Development and Evaluation of an Artificial Intelligence Tool for Colposcopy Assistance
IACOL
1 other identifier
observational
1,000
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2024
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedFebruary 1, 2024
January 1, 2024
8 months
January 4, 2024
January 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Development of an algorithm to help interpret colposcopy images
Creation of an imaging database with correlation to clinical and histological data, using data from care at the Pitié-Salpêtrière Hospital. A hundred cases will be selected for the study from the hundreds available in the department. Annotation of colposcopy photos according to the recommendations of the French Society of Colposcopy and Cervico Vaginal Pathology (SFCPCV), then correlation with histological data. Development of an algorithm for recognizing and analyzing colposcopy photos, with the help of a computer science student, using the analyzed data.
4 month after inclusion
Secondary Outcomes (1)
Evaluate the effectiveness of this algorithm
4 month after inclusion
Interventions
data collection from the patient's medical record. The data will be that of routine care, with no procedures added by the research.
Eligibility Criteria
\- Adult patients who underwent colposcopy with directed biopsies at La Pitié-Salpêtrière between September 1, 2022 and December 31, 2023
You may qualify if:
- Adult patients who underwent colposcopy with directed biopsies at La Pitié-Salpêtrière between September 1, 2022 and December 31, 2023
- Known clinical context (why the patient underwent colposcopy)
- Histological results of cervical biopsies (+/- conization or even hysterectomy) known
- Images available (photographs of the cervix without preparation, after application of acetic acid and after application of lugol)
- Informed of the study and not opposing the use of their data
You may not qualify if:
- Patients who do not speak French
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Sorbonne Universitycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 2 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2024
First Posted
January 17, 2024
Study Start
March 1, 2024
Primary Completion
October 31, 2024
Study Completion
October 31, 2024
Last Updated
February 1, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal.
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.