Cervical CancerIACOLNCT06208319
Development and Evaluation of an Artificial Intelligence Tool for Colposcopy Assistance
An observational study of Cervical Cancer and HSIL, run by Assistance Publique - Hôpitaux de Paris.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, HSIL, LSIL
- What is being tested?
- data collection
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Oct 2024
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: - Adult patients who underwent colposcopy with directed biopsies at La Pitié-Salpêtrière between September 1, 2022 and December 31, 2023
Who may be able to join
- 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
Who cannot join
- Patients who do not speak French
Trial locations and contacts
No sites are listed yet.
Pierre MATHON contact
About this study
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
Read the 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.
- Conditions
- Cervical Cancer, HSIL, LSIL, Cervical Ectropion
- Being tested
- data collection
- Keywords
- Artificial Intelligence, Colposcopy, Machine Learning, Algorithm, Papillomavirus, Cervical Cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
data collection from the patient's medical record. The data will be that of routine care, with no procedures added by the research.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 month after inclusion
Secondary outcomes (1)
Evaluate the effectiveness of this algorithm
Comparison of algorithm correlation rate to histological data with clinician correlation rate to histological data
Measured: 4 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Sorbonne University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208319
- Sponsor's protocol ID
- APHP231740
- Acronym
- IACOL
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Artificial Intelligence Tool for Colposcopy Assistance
- ClinicalTrials.gov ID
- NCT06208319
- Acronym / sponsor ID
- IACOL / APHP231740
- Conditions
- Cervical Cancer, HSIL, LSIL, Cervical Ectropion
- Keywords
- Artificial Intelligence, Colposcopy, Machine Learning, Algorithm, Papillomavirus, Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Sorbonne University
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Adult patients who underwent colposcopy with directed biopsies at La Pitié-Salpêtrière between September 1, 2022 and December 31, 2023
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who do not speak French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectiondata collection from the patient's medical record. The data will be that of routine care, with no procedures added by the research. | Other | – |
Primary outcome
Development of an algorithm to help interpret colposcopy images
Time frame: 4 month after inclusion
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.
1 secondary outcome
Evaluate the effectiveness of this algorithm
Time frame: 4 month after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre MATHON contact
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and HSIL, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geoffroy CANLORBE, MD, PhD (+ 1 42 17 81 11 ext. +33, geoffroy.canlorbe@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of an algorithm to help interpret colposcopy images (time frame: 4 month after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.