Prospective Validation of the DEVA Algorithm for the Prediction of Severe Endometriosis

Endometriosis Clinical Trial

— ValDEVA  

Official title:

Prospective Validation of the DEVA Algorithm for the Prediction of Severe Endometriosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691322
• Other study ID #: ValDEVA-01
• Status: Recruiting
• Start date: October 19, 2022
• Est. completion date: January 19, 2024

Study information

• Verified date: January 2023
• Source: One Clinic
• Contact: Alba Nicolas-Boluda, PhD
• Phone: 0033782873392
• Email: alba.nicolas-boluda[@]one.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: January 19, 2024
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Female patients

• patients aged 18-45

• Patients addressed for an pelvic IRM or transvaginal echography

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Diagnostic Test:
• transvaginal ultrasound
Transvaginal ultrasound for endometriosis diagnosis (UBESS)
• MRI
MRI for endometriosis diagnosis (Enzian classification)

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal Poissy Saint Germain	Poissy	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
One Clinic

Country where clinical trial is conducted

France, 

References & Publications (1)

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;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive likelihood ratio of the algorithm classification based on the MRI or UBESS US results		1 day