AdenomyosisNCT06795711
Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis
An observational study of Adenomyosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Defining ultrasound criteria for normal uterine biometry and assessing the prevalence of repeat abortions in patients with abnormalities of the uterine cavity Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Adenomyosis
- How many people
- 465 participants
- Where
- 1 siteItaly
- Study dates
- 4 Apr 2022to 31 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients consecutively attending our ultrasound clinics for routine check-ups or pre-operative examinations will be included, as per regular practice. For the purposes of the analysis, patients will be divided into three groups according to the ultrasound and/or surgical diagnosis of A adenomyosis (presence of at least 2 ultrasound signs compatible with adenomyosis (MUSA) or presence of glands and endometrial stroma in myometrial location), B fibromatosis (uterus with inhomogeneous echostructure lacking 2 or more signs compatible with uterine adenomyosis or histological finding of several benign tumours consisting of smooth muscle tissue and fibrous tissue in varying proportions), C normal uterus (normal echostructure on transvaginal ultrasound)
Who may be able to join
- age between 18 and 60;
- obtaining informed consent
Who cannot join
- Hysterectomised patients;
- Virgo patients (hymenal integrity);
- Patients reporting intolerance to transvaginal ultrasound;
- Gynaecological oncology;
- Recent pregnancy or childbirth (within 6 months);
- Menopausal patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Diego Raimondo, MD, +393290636618, die.raimondo@gmail.com
Diego Raimondo, MD
About this study
Official title: Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis: a Prospective Observational Study
Defining ultrasound criteria for normal uterine biometry and assessing the prevalence of repeat abortions in patients with abnormalities of the uterine cavity
Read the detailed description
Adenomyosis is a gynaecological disorder with a high prevalence in women of childbearing age and is characterised by the presence of glands and endometrial stroma within the myometrium, associated or not with hypertrophy and hyperplasia of the surrounding myometrium. Adenomyosis may cause pelvic pain and/or abnormal uterine bleeding. Transvaginal ultrasound may be considered the main non-invasive diagnostic modality for the diagnosis of adenomyosis. The aim is to optimise the ultrasound diagnosis of uterine pathology and in particular of adenomyosis by defining uterine biometric parameters (longitudinal, transverse and anteroposterior diameters and their ratios; uterine volume) allowing patients to be divided into 3 groups:
- Uterus affected by adenomyosis (group A): adenomyosis is a gynaecological condition with high prevalence in women of childbearing age and is characterised by the presence of endometrial tissue (innermost layer of the uterus) within the uterine muscle. Adenomyosis can cause abdominal pain and abnormal uterine bleeding.
- Uterus affected by fibromatosis (group B): uterine fibromatosis is a gynaecological condition characterised by the appearance of numerous fibroids in the uterus. It is a very frequent condition in the general population and its frequency increases as the age of the patients increases.
- Normal uterus (group C). Transvaginal ultrasound, although a reference diagnostic tool, still remains an operator-dependent examination to date: our secondary objective is to build models that can simplify diagnosis through the use of artificial intelligence. The aim is to create various artificial intelligence software that can 'learn to make a diagnosis'. This method has already been applied in radiology, proving capable of discriminating between benign and malignant tumours from images from different diagnostic methods with performance similar to that of experienced radiologists.
- Conditions
- Adenomyosis
- Keywords
- adenomyosis, gynaecology, ultrasound
- Medical subject headings
- Adenomyosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Definition of uterine biometric parameters
Definition of uterine biometric parameters for the diagnosis of adenomyotic uterus (group A), fibromatous uterus (group B) and normal uterus (group C) by means of transvaginal ultrasound, performed as per the care procedure. Evaluation of the diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis as an additional parameter to those already known in the literature with possible subsequent identification of a biometric cut-off
Measured: After enrollment on first visit
Diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis
Evaluation of the diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis as an additional parameter to those already known in the literature with possible subsequent identification of a biometric cut-off
Measured: After enrollment on first visit
Secondary outcomes (4)
Construction of deep learning models on uterine ultrasound images
Construction of deep learning models trained, validated and tested on uterine ultrasound images for the ultrasound diagnosis of adenomyosis and evaluation of their diagnostic accuracy
Measured: After enrollment on first visit
Evaluation of diagnostic accuracy of deep learning validated
Evaluation of diagnostic accuracy of deep learning validated for ultrasound diagnosis of adenomyosis
Measured: After enrollment on first visit
Identification of the frequency of finding ultrasound signs of adenomyosis in the cervix
In patients with a diagnosis of adenomyosis made on the basis of ultrasound features at the level of the uterine body and fundus
Measured: After enrollment on first visit
Evaluation of diagnostic accuracy
Evaluation of the diagnostic accuracy of trainees when experienced (identifying experienced operators as doctors in specialised training in Gynaecology and Obstetrics for at least four years, with an experience of at least 500 gynaecological ultrasound cases) and moderately experienced (identifying moderately experienced operators as doctors in specialised training in Gynaecology and Obstetrics for at least two years, with an experience of at least 200 gynaecological ultrasound cases
Measured: After enrollment on first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start4 Apr 2022
- Primary completion31 Dec 2024
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 465 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego Raimondo, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795711
- Sponsor's protocol ID
- ADENAS
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06795711
- Acronym / sponsor ID
- ADENAS
- Conditions
- Adenomyosis
- Keywords
- adenomyosis, gynaecology, ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 465 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 28 Jan 2025 (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.
