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临床试验/NCT06154863
NCT06154863尚未招募不适用

Evaluation of Recurrence in Patients With Differentiated Thyroid Cancer

Assiut University0 个研究点目标入组 100 人开始时间: 2024年3月1日最近更新:
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试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Assessment of recurrence-free survival after RAI therapy in patients with thyroid cancer.

研究概览

简要总结

The aim of this study is to assess the recurrence-free survival (RFS) rate and recurrence-related factors, especially the relationship between RFS and RAI dose, in patients who received RAI after thyroidectomy.

详细描述

Thyroid cancer is the most frequent cancer of the endocrine system, and its incidence is constantly rising worldwide. This is mainly because of advances in examination modalities that have made it possible to detect smaller cancers at an early stage.

Owing to advancements in screening techniques and treatment methods, the number of patients who die from thyroid cancer is small compared to the incidence.[1]

The most common type of thyroid cancer is differentiated thyroid cancer (DTC), which includes papillary and follicular carcinomas. Women are three times more likely to develop thyroid cancer than men. [2] Adjuvant RAI131 (AT) is recommended post thyroidectomy, because of its therapeutic impact on micro-invasions or micro-metastases, to reduce the likelihood of recurrence in patients who do not have metastases but have risk of recurrence according to the Japanese guidelines and American Thyroid Association guidelines [3],[4].

AT could prolong the survival of patients with intermediate-risk DTC [5]. Additionally, a meta-analysis has shown that AT is effective in reducing recurrence in some studies but not in others, and the effect of AT on recurrence prevention, especially in high-risk DTC, remains unclear.[6].

Although there are reliable reports discussing the relationship between the success or failure of remnant ablation [7],[8], recurrence after AT is rarely reported and the number of cases is small. In addition, no study has so far discussed the relationship between the success or failure of AT or remnant ablation and recurrence or death [9],[10].

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with DTC (differentiated thyroid cancer) who underwent total or subtotal thyroidectomy without distant metastasis and gross residual tumors.
  • Followed by ablation with RAI and underwent post RAI whole body scan.
  • Having baseline TG (thyroglobulin), Anti-TG antibodies (anti thyroglobulin) and neck US.
  • Patients with lymph node metastasis will be included if their lymph nodes had been dissected and no unresectable disease remained.

排除标准

  • Patients who received RAI and missed follow-up.
  • Patients with no surgical or pathological data.

结局指标

主要结局

Assessment of recurrence-free survival after RAI therapy in patients with thyroid cancer.

时间窗: 2 years

Assessment of recurrence-free survival after radioactive iodine-131 therapy in patients with differentiated thyroid carcinoma.

次要结局

  • Correlation analysis of I-131 SPECT/CT uptake parameters with the success ablation treatment of thyroid remnant.(2 years)

研究者

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

Sara Salah Mahmoud

Principal Investigator

Assiut University

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