Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
ID05604963

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

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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

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