NL-OMON55252尚未招募不适用
De-escalation of treatment for Papillary Thyroid Cancer followed by Active Surveillance * a pilot study - Dutch De-escalation Pilot Study (DDPS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
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
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •- Able to undergo surgery
- •- Age of 18 years and older
- •- Diagnosed with unilateral papillary thyroid cancer with a diameter of 1-4 cm,
- •as defined by:
- •o Histologically proven well differentiated (classic or follicular variant) PTC
- •after diagnostic hemithyroidectomy 1-4cm
- •o Cytologically proven Bethesda 6
- •o Cytologically proven Bethesda 5 nodule with confirmed BRAF mutation
- •- Size of index nodule / tumor must be between 1 and 4cm, measured by
- •ultrasound or on histopathology. Histopathology may overrule ultrasound
- •measurements.
- •- Ultrasound of the neck excluding lymph node involvement
- •- Signed informed consent by patient
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Positive resection margins or extensive extrathyroidal extension as defined
- •for in the 8th edition of the AJCC/TNM classification of thyroid cancer for
- •extension of a T3 tumor upon histology or ultrasound.
- •- Lymph node involvement confirmed by ultrasound and FNA prior to randomization
- •- Multifocality
- •- Vascular invasion
- •- Aggressive histology (e.g. poorly differentiated, tall cell, columnar cell,
- •hobnail variant, diffuse sclerosing variant PTC)
- •- Certain classification of NIFTP on histology
- •- A contralateral nodule requiring intervention (if applicable)
- •- Pregnant women
- •- Insufficient understanding of the Dutch language to understand the study
- •- Minors (age < 18 years) and incapacitated subjects do not meet the
- •eligibility criteria and will therefore not be enrolled
研究者
相似试验
招募中
不适用
Dutch De-escalation pilot StudyNL-OMON22164o sponsors12
已完成
不适用
Treatment decision making in papillary thyroid cancer: an online discrete choice experiment surveyPapillary thyroid cancerACTRN12617000066381Sydney School of Public Health, University of Sydney2,000
进行中（未招募）
不适用
Treatment of poorly differentiated thyroid carcinoma resistant to conventional therapy, with reverse transcriptase inhibitors. - NDpatients affected by thyroid carcinomaMedDRA version: 9.1Level: HLTClassification code 10043747Term: Thyroid neoplasmsEUCTR2007-000215-28-ITAZIENDA OSPEDALIERA SENESE
已完成
不适用
Parathyroid hormone in the recovery from hip fractures: a pilot studyHip fractureISRCTN03362357orth Bristol NHS Trust (UK)40
已完成
不适用
Hyperthyroidism controlled by administration of blocking and replacement therapy before inpatient radioisotope therapy for the patient of Graves' diseaseGraves'diseaseJPRN-UMIN000022261Ito Hospital23