Clinical trial NCT06208319: Development and Evaluation of an Artificial Intelligence Tool for Colposcopy Assistance
Official title: Development and Evaluation of an Artificial Intelligence Tool for Colposcopy Assistance
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Cancer
HSIL
LSIL
Cervical Ectropion
Keywords: Artificial Intelligence
Colposcopy
Machine Learning
Algorithm
Papillomavirus
Cervical Cancer
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Sorbonne University
First posted: 2024-01-17
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Adult patients who underwent colposcopy with directed biopsies at La Pitié-Salpêtrière between September 1, 2022 and December 31, 2023

Brief summary: Project aiming to develop an algorithm to help the interpretation of colposcopy images, then to evaluate the effectiveness of this algorithm by using it on new cases and comparing the results obtained to the impression of expert clinicians

Detailed description: Due to the increase in the number of colposcopies following changes in recommendations regarding cervical cancer screening, the investigators wondered about the benefit of assistance provided by the computer tool. Several teams have already developed algorithms to aid in the interpretation of colposcopy, but the studies were carried out in countries that do not have the colposcopic expertise of French practitioners, and no algorithm has has demonstrated its effectiveness to our knowledge, the different results being inhomogeneous. The investigators therefore wanted to develop an algorithm to aid colposcopy based on clinical cases carried out by practitioners considered experts, then evaluate its effectiveness.

The investigators manually collect data concerning adult patients who underwent colposcopy by an expert doctor at La Pitié-Salpêtrière between September 1, 2022 and December 31, 2023, for whom the photographs of the colposcopic examination (without staining, after acid acetic and after Lugol) are available and usable and for which the clinical context is known. If a biopsy has been performed, the histological result is considered the gold standard. If this is not the case (normal and satisfactory colposcopy), the investigators consider by default that the histology is normal. The investigators excluded all patients for whom photographs were of poor quality or unavailable.

Development of the algorithm with the help of a computer science student, aiming to answer the following 2 questions:

* assumed histological result
* localization of the targeted biopsy if necessary

Evaluation of the algorithm: use of the algorithm for new cases, then comparison of the results obtained with the response given by expert clinicians (reading of images by 2 colposcopists). The aim will be to highlight the non-inferiority of the algorithm.

Eligibility criteria: Inclusion Criteria:

1. Adult patients who underwent colposcopy with directed biopsies at La Pitié-Salpêtrière between September 1, 2022 and December 31, 2023
2. Known clinical context (why the patient underwent colposcopy)
3. Histological results of cervical biopsies (+/- conization or even hysterectomy) known
4. Images available (photographs of the cervix without preparation, after application of acetic acid and after application of lugol)
5. Informed of the study and not opposing the use of their data

Exclusion Criteria:

* Patients who do not speak French

Primary outcomes:
measure: Development of an algorithm to help interpret colposcopy images
timeFrame: 4 month after inclusion
Secondary outcomes:
measure: Evaluate the effectiveness of this algorithm
timeFrame: 4 month after inclusion
Other outcomes:
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Study officials:
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