Endometriosis PelvicENDOMEDNCT05722314
ENDOMED: Evaluation of the Evolution of Endometriosis Lesions on Imaging Under Medical Treatment
An observational study of Endometriosis Pelvic, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Endometriosis is a difficult disease to diagnose because the symptoms are varied, unspecific and inconsistent from one patient to another. Magnetic resonance imaging is the gold standard for the diagnosis, staging and follow-up of this pathology. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Endometriosis Pelvic
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 1 Nov 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 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients whose MRI results are in favor of deep endometriosis, taking medical treatment or included in a MAP program or in whom it is agreed to withhold treatment (by patient choice, refusal of initial medical or surgical management, desire for spontaneous pregnancy, etc.).
Who may be able to join
- No history of endometriosis surgery
- Diagnosis of endometriosis suspected by an MRI performed or reviewed in a reference center
- Presence of symptomatology requiring medical treatment
Who cannot join
- Pregnant or postmenopausal patient
- Not speaking French, not affiliated to the french social security system
- Minors or under guardianship
- Need for surgical management in the first instance
- Contraindication to MRI (claustrophobia, renal insufficiency, gadolinium allergy, intracorporeal presence of metallic implant)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise Laclautre
Claire FIGUIER
About this study
Official title: ENDOMED: Evaluation of the Evolution of Endometriosis Lesions on MRI Before and After Medical Treatment.
Endometriosis is a difficult disease to diagnose because the symptoms are varied, unspecific and inconsistent from one patient to another. Magnetic resonance imaging is the gold standard for the diagnosis, staging and follow-up of this pathology. Moreover, the management of endometriosis can be medical or surgical depending on the severity and location of the lesions and the patient's expectations. The recommendations of the National College of Obstetricians and Gynecologists and the French National Health Authority are medical treatment first in a certain number of situations. These patients undergoing medical treatment then require close clinical and radiological follow-up in order to evaluate the effectiveness of the treatment and the evolution of the disease. The literature describes the appearance of endometriosis lesions on pelvic MRI quite well for the establishment of the diagnosis, but there are few data on the evolution and imaging description of these lesions when hormonal treatment is in progress. Thus, we decided to evaluate and describe the evolution of endometriosis lesions on magnetic resonance imaging under medical treatment and to examine a correlation between this radiological evolution and the clinical evolution of the patients.
Read the detailed description
D-0 Consultation: The patient is referred to one of the gynecologists in our department to assess a suspected endometriosis.
If the symptomatology is suggestive of endometriosis and the patient has not yet had an MRI, it will be performed in the department. In all cases, the inclusion MRI will be performed or reviewed by the department's referring radiologists.
The patient is then offered to participate in the NoEndo (national observatory of endometriosis) project. Via this application, the patient will be able to fill in questionnaires evaluating her quality of life and pain (SF 36, EHP 30, EHP 5, FSFI, GIQLI).
In addition, the patient's history, age, BMI, type and duration of treatment and clinical examination will be collected via the NoEndo application. The initial therapeutic choice between hormonal treatment (with details of the choice of the molecule and dosage) or first management in MAP (medical assistance for procreation) (with details of the therapeutic sequence chosen) or therapeutic abstention (with details of the reason) will be collected in the NoEndo application.
M-6 Consultation: At 6 months of treatment, the patient will be seen in consultation, to assess her tolerance to the treatment undertaken. She will be asked to fill in the questionnaires evaluating her quality of life and pain. Any change in treatment or therapeutic strategy will be notified.
Patient compliance and whether or not amenorrhea was achieved will be recorded. M-12 MRI: At 12 months, the patient will have a new MRI check-up in our reference center at the CHU of Clermont-Ferrand according to the same modalities as the first examination and according to the service protocol.
M-12 Consultation: We will see the patient again in consultation, to evaluate again her tolerance of the treatment as well as her compliance. We will evaluate her pain as well as the results of the quality of life questionnaires that she will have filled out beforehand via the NoEndo application. We will also analyze the results of the MRI.
We will then discuss with the patient the various possible management options for the future: continuation of medical treatment, PMA course, surgery.
If the patient is or has been pregnant before the one-year MRI, the information will be notified and the surveillance MRI may be delayed.
- Conditions
- Endometriosis Pelvic
- Keywords
- Endometriosis, hormonal treatment, Endometrioma, MRI, Deep Endometriosis, rectovaginal nodule
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of lesions
To compare endometriosis lesions on pelvic MRI before and after one year of hormonal treatment. The size, appearance and location of the lesions will be compared
Measured: 2 years
Secondary outcomes (2)
Clinical evaluation
Evaluate the clinical evolution of patients undergoing medical treatment, based on the evolution of the Medical Outcomes Study Short Form (MOS SF-36) score, generalist quality of life questionnaire used in endometriosis
Measured: 2 years
Clinical evaluation 2
Evaluate the clinical evolution of patients undergoing medical treatment, based on the evolution of the Endometriosis Health Profile 30 (EHP-30) score, quality of life questionnaire specialized for endometriosis.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Sep 2022
- Primary completion1 Sep 2022
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis PelvicStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Figuier, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722314
- Sponsor's protocol ID
- ENDOMED FIGUIER
- Acronym
- ENDOMED
- Status last verified
- Nov 2022
- First submitted
- 22 Dec 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDOMED: Evaluation of the Evolution of Endometriosis Lesions on MRI Before and After Medical Treatment.
