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Artificial Intelligence Prediction Tool in Thymic Epithelial Tumors

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06301945
Acronym
INTHYM
Enrollment
1020
Registered
2024-03-08
Start date
2023-08-01
Completion date
2027-08-01
Last updated
2024-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thymic Carcinoma, Thymic Epithelial Tumor, Thymoma, Thymoma and Thymic Carcinoma

Keywords

Artificial Intelligence, Digital pathology

Brief 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.

Interventions

DIAGNOSTIC_TESTArtificial Intelligence Diagnostics

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

DIAGNOSTIC_TESTRecurrence 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.

Sponsors

Maastro Clinic, The Netherlands
CollaboratorOTHER
Hospices Civils de Lyon
CollaboratorOTHER
Erasmus Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

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.

Design outcomes

Primary

MeasureTime frameDescription
WP1 - Databases/Data Pre-processingM1-M18The 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.

Secondary

MeasureTime frameDescription
WP2 - Deep Learning-Model for TET Classification and Recurrence PredictionM6-M32This 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).

Other

MeasureTime frameDescription
WP3: Clinical EvaluationM6-M36AI-models 1-3 will be built and validated on the EMC-database, while AI-model 4 will be built on the MUMC+-database and validated on both. Model performance will be assessed using sensitivity, specificity, negative/positive predictive value. Decision analysis curves will quantify the clinical benefit, identifying patient groups with the largest utility.

Countries

Netherlands

Contacts

Primary ContactAnna Salut Esteve Domínguez
a.estevedominguez@erasmusmc.nl0107043491

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026