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NCT05604963Recruiting

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

Source: ClinicalTrials.gov · Last updated 5 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
456 (estimated)
First submitted
22 Jul 2022
Start date
14 Feb 2022
Primary completion date
31 Jul 2028
Lead sponsor
University College, London
NCT number
NCT05604963

What you commit to

  • Study type: Interventional
  • Planned participants: 456
  • From 14 Feb 2022 to the primary completion date, 31 Jul 2028
  • 33 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other

  • \>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
  • M1

Who the study is looking for

  • 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
  • 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)

Criteria the registry did not label

  • Group 1 (HT already performed prior to diagnosis)

Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (33)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal United Hospital
Coordinator of this site? Confirm its status
BathUnited KingdomNot yet recruiting
Queen Elizabeth Hospital
Coordinator of this site? Confirm its status
BirminghamUnited KingdomRecruiting
University Hospitals Bristol and Weston NHS Foundation Trust
Coordinator of this site? Confirm its status
BristolUnited KingdomRecruiting
Addenbrooke's Hospital
Coordinator of this site? Confirm its status
CambridgeUnited KingdomRecruiting
University Hospital of Wales
Coordinator of this site? Confirm its status
CardiffUnited KingdomRecruiting
Colchester Hospital
Coordinator of this site? Confirm its status
ColchesterUnited KingdomRecruiting
Leighton Hospital
Coordinator of this site? Confirm its status
CreweUnited KingdomRecruiting
Royal Derby Hospital
Coordinator of this site? Confirm its status
DerbyUnited KingdomRecruiting
Ninewells Hospital
Coordinator of this site? Confirm its status
DundeeUnited KingdomRecruiting
NHS Lothian
Coordinator of this site? Confirm its status
EdinburghUnited KingdomRecruiting
Royal Devon and Exeter Hospital
Coordinator of this site? Confirm its status
ExeterUnited KingdomRecruiting
Forth Valley Royal Hospital
Coordinator of this site? Confirm its status
FalkirkUnited KingdomRecruiting
Medway Maritime Hospital
Coordinator of this site? Confirm its status
GillinghamUnited KingdomRecruiting
NHS Greater Glasgow & Clyde
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GlasgowUnited KingdomRecruiting
Ipswich Hospital
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IpswichUnited KingdomRecruiting
Leicester Royal Infirmary
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LeicesterUnited KingdomRecruiting
Liverpool University Hospitals
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LiverpoolUnited KingdomRecruiting
University College London Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomNot yet recruiting
St. George's Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Northwick Park Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Lister Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Guy's Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
The Royal Marsden Hospitals
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Luton and Dunstable University Hospital
Coordinator of this site? Confirm its status
LutonUnited KingdomRecruiting
Northampton General Hospital
Coordinator of this site? Confirm its status
NorthamptonUnited KingdomRecruiting
Norfolk and Norwich University Hospital
Coordinator of this site? Confirm its status
NorwichUnited KingdomRecruiting
Nottingham University Hospitals NHS Trust
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NottinghamUnited KingdomNot yet recruiting
Derriford Hospital
Coordinator of this site? Confirm its status
PlymouthUnited KingdomRecruiting
University Hospitals Dorset NHS Foundation Trust
Coordinator of this site? Confirm its status
PooleUnited KingdomRecruiting
Queen Alexandra Hospital
Coordinator of this site? Confirm its status
PortsmouthUnited KingdomRecruiting
Glan Clwyd Hospital (Betsi Cadwaladr University Health Board)
Coordinator of this site? Confirm its status
RhylUnited KingdomRecruiting
Sheffield Teaching Hospitals
Coordinator of this site? Confirm its status
SheffieldUnited KingdomRecruiting
Musgrove Park Hospital
Coordinator of this site? Confirm its status
TauntonUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.