Defining ultrasound criteria for normal uterine biometry and assessing the prevalence of repeat abortions in patients with abnormalities of the uterine cavity
Detailed description
Adenomyosis is a gynaecological disorder with a high prevalence in women of childbearing age and is characterised by the presence of glands and endometrial stroma within the myometrium, associated or not with hypertrophy and hyperplasia of the surrounding myometrium. Adenomyosis may cause pelvic pain and/or abnormal uterine bleeding. Transvaginal ultrasound may be considered the main non-invasive diagnostic modality for the diagnosis of adenomyosis. The aim is to optimise the ultrasound diagnosis of uterine pathology and in particular of adenomyosis by defining uterine biometric parameters (longitudinal, transverse and anteroposterior diameters and their ratios; uterine volume) allowing patients to be divided into 3 groups:
- Uterus affected by adenomyosis (group A): adenomyosis is a gynaecological condition with high prevalence in women of childbearing age and is characterised by the presence of endometrial tissue (innermost layer of the uterus) within the uterine muscle. Adenomyosis can cause abdominal pain and abnormal uterine bleeding.
- Uterus affected by fibromatosis (group B): uterine fibromatosis is a gynaecological condition characterised by the appearance of numerous fibroids in the uterus. It is a very frequent condition in the general population and its frequency increases as the age of the patients increases.
- Normal uterus (group C). Transvaginal ultrasound, although a reference diagnostic tool, still remains an operator-dependent examination to date: our secondary objective is to build models that can simplify diagnosis through the use of artificial intelligence. The aim is to create various artificial intelligence software that can 'learn to make a diagnosis'. This method has already been applied in radiology, proving capable of discriminating between benign and malignant tumours from images from different diagnostic methods with performance similar to that of experienced radiologists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients consecutively attending our ultrasound clinics for routine check-ups or pre-operative examinations will be included, as per regular practice. For the purposes of the analysis, patients will be divided into three groups according to the ultrasound and/or surgical diagnosis of A adenomyosis (presence of at least 2 ultrasound signs compatible with adenomyosis (MUSA) or presence of glands and endometrial stroma in myometrial location), B fibromatosis (uterus with inhomogeneous echostructure lacking 2 or more signs compatible with uterine adenomyosis or histological finding of several benign tumours consisting of smooth muscle tissue and fibrous tissue in varying proportions), C normal uterus (normal echostructure on transvaginal ultrasound)
Key inclusion criteria (2 listed)
- age between 18 and 60;
- obtaining informed consent
Key exclusion criteria (6 listed)
- Hysterectomised patients;
- Virgo patients (hymenal integrity);
- Patients reporting intolerance to transvaginal ultrasound;
- Gynaecological oncology;
- Recent pregnancy or childbirth (within 6 months);
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
Definition of uterine biometric parameters
Time frame: After enrollment on first visit
Definition of uterine biometric parameters for the diagnosis of adenomyotic uterus (group A), fibromatous uterus (group B) and normal uterus (group C) by means of transvaginal ultrasound, performed as per the care procedure. Evaluation of the diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis as an additional parameter to those already known in the literature with possible subsequent identification of a biometric cut-off
Diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis
Time frame: After enrollment on first visit
Evaluation of the diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis as an additional parameter to those already known in the literature with possible subsequent identification of a biometric cut-off
4 secondary outcomes
Construction of deep learning models on uterine ultrasound images
Time frame: After enrollment on first visit
Evaluation of diagnostic accuracy of deep learning validated
Time frame: After enrollment on first visit
Identification of the frequency of finding ultrasound signs of adenomyosis in the cervix
Time frame: After enrollment on first visit
Evaluation of diagnostic accuracy
Time frame: After enrollment on first visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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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.
Diego Raimondo, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Adenomyosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diego Raimondo, MD (+393290636618, die.raimondo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definition of uterine biometric parameters (time frame: After enrollment on first visit). The study lists 2 primary outcomes in all. 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 28 Jan 2025.