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New treatment option for Differentiated Thyroid Cancer
Official title Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
ClinicalTrials.gov ID: NCT05604963
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Group 1 (HT already performed prior to diagnosis)
- 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)
You likely can't join if
- \>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
- gross extrathyroidal extension
- pT4 or macroscopic tumour invasion of loco-regional tissues or structures
See the full eligibility criteria
- Group 1 (HT already performed prior to diagnosis)
- 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...
- 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...
- Confined to thyroid or minimal extrathyroidal extension
- \>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
- gross extrathyroidal extension
- pT4 or macroscopic tumour invasion of loco-regional tissues or structures
- pN1a with \>5 foci or extranodal spread
- pN1b
- 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
- Contralateral lobe without suspicious nodule(s) (U2, or U3/U4 with Thy2 on FNAC) Exclusion criteria
The study team makes the final eligibility decision.
Where it's taking place
- Crewe, Cheshire, United Kingdom
- Bath, United Kingdom
- Birmingham, United Kingdom
- Bristol, United Kingdom
- Cambridge, United Kingdom
- Cardiff, United Kingdom
- Colchester, United Kingdom
- Derby, United Kingdom
- Dundee, United Kingdom
- Edinburgh, United Kingdom
- Exeter, United Kingdom
- Falkirk, United Kingdom
- Gillingham, United Kingdom
- Glasgow, United Kingdom
- Ipswich, United Kingdom
- Leicester, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
- Luton, United Kingdom
- Northampton, United Kingdom
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Crewe, Cheshire, United Kingdom; Bath, United Kingdom; Birmingham, United Kingdom; Bristol, United Kingdom; Cambridge, United Kingdom; Cardiff, United Kingdom and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.