monitor cancer recurrence rates at three and five years, assess the site and risk of recurrence, and record additional investigations and procedures after surgery. They will also evaluate surgical complications, voice function, hormone replacement needs, quality of life, and healthcare resource use at multiple time points. This comprehensive monitoring aims to compare outcomes between the different surgical approaches and understand their impact on patients' health and well-being over time.
CONDITIONS
Brief Title
Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 16 years or older
- Diagnosed with low risk differentiated thyroid cancer confirmed by biopsy or cytology
- For Group 1: Prior hemithyroidectomy performed before diagnosis
- For Group 1: Papillary thyroid cancer pT1b-2 (≤4 cm) with no or limited lymph node spread and confined to thyroid or minimal extension
- For Group 1: Follicular thyroid cancer pT1b-2 (≤4 cm) confined to thyroid or minimal extension
- For Group 2: No prior thyroid surgery
- For Group 2: Low risk differentiated thyroid cancer with cT1b-2, cN0, and no suspicious nodules in opposite thyroid lobe (U2 or U3/U4 with benign cytology)
You will not qualify if you...
- Tumors larger than 4 cm
- Unifocal papillary or follicular thyroid cancer ≤1 cm without limited lymph node involvement
- Non-invasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP)
- Anaplastic, poorly differentiated, or medullary thyroid carcinoma
- Gross extrathyroidal extension or pT4 stage
- More extensive lymph node involvement or spread (pN1b, >5 foci, extranodal spread)
- Distant metastases (M1)
- Aggressive papillary thyroid cancer variants (widely invasive, poorly differentiated, tall cell, columnar cell, hobnail, diffuse sclerosing)
- Follicular thyroid cancer with extensive vascular invasion or aggressive features
- Patients with incomplete tumor removal (R2) or macroscopic tumor invasion of local tissues or structures
- For Group 2: Presence of distant metastases (M1)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgery with recovery period until discharge
Participants undergo either hemithyroidectomy or total thyroidectomy surgery to remove part or all of the thyroid gland, followed by immediate post-operative care.
1 surgery visit and several visits until discharge
Duration - Up to 78 months from surgery date
Participants attend follow-up visits to monitor recovery, voice function, hormone replacement needs, quality of life, and check for cancer recurrence.
Multiple visits at 2-4 weeks and 6, 18, 30, 42, 54, 66, and 78 months after surgery
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here