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

NCT ID: NCT06540846

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

392 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stump

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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STUMP cohort

Smooth muscle tumors of the uterus that do not fit the diagnostic criteria of benignity (such as leiomyomas) or malignancy (such as leiomyosarcomas) : smooth muscle tumor of uncertain malignant potential

No intervention

Intervention Type OTHER

No intervention since this is an observational study

Leiomyoma-leiomyosarcoma

Smooth muscle tumors of the uterus that do fit the diagnostic criteria of benignity (such as leiomyomas) or malignancy (such as leiomyosarcomas)

No intervention

Intervention Type OTHER

No intervention since this is an observational study

Interventions

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No intervention

No intervention since this is an observational study

Intervention Type OTHER

Eligibility Criteria

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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 BergoniƩ 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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut BergoniƩ

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Bergonie

Bordeaux, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sabrina CROCE

Role: CONTACT

+33556333333

Facility Contacts

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Sabrina CROCE

Role: primary

Other Identifiers

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IB2023-STUMP

Identifier Type: -

Identifier Source: org_study_id

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