EndometriosisNCT04846582
An Observational Study of Patients With Endometriosis to Evaluate the Usefulness of the MEDL Score, a New Method for Evaluating Endometriosis Using MRI
An observational study of Endometriosis, run by Chugai Pharmaceutical at 1 site in Brazil.
Trial summary
The purpose of this study is to confirm the reproducibility that the MEDL score can be evaluated by Magnetic Resonance Imaging (MRI) in the similar way as laparoscopy, the gold standard for the evaluation of the disease state of endometriosis, in order to establish the MEDL score, a new evaluation index for… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometriosis
- How many people
- 73 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Jul 2021to 10 Jan 2023
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with endometriosis diagnosed by imaging and who are candidates for fertility-preserving surgery
Who may be able to join
- Patients who consent to use their data in this study
- Patients with endometriosis diagnosed by transvaginal ultrasound (TVUS) and/or MRI
- Patients undergoing fertility-preserving surgery
- Patients with pain due to endometriosis
- Patients with endometriotic lesions other than ovarian cysts confirmed by MRI (concomitant ovarian cysts can be recruited)
- Patients with the following patient clinical information (TVUS is not mandatory when archived data is used)
- Patient clinical information: Preoperative MR images, videos of laparoscopic surgery, pathological evaluation of endometriosis, videos of preoperative TVUS, pain information related to endometriosis, information about infertility before surgery, information on QOL, information on postoperative recurrence, information on surgical difficulty, operating time, length of hospital stay for surgical operation, age, history of treatment (drugs, surgery), anamnesis and complication, history of endometriosis, age at menarche, menstrual cycle, date of surgery, date of MR image acquisition, operative procedure and history of pregnancy and childbirth.
Who cannot join
- Patients who had surgery for endometriosis prior to the surgery included in this study
- Patients deemed inappropriate by the principal investigator
- Patients who obtained their voluntary consent but later withdrew their consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Method for Evaluating Endometriosis Using MRI: A Study on the MEDL Score
The purpose of this study is to confirm the reproducibility that the MEDL score can be evaluated by Magnetic Resonance Imaging (MRI) in the similar way as laparoscopy, the gold standard for the evaluation of the disease state of endometriosis, in order to establish the MEDL score, a new evaluation index for endometriosis using MRI. Approximately 70-90 patients with endometriosis diagnosed by imaging and who are candidates for fertility-preserving surgery will be recruited retrospectively or prospectively, and the disease status of endometriosis will be evaluated using preoperative MR images, laparoscopic surgery videos, etc. The relationship between the condition and clinical symptoms, such as pain, is also considered.
- Conditions
- Endometriosis
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of MEDL score assessed by MRI and laparoscopy
Correlation coefficient of total MEDL score assessed by preoperative MRI and laparoscopy
Measured: at the time of surgery
Secondary outcomes (13)
Association of MRI findings by MEDL score with pain
Correlation coefficient between preoperative pain Visual Analog Scale (VAS) score and total MEDL score
Measured: preoperative
Association of MRI findings by MEDL score with infertility
Relationship between presence or absence of infertility and total MEDL score
Measured: preoperative
Association of MRI findings by MEDL score with SF-36
Relationship between responses to the SF-36 questionnaire and total MEDL score
Measured: preoperative
Association of MRI findings by MEDL score with Endometriosis Health Profile Questionnaire-30 (EHP-30)
Relationship between responses to the EHP-30 questionnaire and total MEDL score
Measured: preoperative
Association of MRI findings by MEDL score with postoperative recurrence
Relationship between presence or absence of postoperative recurrence
Measured: from surgery to obtaining informed consent, assessed up to 3 years (for retrospective data collection)
Association of MRI findings by MEDL score with Ultrasound-based Endometriosis Staging System (UBESS)
Relationship between stage of UBESS and total MEDL score
Measured: preoperative
Association of MRI findings by MEDL score with operating time
Relationship between hospital stay and total MEDL score
Measured: at the time of surgery
Association of MRI findings by MEDL score with hospital stay
Relationship between hospital stay and total MEDL score
Measured: at the time of surgery
Agreement rate among evaluators using the MEDL score
The agreement rate for each evaluation item of MEDL score when multiple evaluators evaluated
Measured: at the time of preoperative MR imaging
K coefficient among evaluators using the MEDL score
K coefficient for each evaluation item of MEDL score when multiple evaluators evaluated
Measured: at the time of preoperative MR imaging
Concordance between laparoscopic findings and transvaginal ultrasound findings using the MEDL score
Correlation coefficient of total MEDL score assessed by preoperative transvaginal ultrasound and laparoscopy
Measured: at the time of surgery
Association of MRI findings by MEDL score with rASRM score evaluated by laparoscopy
Correlation coefficient of total MEDL score assessed by preoperative MRI and rASRM score assessed by laparoscopy
Measured: at the time of surgery
Association of MRI findings by MEDL score with ENZIAN classification evaluated by laparoscopy and MRI
Association between total MEDL score assessed by preoperative MRI and ENZIAN classification assessed by laparoscopy
Measured: at the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start28 Jul 2021
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinica Medicina da Mulher
- Responsible party
- Sponsor
- Investigators
- Sponsor Chugai Pharmaceutical Co. Ltd, Study director, clinical-trials@chugai-pharm.co.jp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846582
- Sponsor's protocol ID
- AMY007BR
- Status last verified
- Sep 2023
- First submitted
- 18 Feb 2021
- Last updated
- 22 Sep 2023
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method for Evaluating Endometriosis Using MRI: A Study on the MEDL Score
- ClinicalTrials.gov ID
- NCT04846582
- Acronym / sponsor ID
- AMY007BR
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Clinica Medicina da Mulher
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 15 Apr 2021 (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.
