EndometriosisValDEVANCT05691322
Prospective Validation of the DEVA Algorithm for the Prediction of Severe Endometriosis
An observational study of Endometriosis, run by One Clinic at 1 site in France.
Trial summary
Endometriosis is a chronic disease affecting 1 in 10 women. Its diagnosis is difficult and the time between the first symptoms and diagnosis is of about 7 years. diagnosis requires specialized imaging performed by referral practitioners for this pathology. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- transvaginal ultrasound and MRI
- How many people
- 276 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2022to 19 Jan 2024
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Female volunteers aged 18-45 years, referred for pelvic MRI or transvaginal ultrasound referral regardless of symptomatology. The practitioners performing the examinations are recognised for their experience in the diagnosis of diagnosis of endometriosis.
Who may be able to join
- Female patients
- patients aged 18-45
- Patients addressed for an pelvic IRM or transvaginal echography
Who cannot join
- Minor patients
- Patients Over 45 years of age
- Patients without social security
- Patients that do not know how to read in French
- Patients with a chronic pathology responsible of pain or handicap
- Patients with a major pelvic pathology
- Patients with more than 3 months of amenorrhea
- Patients diagnosed or suspicious of having an invasive cancer.
Trial locations and contacts
1 site in 1 country.
Arnaud Fauconnier, Prof contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Intercommunal Poissy Saint Germain
Poissy, Île-de-France Region, 78303
Arnaud Fauconnier, Prof, arnaud.fauconnier@ght-yvelinesnord.fr
About this study
Endometriosis is a chronic disease affecting 1 in 10 women. Its diagnosis is difficult and the time between the first symptoms and diagnosis is of about 7 years. diagnosis requires specialized imaging performed by referral practitioners for this pathology. According to current recommendations, non-specialized pelvic ultrasound is the recommended first-line examination. However, only reference ultrasound, performed by a doctor specialized in the disease and carried out according to a specific protocol (such as UBESS), is sufficiently reliable for diagnosis. The number of practitioners performing this type of examination is very low in France, which in practice results in a very low reliability of this strategy in real life. Pelvic MRI is also a much more reliable examination, available for review. However its access is limited. In addition, the false positive rate can be as high as 20%, particularly for minor forms of the disease.
The DEVA algorithm has been developed for the identification of women with endometriosis based on a self-administered pelvic pain symptom questionnaire (ENDOPAIN). In a preliminary study, this algorithm seems reliable for identify patients at high risk of this disease and would thus allow to triage patients requiring patients requiring an immediate MRI in order to shorten diagnostic delays. External validation of the algorithm is therefore necessary before clinical use. The main objective od this study is the prospective external validation of the diagnostic reliability of the DEVA algorithm used for the detection of women with endometriosis (visible on MRI or transvaginal ultrasound).
- Conditions
- Endometriosis
- Being tested
- transvaginal ultrasound, MRI
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal ultrasoundDiagnostic test
Transvaginal ultrasound for endometriosis diagnosis (UBESS)
MRIDiagnostic test
MRI for endometriosis diagnosis (Enzian classification)
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive likelihood ratio of the algorithm classification based on the MRI or UBESS US results
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start19 Oct 2022
- Primary completion19 Oct 2023 (estimated)
- Study completion19 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- One Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691322
- Sponsor's protocol ID
- ValDEVA-01
- Acronym
- ValDEVA
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fauconnier A, Drioueche H, Huchon C, Du Cheyron J, Indersie E, Candau Y, Panel P, Fritel X. Early identification of women with endometriosis by means of a simple patient-completed questionnaire screening tool: a diagnostic study. Fertil Steril. 2021 Dec;116(6):1580-1589. doi: 10.1016/j.fertnstert.2021.07.1205. Epub 2021 Sep 17.
PubMed 34538656
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of the DEVA Algorithm for the Prediction of Severe Endometriosis
- ClinicalTrials.gov ID
- NCT05691322
- Acronym / sponsor ID
- ValDEVA / ValDEVA-01
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- One ClinicUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 19 Oct 2023 (estimated)
- Study completion
- 19 Jan 2024 (estimated)
- First posted
- 20 Jan 2023 (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.
Endometriosis is a chronic disease affecting 1 in 10 women. Its diagnosis is difficult and the time between the first symptoms and diagnosis is of about 7 years. diagnosis requires specialized imaging performed by referral practitioners for this pathology. According to current recommendations, non-specialized pelvic ultrasound is the recommended first-line examination. However, only reference ultrasound, performed by a doctor specialized in the disease and carried out according to a specific protocol (such as UBESS), is sufficiently reliable for diagnosis. The number of practitioners performing this type of examination is very low in France, which in practice results in a very low reliability of this strategy in real life. Pelvic MRI is also a much more reliable examination, available for review. However its access is limited. In addition, the false positive rate can be as high as 20%, particularly for minor forms of the disease.
The DEVA algorithm has been developed for the identification of women with endometriosis based on a self-administered pelvic pain symptom questionnaire (ENDOPAIN). In a preliminary study, this algorithm seems reliable for identify patients at high risk of this disease and would thus allow to triage patients requiring patients requiring an immediate MRI in order to shorten diagnostic delays. External validation of the algorithm is therefore necessary before clinical use. The main objective od this study is the prospective external validation of the diagnostic reliability of the DEVA algorithm used for the detection of women with endometriosis (visible on MRI or transvaginal ultrasound).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female volunteers aged 18-45 years, referred for pelvic MRI or transvaginal ultrasound referral regardless of symptomatology. The practitioners performing the examinations are recognised for their experience in the diagnosis of diagnosis of endometriosis.
Key inclusion criteria (3 listed)
- Female patients
- patients aged 18-45
- Patients addressed for an pelvic IRM or transvaginal echography
Key exclusion criteria (8 listed)
- Minor patients
- Patients Over 45 years of age
- Patients without social security
- Patients that do not know how to read in French
- Patients with a chronic pathology responsible of pain or handicap
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 |
|---|---|---|
| transvaginal ultrasoundTransvaginal ultrasound for endometriosis diagnosis (UBESS) | Diagnostic test | – |
| MRIMRI for endometriosis diagnosis (Enzian classification) | Diagnostic test | – |
Primary outcome
Positive likelihood ratio of the algorithm classification based on the MRI or UBESS US results
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Results publication: PubMed 34538656Fauconnier A, Drioueche H, Huchon C, Du Cheyron J, Indersie E, Candau Y, Panel P, Fritel X. Early identification of women with endometriosis by means of a simple patient-completed questionnaire screening tool: a diagnostic study. Fertil Steril. 2021 Dec;116(6):1580-1589. doi: 10.1016/j.fertnstert.2021.07.1205. Epub 2021 Sep 17.
- Individual participant dataSharing planned: No
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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.
Arnaud Fauconnier, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by One Clinic at 1 site in France.
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 3 inclusion and 8 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 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Alba Nicolas-Boluda, PhD (0033782873392, alba.nicolas-boluda@one.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive likelihood ratio of the algorithm classification based on the MRI or UBESS US results (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05691322, which also lists 1 linked publication.
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 20 Jan 2023.