Artificial Intelligence Prediction Tool in Thymic Epithelial Tumors

N/ARecruitingNCT06301945

Erasmus Medical Center1,020 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,020

Conditions

Thymic Epithelial Tumor Thymic Carcinoma Thymoma Thymoma and Thymic Carcinoma

Interventions

Artificial Intelligence DiagnosticsDIAGNOSTIC_TEST

AI Diagnostics uses advanced algorithms for precise histological image analysis to help diagnose disease, including subtype.

Recurrence Prediction ToolDIAGNOSTIC_TEST

This AI tool evaluates thymic tumour data and other clinical data and calculates the risk of recurrence, with the aim of analysing whether there is an association with specific subtypes of thymic epithelial tumours and clinical data.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 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.

Outcomes

Primary Outcomes

WP1 - Databases/Data Pre-processing

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.

Time frame: M1-M18

Secondary Outcomes

WP2 - Deep Learning-Model for TET Classification and Recurrence Prediction

This outcome aims to create an AI-framework with two principal goals. First, investigate TET-subtypes using four different models emphasizing cell type, morphological structures, and a combination. Second, classify patients based on recurrence outcome within 5 years. An ablation study will be conducted with state-of-the-art deep learning classifiers (ResNet, Inception).

Time frame: M6-M32