- ClinicalTrials.gov ID
- NCT05722314
- Acronym / sponsor ID
- ENDOMED / ENDOMED FIGUIER
- Conditions
- Endometriosis Pelvic
- Keywords
- Endometriosis, hormonal treatment, Endometrioma, MRI, Deep Endometriosis, rectovaginal nodule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 10 Feb 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 difficult disease to diagnose because the symptoms are varied, unspecific and inconsistent from one patient to another. Magnetic resonance imaging is the gold standard for the diagnosis, staging and follow-up of this pathology. Moreover, the management of endometriosis can be medical or surgical depending on the severity and location of the lesions and the patient's expectations. The recommendations of the National College of Obstetricians and Gynecologists and the French National Health Authority are medical treatment first in a certain number of situations. These patients undergoing medical treatment then require close clinical and radiological follow-up in order to evaluate the effectiveness of the treatment and the evolution of the disease. The literature describes the appearance of endometriosis lesions on pelvic MRI quite well for the establishment of the diagnosis, but there are few data on the evolution and imaging description of these lesions when hormonal treatment is in progress. Thus, we decided to evaluate and describe the evolution of endometriosis lesions on magnetic resonance imaging under medical treatment and to examine a correlation between this radiological evolution and the clinical evolution of the patients.
Detailed description
D-0 Consultation: The patient is referred to one of the gynecologists in our department to assess a suspected endometriosis.
If the symptomatology is suggestive of endometriosis and the patient has not yet had an MRI, it will be performed in the department. In all cases, the inclusion MRI will be performed or reviewed by the department's referring radiologists.
The patient is then offered to participate in the NoEndo (national observatory of endometriosis) project. Via this application, the patient will be able to fill in questionnaires evaluating her quality of life and pain (SF 36, EHP 30, EHP 5, FSFI, GIQLI).
In addition, the patient's history, age, BMI, type and duration of treatment and clinical examination will be collected via the NoEndo application. The initial therapeutic choice between hormonal treatment (with details of the choice of the molecule and dosage) or first management in MAP (medical assistance for procreation) (with details of the therapeutic sequence chosen) or therapeutic abstention (with details of the reason) will be collected in the NoEndo application.
M-6 Consultation: At 6 months of treatment, the patient will be seen in consultation, to assess her tolerance to the treatment undertaken. She will be asked to fill in the questionnaires evaluating her quality of life and pain. Any change in treatment or therapeutic strategy will be notified.
Patient compliance and whether or not amenorrhea was achieved will be recorded. M-12 MRI: At 12 months, the patient will have a new MRI check-up in our reference center at the CHU of Clermont-Ferrand according to the same modalities as the first examination and according to the service protocol.
M-12 Consultation: We will see the patient again in consultation, to evaluate again her tolerance of the treatment as well as her compliance. We will evaluate her pain as well as the results of the quality of life questionnaires that she will have filled out beforehand via the NoEndo application. We will also analyze the results of the MRI.
We will then discuss with the patient the various possible management options for the future: continuation of medical treatment, PMA course, surgery.
If the patient is or has been pregnant before the one-year MRI, the information will be notified and the surveillance MRI may be delayed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients whose MRI results are in favor of deep endometriosis, taking medical treatment or included in a MAP program or in whom it is agreed to withhold treatment (by patient choice, refusal of initial medical or surgical management, desire for spontaneous pregnancy, etc.).
Key inclusion criteria (3 listed)
- No history of endometriosis surgery
- Diagnosis of endometriosis suspected by an MRI performed or reviewed in a reference center
- Presence of symptomatology requiring medical treatment
Key exclusion criteria (5 listed)
- Pregnant or postmenopausal patient
- Not speaking French, not affiliated to the french social security system
- Minors or under guardianship
- Need for surgical management in the first instance
- Contraindication to MRI (claustrophobia, renal insufficiency, gadolinium allergy, intracorporeal presence of metallic implant)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evolution of lesions
Time frame: 2 years
To compare endometriosis lesions on pelvic MRI before and after one year of hormonal treatment. The size, appearance and location of the lesions will be compared
2 secondary outcomes
Clinical evaluation
Time frame: 2 years
Clinical evaluation 2
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- 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.
Claire Figuier principal investigator
University Hospital, Clermont-Ferrand
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 Pelvic, run by University Hospital, Clermont-Ferrand 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 5 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 10 Feb 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 Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of lesions (time frame: 2 years). 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 10 Feb 2023.