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

NCT05604963 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2026-03-05

No results posted yet for this study

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.

Conditions

  • Differentiated Thyroid Cancer

Interventions

PROCEDURE

Total Thyroidectomy

Total Thyroidectomy - surgical removal of entire thyroid gland

PROCEDURE

Hemithyroidectomy

Hemithyroidectomy - surgical removal of partial thyroid gland

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University College, London

    lead OTHER

Principal Investigators

  • Dae Kim · The Royal Marsden Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2028-07-31
Completion
2031-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05604963 on ClinicalTrials.gov