跳至主要内容
临床试验/NCT06301945
NCT06301945招募中不适用

Artificial Intelligence for Histopathological Classification and Recurrence Prediction of Thymic Epithelial Tumors

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 1,020 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,020
试验地点
1
主要终点
WP1 - Databases/Data Pre-processing

研究概览

简要总结

Thymic epithelial tumors are rare neoplasms in the anterior mediastinum. The cornerstone of the treatment is surgical resection. Administration of postoperative radiotherapy is usually indicated in patients with more extensive local disease, incomplete resection and/or more aggressive subtypes, defined by the WHO histopathological classification.

In this classification thymoma types A, AB, B1, B2, B3, and thymic carcinoma are distinguished. Studies have shown large discordances between pathologists in subtyping these tumors. Moreover, the WHO classification alone does not accurately predict the risk of recurrence, as within subtypes patients have divergent prognoses.

The investigators will develop AI models using digital pathology and relevant clinical variables to improve the accuracy of histopathological classification of thymic epithelial tumors, and to better predict the risk of recurrence.

In this multicentric and international project three existing databases will be used from Rotterdam, Maastricht and Lyon. For all models one database will be used to build AI models, and the other two for external validation.

The ultimate goal of this project is to develop AI models that support the pathologist in correctly subtyping thymic epithelial tumors, in order to prevent patients from under- or overtreatment with adjuvant radiotherapy.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Participants with specific diagnoses are eligible for inclusion in the study. The eligible diagnoses include various subtypes of thymoma and thymic carcinoma, specifically:
  • Thymoma A
  • Thymoma AB
  • Thymoma B1
  • Thymoma B2
  • Thymoma B3
  • Thymic Carcinoma
  • Inclusion is based on a consensus diagnosis with a level of agreement less than 70%. This criterion is applied during the training phase of the model.
  • Recurrence Criteria:
  • Participants with a documented recurrence outcome within a 5-year period are considered eligible for this aspect of the study. This criterion is primarily applied during the validation phase.

排除标准

  • 未提供

结局指标

主要结局

WP1 - Databases/Data Pre-processing

时间窗: M1-M18

The EMC-dataset includes 179 TET-patients classified by experienced TET-pathologists. Cases with good agreement between pathologists will be used for training AI-models. Evaluation includes digitized pathology slides assessed by an international expert-panel. The MUMC-database (137 patients) and CHUL-database (181 patients) provide additional data, including clinical variables. Relevant factors include age, gender, tumor volume, stage, completeness of resection, autoimmune disorders, and treatment details.

次要结局

  • WP2 - Deep Learning-Model for TET Classification and Recurrence Prediction(M6-M32)

研究者

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

Anna Salut Esteve Domínguez

PhD student

Erasmus Medical Center

研究点 (1)

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