RecruitingNot ApplicableNCT05604963

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


Sponsor

University College, London

Enrollment

456 participants

Start Date

Feb 14, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether removing only half the thyroid gland (instead of all of it) is safe and effective for people with certain low-risk thyroid cancers, such as papillary or follicular thyroid cancer that hasn't spread widely. **You may be eligible if...** - You are 16 years old or older - You have a low-risk papillary or follicular thyroid cancer (tumor 4 cm or smaller, not spread to distant sites) - Your cancer hasn't spread beyond the thyroid or has only minimal spread - You have already had half the thyroid removed, OR you have a suspected thyroid cancer that hasn't been surgically treated yet **You may NOT be eligible if...** - Your tumor is larger than 4 cm - Your cancer has spread to distant parts of the body (metastasis) - You have an aggressive thyroid cancer type (such as anaplastic, poorly differentiated, or medullary) - Your cancer has grown extensively beyond the thyroid - You have a non-cancerous condition called NIFTP Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETotal Thyroidectomy

Total Thyroidectomy - surgical removal of entire thyroid gland

PROCEDUREHemithyroidectomy

Hemithyroidectomy - surgical removal of partial thyroid gland


Locations(33)

Leighton Hospital

Crewe, Cheshire, United Kingdom

Royal United Hospital

Bath, United Kingdom

Queen Elizabeth Hospital

Birmingham, United Kingdom

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Colchester Hospital

Colchester, United Kingdom

Royal Derby Hospital

Derby, United Kingdom

Ninewells Hospital

Dundee, United Kingdom

NHS Lothian

Edinburgh, United Kingdom

Royal Devon and Exeter Hospital

Exeter, United Kingdom

Forth Valley Royal Hospital

Falkirk, United Kingdom

Medway Maritime Hospital

Gillingham, United Kingdom

NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

Ipswich Hospital

Ipswich, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom

Liverpool University Hospitals

Liverpool, United Kingdom

Guy's Hospital

London, United Kingdom

Lister Hospital

London, United Kingdom

Northwick Park Hospital

London, United Kingdom

St George's Hospital

London, United Kingdom

The Royal Marsden Hospitals

London, United Kingdom

University College London Hospital

London, United Kingdom

Luton and Dunstable University Hospital

Luton, United Kingdom

Northampton General Hospital

Northampton, United Kingdom

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

University Hospitals Dorset NHS Foundation Trust

Poole, United Kingdom

Queen Alexandra Hospital

Portsmouth, United Kingdom

Glan Clwyd Hospital (Betsi Cadwaladr University Health Board)

Rhyl, United Kingdom

Sheffield Teaching Hospitals

Sheffield, United Kingdom

Musgrove Park Hospital

Taunton, United Kingdom

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