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RecruitingNCT06540846STUMPUpdated Jan 15, 2026

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

An observational study in Stump, sponsored by Institut Bergonié. Recruiting at 1 site in France. Open to female participants. Per ClinicalTrials.gov, last updated 2026-01-15.

Primary conditionnone(registry's first term: Disease)No conditionIs this wrong?Disease describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Institut Bergonié · Observational

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
392
Sex
Female
01

Study summary

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.

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Conditions studied

  • Stump

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Keywords

  • algorithm
  • diagnostic
  • pronostic
03

In context

Lead sponsor

Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

- Uterine smooth muscle tumors: leiomyomas, smooth muscle tumors of uncertain malignancy and leiomyossarcomas.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with a diagnosis of uterine smooth muscle tumors (leiomyomas, smooth muscle tumors of uncertain 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

Exclusion Criteria:

  • na
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
392 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

    Other: No intervention

  • Leiomyoma-leiomyosarcoma

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

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention since this is an observational study

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What researchers measure

Primary outcomes

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

    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.

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

Secondary outcomes

  1. Develop a prognostic tool for STUMP

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

    Time frame: 6 months after receiving the data.

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06540846
Lead sponsor
Institut Bergonié
Responsible party
Sponsor
First posted
Aug 6, 2024
Start date
Dec 1, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jan 15, 2026

Study contacts

Sabrina CROCE
Contact
s.croce@bordeaux.unicancer.fr
+33556333333

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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