Prospective Validation of the DEVA Algorithm for the Prediction of Severe Endometriosis (ValDEVA)

January 17, 2023 updated by: One Clinic

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive likelihood ratio of the algorithm classification based on the MRI or UBESS US results
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

One Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2022

Primary Completion (Anticipated)

October 19, 2023

Study Completion (Anticipated)

January 19, 2024

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ValDEVA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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