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Clinical Trials in the Netherlands / NCT06301945
Recruiting Observational

Artificial Intelligence Prediction Tool in Thymic Epithelial Tumors

NCT06301945 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Erasmus Medical Center
Phase
Observational
Started
2023-08-01
Last updated
2024-03-27

Condition(s) studied

Thymic Epithelial TumorThymic CarcinomaThymomaThymoma and Thymic Carcinoma

Investigational drug(s) / intervention(s)

Artificial Intelligence DiagnosticsRecurrence Prediction Tool

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

Recurrence Prediction Tool: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Erasmus MC Rotterdam South Holland Recruiting

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Other trials for the same condition

Nivolumab in Patients With Type B3 Thymoma and Thymic Carcinoma (NIVOTHYM) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06301945 on ClinicalTrials.gov ↗ ← All trials in the Netherlands