Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
NCT05604963

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

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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