ISRCTN17004671进行中（未招募）未知
Hemithyroidectomy or Total Thyroidectomy in 'low-risk' thyroid cancers
niversity College London0 个研究点目标入组 456 人开始时间: 2022年2月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 456
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Group 1 (Hemithyroidectomy already performed prior to diagnosis)
- •1. Aged 16 or over
- •2. Papillary thyroid cancer (PTC):
- •2.1. pT1b-2 (=4cm) irrespective of molecular genetic markers
- •2.2. R0 resection (clinically excised but microscopic R1 resected tumours at discretion of the local multidisciplinary team (MDT))
- •2.3. cN0 or pN0, pNX & pN1a (=5 foci, no extranodal spread)
- •2.4. Confined to thyroid or minimal extrathyroidal extension
- •2.5. No higher risk histological variants on morphology (small foci allowed at the discretion of the local MDT)
- •2.6. No angioinvasion
- •2.7. Encapsulated follicular variant of PTC with capsular invasion only
- •2.8. Micro-PTC (=1cm)
- •- multifocal
- •- unifocal with pN1a (=5 foci; no extranodal spread)
- •3. Follicular thyroid cancer and oncocytic/Hurthle cell carcinoma:
- •3.1. 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)
- •3.2. Confined to thyroid or minimal extrathyroidal extension
- •Group 2 (Differentiated Thyroid Cancer on cytology/core biopsy, who has not had prior thyroid surgery yet)
- •1. Aged 16 or over
- •2. ‘low risk’ differentiated thyroid cancer confirmed by cytology or core biopsy.
- •3. cT1b-2 irrespective of molecular genetic markers
- •5. Contralateral lobe without suspicious nodule(s) (U2, or U3/U4 with Thy2 on FNAC)
- •Eligibility criteria for nested sub-study on Navio’s web-based app (software):
- •1. Have a SMS enabled mobile phone or handheld tablet with web access
- •2. Are able to use the web-based app to complete the trial questionnaires without assistance
排除标准
- •Group 1 (Hemithyroidectomy already performed prior to diagnosis):
- •1. Tumour > 4cm
- •2. Unifocal pT1a (< = 1cm) papillary thyroid cancer (PTC) and follicular thyroid cancer (FTC) (unless pN1a as listed in inclusion criteria)
- •3. Non-invasive encapsulated follicular variant of PTC
- •4. Anaplastic, poorly differentiated or medullary thyroid carcinoma
- •5. R2 resection
- •6. Gross extrathyroidal extension
- •7. pT4 or macroscopic tumour invasion of loco-regional tissues or structures
- •8. pN1a with > 5 foci or extranodal spread
- •11. 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
- •12. FTC and oncocytic/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 (Differentiated thyroid cancer on cytology or after core biopsy, who has not had prior thyroid surgery yet)
研究者
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