跳至主要内容
临床试验/NCT03363347
NCT03363347已完成不适用

Association Between BRAF V600E and Redifferentiation Therapy in Patients With Radioiodine-refractory Papillary Thyroid Cancer

Heidelberg University0 个研究点目标入组 25 人开始时间: 2008年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
25
主要终点
Response to radioiodine therapy after redifferentiation

研究概览

简要总结

Papillary thyroid cancer (PTC) is the most common neoplasia in the thyroid gland. The combination of surgery, followed by radioiodine therapy (RIT) and thyroid-stimulating hormone (TSH) suppressive therapy is usually a curative option for differentiated thyroid cancer (DTC). Although DTC has a good prognosis generally, it is problematic when dedifferentiation is suspected and radioiodine refractoriness presumed. One possible therapy option for redifferentiation is the pretreatment with retinoids. From 2008 to 2014 there were 13 patients with PTC who were treated with retinoids after thyroidectomy before a further course of radioiodine. A recent study has shown that the efficacy of Selumetinib, another option for redifferentiation depends on the mutational status of the treated patient. In this retrospective study the investigators looked for a similar association between BRAF V600E and redifferentiation therapy with retinoids. As retinoids have fewer side effects compared to TKI, it is worth performing studies to assess the importance of genetic marker for the response and to estimate the chances of this specific patient collective. BRAF V600E seems to be associated with better long-term response after redifferentiation therapy with 13-cis RA in RAI-R PTC. Therefore, evaluation of BRAF mutational status prior to redifferentiation therapy could be beneficial for predicting response.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
24 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Radioiodine refractory papillary thyroid cancer

Patients with radioiodine refractory papillary thyroid cancer who received redifferentiation therapy with retinoid acid.

干预措施: Redifferentiation with retinoid acid (Drug)

结局指标

主要结局

Response to radioiodine therapy after redifferentiation

时间窗: 7 years

Redifferentiation therapy was performed using 13-cis RA (Isotretinoin, Roaccutan®) with a daily dose of orally 1,5mg/kg for up to two months. For assessment of clinical outcome of 13-cis retinoic acid treatment three parameters, tumor size, thyroglobulin levels and radioiodine uptake were considered in a graduated model.

次要结局

  • Parameter radioiodine-uptake (RI-Uptake)(7 years)
  • Parameter tumor size(7 years)
  • Parameter thyroglobulin levels (serum Tg)(7 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Kopf MD

Head of the Clinical Study Center for Diabetes Research

Heidelberg University

相似试验