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Differentiated Thyroid CancerHoTNCT05604963

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

A study testing Total Thyroidectomy and Hemithyroidectomy in people with Differentiated Thyroid Cancer, run by University College, London at 33 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Differentiated Thyroid Cancer
What is being tested?
Total Thyroidectomy and Hemithyroidectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
456 participants
Where
33 sitesUnited Kingdom
Study dates
14 Feb 2022to 31 Jul 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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)

Who cannot join

  • >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
Show all 22Show fewer
  • 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)
  • M1

Trial locations and contacts

33 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jeannie Chamberlain contact

020 3108 4875

ctc.hot@ucl.ac.uk

33 sites in 1 country

United Kingdom33 sites, 33 recruiting
  • Royal United Hospital

    Bath

    Andrew Carswell

    Not yet recruiting
  • Queen Elizabeth Hospital

    Birmingham

    Neil Sharma

    Recruiting
  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol

    Oliver Dale

    Recruiting
  • Addenbrooke's Hospital

    Cambridge

    Brian Fish

    Recruiting
  • University Hospital of Wales

    Cardiff

    Michael Stechman

    Recruiting
  • Colchester Hospital

    Colchester

    Abdul Qureshi

    Recruiting
  • Leighton Hospital

    Crewe, Cheshire, CW1 4QJ

    Eriola Mushi

    Recruiting
  • Royal Derby Hospital

    Derby

    Hazem Nijim

    Recruiting
  • Ninewells Hospital

    Dundee

    Jaiganesh Manickavasagam

    Recruiting
  • NHS Lothian

    Edinburgh

    Iain Nixon

    Recruiting
  • Royal Devon and Exeter Hospital

    Exeter

    Joel Smith

    Recruiting
  • Forth Valley Royal Hospital

    Falkirk

    Michail Winkler

    Recruiting
  • Medway Maritime Hospital

    Gillingham

    Maria Acosta

    Recruiting
  • NHS Greater Glasgow & Clyde

    Glasgow

    Catriona Douglas

    Recruiting
  • Ipswich Hospital

    Ipswich

    Billy Wong

    Recruiting
  • Leicester Royal Infirmary

    Leicester

    Oladejo Olaleye

    Recruiting
  • Liverpool University Hospitals

    Liverpool

    Christopher Loh

    Recruiting
  • Guy's Hospital

    London

    Ricard Simo

    Recruiting
  • Lister Hospital

    London

    George Mochloulis

    Recruiting
  • Northwick Park Hospital

    London

    Zi Wei Liu

    Recruiting
  • St George's Hospital

    London

    Enyinnaya Ofo

    Recruiting
  • The Royal Marsden Hospitals

    London

    Vinidh Paleri

    Recruiting
  • University College London Hospital

    London

    Tarek Abdel-Aziz

    Not yet recruiting
  • Luton and Dunstable University Hospital

    Luton

    Tarun Sood

    Recruiting
  • Northampton General Hospital

    Northampton

    Rohan Bidaye

    Recruiting
  • Norfolk and Norwich University Hospital

    Norwich

    Ramez Nassif

    Recruiting
  • Nottingham University Hospitals NHS Trust

    Nottingham

    Neeraj Sethi

    Not yet recruiting
  • Derriford Hospital

    Plymouth

    Richard Williams

    Recruiting
  • University Hospitals Dorset NHS Foundation Trust

    Poole

    Neil De Zoysa

    Recruiting
  • Queen Alexandra Hospital

    Portsmouth

    Costa Repanos

    Recruiting
  • Glan Clwyd Hospital (Betsi Cadwaladr University Health Board)

    Rhyl

    Kym Best

    Recruiting
  • Sheffield Teaching Hospitals

    Sheffield

    Saba Balasubramanian

    Recruiting
  • Musgrove Park Hospital

    Taunton

    Edward Chisholm

    Recruiting

Other trials in United Kingdom

About this study

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):

Read more
  • 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.

Being tested
Total Thyroidectomy, Hemithyroidectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total ThyroidectomyProcedure or surgery

    Total Thyroidectomy - surgical removal of entire thyroid gland

  • HemithyroidectomyProcedure or surgery

    Hemithyroidectomy - surgical removal of partial thyroid gland

Study groups in NCT05604963
Study groupRoleWhat they receive
Group 1: Two-stage Completion ThyroidectomyActive comparatorPatients randomised to this arm will undergo a 2nd operation to remove the remaining thyroid lobe.
Receives: Procedure: Total Thyroidectomy
Group 1: SurveillanceNo interventionPatients randomised to this arm will have no 2nd surgery and proceed directly to follow-up visits.
Group 2: Hemi-thyroidectomyExperimentalPatients randomised to this arm will have a single HT operation to remove thyroid lobe with the tumour.
Receives: Procedure: Hemithyroidectomy
Group 2: Total ThyroidectomyActive comparatorPatients randomised to this arm will have a single TT operation to remove the entire thyroid gland.
Receives: Procedure: Total Thyroidectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3 Year Recurrence Rate

