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NCT Number: NCT06540846

Deep Learning for Histopathological Classification and Prognostication of Gynaecologic Smooth Muscle Tumours

Smooth muscle tumors of the uterus that do not fit the diagnostic criteria of benignity (such as leiomyomas) or malignancy (such as leiomyosarcomas) are called STUMP (smooth muscle tumor of uncertain malignant potential). A potential solution to this problem could be the application of predictive models using artificial intelligence (AI) to aid in the histopathological classification and prognosis of gynecological smooth muscle tumors. Deep learning using convolutional neural networks represents a specific class of machine learning, in which predictive models are trained by considering small groups of pixels in digital images and iteratively identifying salient features. In this study, we aim to develop deep learning models capable of accurately subclassifying and predicting the prognosis of gynecological smooth muscle tumors, based on histopathological features of hematoxylin and eosin (H&E) slides. The aim is to develop a diagnostic and prognostic algorithm to help pathologists better classify and diagnose uterine smooth muscle tumors and predict their clinical course.

Recruiting

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Institut Bergonie

Bordeaux, France

Location status: Recruiting

Location contact

Sabrina CROCE

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosis of uterine smooth muscle tumors (leiomyomas, smooth muscle tumors of uncertain malignancy and leiomyosarcomas), registered in the RRePS database and/or treated at Institut Bergonié or one of the participating centers.
  • Histopathological material available (kerosene blocks and/or slides).
  • The follow-up (outcome) is required for each LMS/ STUMP.

Exclusion criteria

  • na

Treatment and study plan

No intervention

Other

No intervention since this is an observational study

Primary outcomes

  1. Develop deep learning models that can accurately subclassify gynaecologic smooth muscle tumours

    Time frame: throughout the conduct of the study - an expected average of 6 months after data collection

    This project aims to improve the diagnosis and prognosis of gynecologic smooth muscle tumors, including leiomyomas (LM), leiomyosarcomas (LMS), and smooth muscle tumors of uncertain malignant potential (STUMP). In detail, a workflow comprising 2 stages will be developed to automatically classify GSMT subtypes from whole-slide images and to predict progression-free survival for patients in the LMS and STUMP groups, thereby providing clinicians with a more effective tool to improve workflow quality.

Secondary outcomes

  1. Develop a prognostic tool for STUMP

    Time frame: 6 months after receiving the data.

    Develop a model to predict progression-free survival for STUMP group based on the features extracted from Whole Slide Images.

Study contacts

Contact information is provided by the study sponsor or research team.

Sabrina CROCE

CONTACT

[email protected]

+33556333333

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Acronym: STUMP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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