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Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers

Sponsor: University College, London

NCT ID: NCT05604963

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Total Thyroidectomy (procedure), Hemithyroidectomy (procedure)
How long the study runs
Study runs about 113 months (dates as stated)
About the drug or intervention
Total Thyroidectomy — procedure: Total Thyroidectomy - surgical removal of entire thyroid gland · Hemithyroidectomy — procedure: Hemithyroidectomy - surgical removal of partial thyroid gland
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
16 Years and over
Who
All
Number of participants
456
Started
2022-02-14
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for differentiated thyroid cancer
  • • NA - 456 participants
  • • This is a multi-centre, randomised, non-inferiority, phase III study in patients with low risk differentiated thyroid cancer

Who can take part?

  • • Ages 16 Years and over
  • • Diagnosed with differentiated thyroid cancer

Where?

  • • Crewe - Leighton Hospital
  • • Bath - Royal United Hospital
  • • Birmingham - Queen Elizabeth Hospital
  • • Bristol - University Hospitals Bristol and Weston NHS Foundation Trust
  • • +29 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Differentiated Thyroid Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Group 1 (HT already performed prior to diagnosis)
  • ✓Inclusion criteria
  • ✓Aged 16 or over
  • ✓Papillary thyroid cancer:
  • ✓pT1b-2 (≤4cm) irrespective of molecular genetic markers
See the full criteria
Group 1 (HT already performed prior to diagnosis) Inclusion criteria • 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 Exclusion criteria * \>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 * 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) Inclusion criteria * 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) Exclusion criteria • M1

Where Is This Study? (33 UK sites)

Leighton Hospital

Crewe CW1 4QJ, United Kingdom

Recruiting
Site contact (verified)
Eriola MushiPrincipal Investigator

Royal United Hospital

Bath, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Andrew CarswellPrincipal Investigator

Queen Elizabeth Hospital

Birmingham, United Kingdom

Recruiting
Site contact (verified)
Neil SharmaPrincipal Investigator

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, United Kingdom

Recruiting
Site contact (verified)
Oliver DalePrincipal Investigator

Addenbrooke's Hospital

Cambridge, United Kingdom

Recruiting
Site contact (verified)
Brian FishPrincipal Investigator

University Hospital of Wales

Cardiff, United Kingdom

Recruiting
Site contact (verified)
Michael StechmanPrincipal Investigator

Colchester Hospital

Colchester, United Kingdom

Recruiting
Site contact (verified)
Abdul QureshiPrincipal Investigator

Royal Derby Hospital

Derby, United Kingdom

Recruiting
Site contact (verified)
Hazem NijimPrincipal Investigator

Ninewells Hospital

Dundee, United Kingdom

Recruiting
Site contact (verified)
Jaiganesh ManickavasagamPrincipal Investigator

NHS Lothian

Edinburgh, United Kingdom

Recruiting
Site contact (verified)
Iain NixonPrincipal Investigator

Royal Devon and Exeter Hospital

Exeter, United Kingdom

Recruiting
Site contact (verified)
Joel SmithPrincipal Investigator

Forth Valley Royal Hospital

Falkirk, United Kingdom

Recruiting
Site contact (verified)
Michail WinklerPrincipal Investigator

Medway Maritime Hospital

Gillingham, United Kingdom

Recruiting
Site contact (verified)
Maria AcostaPrincipal Investigator

NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

Recruiting
Site contact (verified)
Catriona DouglasPrincipal Investigator

Ipswich Hospital

Ipswich, United Kingdom

Recruiting
Site contact (verified)
Billy WongPrincipal Investigator

Leicester Royal Infirmary

Leicester, United Kingdom

Recruiting
Site contact (verified)
Oladejo OlaleyePrincipal Investigator

Liverpool University Hospitals

Liverpool, United Kingdom

Recruiting
Site contact (verified)
Christopher LohPrincipal Investigator

Guy's Hospital

London, United Kingdom

Recruiting
Site contact (verified)
Ricard SimoPrincipal Investigator

Lister Hospital

London, United Kingdom

Recruiting
Site contact (verified)
George MochloulisPrincipal Investigator

Northwick Park Hospital

London, United Kingdom

Recruiting
Site contact (verified)
Zi Wei LiuPrincipal Investigator

St George's Hospital

London, United Kingdom

Recruiting
Site contact (verified)
Enyinnaya OfoPrincipal Investigator

The Royal Marsden Hospitals

London, United Kingdom

Recruiting
Site contact (verified)
Vinidh PaleriPrincipal Investigator

University College London Hospital

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Tarek Abdel-AzizPrincipal Investigator

Luton and Dunstable University Hospital

Luton, United Kingdom

Recruiting
Site contact (verified)
Tarun SoodPrincipal Investigator

Northampton General Hospital

Northampton, United Kingdom

Recruiting
Site contact (verified)
Rohan BidayePrincipal Investigator

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Recruiting
Site contact (verified)
Ramez NassifPrincipal Investigator

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Neeraj SethiPrincipal Investigator

Derriford Hospital

Plymouth, United Kingdom

Recruiting
Site contact (verified)
Richard WilliamsPrincipal Investigator

University Hospitals Dorset NHS Foundation Trust

Poole, United Kingdom

Recruiting
Site contact (verified)
Neil De ZoysaPrincipal Investigator

Queen Alexandra Hospital

Portsmouth, United Kingdom

Recruiting
Site contact (verified)
Costa RepanosPrincipal Investigator

Glan Clwyd Hospital (Betsi Cadwaladr University Health Board)

Rhyl, United Kingdom

Recruiting
Site contact (verified)
Kym BestPrincipal Investigator

Sheffield Teaching Hospitals

Sheffield, United Kingdom

Recruiting
Site contact (verified)
Saba BalasubramanianPrincipal Investigator

Musgrove Park Hospital

Taunton, United Kingdom

Recruiting
Site contact (verified)
Edward ChisholmPrincipal Investigator

How to Get in Touch

Jeannie Chamberlain

Sponsor contact

CONTACT

020 3108 4875 ctc.hot@ucl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-03