The purpose of this study is to confirm the reproducibility that the MEDL score can be evaluated by Magnetic Resonance Imaging (MRI) in the similar way as laparoscopy, the gold standard for the evaluation of the disease state of endometriosis, in order to establish the MEDL score, a new evaluation index for endometriosis using MRI. Approximately 70-90 patients with endometriosis diagnosed by imaging and who are candidates for fertility-preserving surgery will be recruited retrospectively or prospectively, and the disease status of endometriosis will be evaluated using preoperative MR images, laparoscopic surgery videos, etc. The relationship between the condition and clinical symptoms, such as pain, is also considered.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with endometriosis diagnosed by imaging and who are candidates for fertility-preserving surgery
Key inclusion criteria (7 listed)
- Patients who consent to use their data in this study
- Patients with endometriosis diagnosed by transvaginal ultrasound (TVUS) and/or MRI
- Patients undergoing fertility-preserving surgery
- Patients with pain due to endometriosis
- Patients with endometriotic lesions other than ovarian cysts confirmed by MRI (concomitant ovarian cysts can be recruited)
Key exclusion criteria (3 listed)
- Patients who had surgery for endometriosis prior to the surgery included in this study
- Patients deemed inappropriate by the principal investigator
- Patients who obtained their voluntary consent but later withdrew their consent
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
Correlation of MEDL score assessed by MRI and laparoscopy
Time frame: at the time of surgery
Correlation coefficient of total MEDL score assessed by preoperative MRI and laparoscopy
13 secondary outcomes
Association of MRI findings by MEDL score with pain
Time frame: preoperative
Association of MRI findings by MEDL score with infertility
Time frame: preoperative
Association of MRI findings by MEDL score with SF-36
Time frame: preoperative
Association of MRI findings by MEDL score with Endometriosis Health Profile Questionnaire-30 (EHP-30)
Time frame: preoperative
Association of MRI findings by MEDL score with postoperative recurrence
Time frame: from surgery to obtaining informed consent, assessed up to 3 years (for retrospective data collection)
Association of MRI findings by MEDL score with Ultrasound-based Endometriosis Staging System (UBESS)
Time frame: preoperative
Association of MRI findings by MEDL score with operating time
Time frame: at the time of surgery
Association of MRI findings by MEDL score with hospital stay
Time frame: at the time of surgery
Agreement rate among evaluators using the MEDL score
Time frame: at the time of preoperative MR imaging
K coefficient among evaluators using the MEDL score
Time frame: at the time of preoperative MR imaging
Concordance between laparoscopic findings and transvaginal ultrasound findings using the MEDL score
Time frame: at the time of surgery
Association of MRI findings by MEDL score with rASRM score evaluated by laparoscopy
Time frame: at the time of surgery
Association of MRI findings by MEDL score with ENZIAN classification evaluated by laparoscopy and MRI
Time frame: at the time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).
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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.
Sponsor Chugai Pharmaceutical Co. Ltd study director
clinical-trials@chugai-pharm.co.jp
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 Chugai Pharmaceutical at 1 site in Brazil.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 22 Sep 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of MEDL score assessed by MRI and laparoscopy (time frame: at the time of surgery). 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 22 Sep 2023.