    (defined as thyroid cancer recurrence, metastatic disease or death from thyroid cancer (whichever occurs first))

    Measured: From surgery to any signs or symptoms of the cancer or death assessed up to a maximum of 3 years from surgery date

Secondary outcomes (17)
  1. 5 Year Recurrence Rate

    (defined as thyroid cancer recurrence, metastatic disease or death from thyroid cancer (whichever occurs first))

    Measured: From surgery to any signs or symptoms of the cancer or death assessed up to a maximum of 5 years from surgery date

  2. Anatomical Site of Recurrence

    Location of recurrence

    Measured: From surgery to confirmed recurrence assessed up to a maximum of 5 years from surgery date

  3. Risk of Loco-Regional Recurrence

    (based on time to recurrence in the neck only)

    Measured: From surgery to confirmed recurrence assessed up to a maximum of 5 years from surgery date

  4. Number of Additional Investigations and Procedures after Surgery

    Number of further investigations/procedures related to the patient's thyroid surgery or thyroid cancer e.g. imaging, blood test, biopsy etc.

    Measured: 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery

  5. Type of Additional Investigations and Procedures after Surgery

    Type of further investigations/procedures related to the patient's thyroid surgery or thyroid cancer e.g. imaging, blood test, biopsy etc.

    Measured: 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery

  6. Voice Function

    Measured using the Voice Handicap Index questionnaire (VHI-10); scores range from 0-40 with higher scores indicating greater voice-related handicap

    Measured: Surgical complications and severity: From surgery date to discharge, 2-4 weeks, 6 months and 18 months from date of surgery; Voice Function: Post-randomisation/pre-surgery, 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.

  7. Surgical complications and severity

    Using CTCAE v5.0 and the highest grade of each event type for each patient

    Measured: Surgical complications and severity: From surgery date to discharge, 2-4 weeks, 6 months and 18 months from date of surgery; Voice Function: Post-randomisation/pre-surgery, 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.

  8. Requirement for Hormone Replacement Therapy

    (percentage of patients who require this therapy compared between the trial arms)

    Measured: From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.

  9. Health Related Quality of Life (EORTC QLQ-C30)

    Measured using EORTC QLQ-C30; Scales range from 0-100 with higher scores for the functioning scales and global health status indicating higher QoL and higher scores on the symptom and single-item scales indicating lower QoL

    Measured: Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.

  10. Health Related Quality of Life (EORTC QLQ-THY35)

    Measured using EORTC QLQ-THY35; Scales range from 0-100 with higher scores indicating higher QoL and lower scores indicating lower QoL

    Measured: Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.

  11. Health Related Quality of Life (EQ-5D-5L)

    Measured using EQ-5D-5L; EQVAS score ranges from 0-100 with higher scores indicating higher QoL and lower scores indicating lower QoL; EQ-5D-5L index scores range from -0.224-1 with higher scores indicating higher QoL and lower scores indicating lower QoL

    Measured: Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.

  12. Health Related Quality of Life (FoP-Q-SF)

    Measured using FoP-Q-SF; scores range from 12-60 with higher scores indicating lower QoL and lower scores indicating higher QoL

    Measured: Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.

  13. Cost and Health Resource Use (EQ-5D-5L)

    Measured using EQ-5D-5L (generic QoL)

    Measured: a. Baseline, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. b. From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. c/d. 6, 18, 30, 42, 54, 66 & 78 months from date of surgery

  14. Cost and Health Resource Use (EORTC QLQ-C30)

    Measured using EORTC QLQ-C30 (cancer-specific QoL)

    Measured: a. Baseline, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. b. From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. c/d. 6, 18, 30, 42, 54, 66 & 78 months from date of surgery

  15. Cost and Health Resource Use (EORTC QLQ-THY34)

    Measured using EORTC QLQ-THY34 (Cancer site specific QoL)

    Measured: a. Baseline, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. b. From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. c/d. 6, 18, 30, 42, 54, 66 & 78 months from date of surgery

  16. Secondary Care Health Resource Use

    Collected using eCRFs and retrospectively for the study period from data in the Hospital Episodes Statistics linked to records in the NCRAS

    Measured: a. Baseline, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. b. From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. c/d. 6, 18, 30, 42, 54, 66 & 78 months from date of surgery

  17. Primary Care Health Resource Use

    Collected using eCRFs (Review of Primary Care Visits)

    Measured: a. Baseline, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. b. From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. c/d. 6, 18, 30, 42, 54, 66 & 78 months from date of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2022
  2. Study start14 Feb 2022
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
456 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05604963
Sponsor's protocol ID
UCL/136591
Acronym
HoT
Status last verified
Mar 2026
First submitted
22 Jul 2022
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Total Thyroidectomy and Hemithyroidectomy in people with Differentiated Thyroid Cancer, run by University College, London at 33 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jeannie Chamberlain (020 3108 4875, ctc.hot@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3 Year Recurrence Rate (time frame: From surgery to any signs or symptoms of the cancer or death assessed up to a maximum of 3 years from surgery date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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