AdenomyosisNCT06223464
Evaluation of the Relationship Between Adenomyosis and Elastographic Properties of the Cervix
An observational study of Adenomyosis, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the potential of cervical elastography, a non-invasive method, in the accurate diagnosis and clinical course of adenomyosis. Cervical elastography is an imaging method that measures the elasticity properties of cervical tissue using ultrasound technology. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adenomyosis
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2023to 18 Apr 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study will be included in our study as two case groups with and without the diagnosis of adenomyosis, whose age is 18-45 reproductive period, pregnancy status is excluded, without cervical infection, pathology and anomaly, without systemic disease findings and diagnoses, without chronic drug use, whose gynecological examination was performed and evaluated by ultrasonographic imaging after the application to Etlik City Hospital Gynecology and Obstetrics Clinic. MUSA criteria will be used in the diagnosis of adenomyosis and elastography measurements in kPa will be performed similar to the studies in the literature examples section in the file.
Who may be able to join
- Female patients between 18-45 years of age who volunteered and consented to the reproductive period study
- Patients diagnosed with adenomyosis using MUSA criteria
Who cannot join
- Pregnancy status
- Pelvic/Cervical infection, pathology and anomalies
- History of cervical surgery
- Diagnosis and findings of systemic disease
- Chronic drug use
- Advanced maternal obesity preventing measurement
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06000
About this study
This study aims to evaluate the potential of cervical elastography, a non-invasive method, in the accurate diagnosis and clinical course of adenomyosis. Cervical elastography is an imaging method that measures the elasticity properties of cervical tissue using ultrasound technology. This method may be helpful in providing information about the development and clinical course of adenomyosis.
Read the detailed description
Adenomyosis is the proliferation of endometrial gland and stroma within the myometrium of the uterus. Its prevalence varies between 10% and 40% in epidemiologic data. It often causes painful menstruation, pelvic pain and other gynecologic symptoms. While adenomyosis may be mild in some patients, it may show infiltrative and severe invasion in others. Advanced cases may be resistant to medical treatment and may affect nearby organs, which makes surgical treatment quite complicated. Therefore, early diagnosis of the disease is important for clinical practice. Global enlargement of the uterus, dysmenorrhea (painful menstruation), menorrhagia, abnormal uterine bleeding and pelvic pain are considered typical clinical symptoms of adenomyosis. However, it should be kept in mind that these symptoms coincide with the histologic diagnosis in a very small proportion of cases, 22% to 65%. The diagnosis and treatment of adenomyosis is complex and therefore there is a need to develop better diagnostic tools and treatment strategies for the management of patients. In this context, new imaging modalities such as cervical elastography may be of potential importance.
Our main hypothesis is that cervical elastography values will be significantly higher in patients with adenomyosis compared to patients without adenomyosis. Our secondary hypothesis is that cervical elastography values will be related to the severity and process of adenomyosis and may be an indicator to predict the symptoms and complications of adenomyosis.
The advantages of Cervical Elastography are the following:
It is non-invasive: Cervical Elastography is performed using ultrasound technology and has no known harm. It stands as a potentially safe method compared to existing invasive tests.
Cost-effective and easy to perform: Cervical Elastography is a procedure performed using existing ultrasound equipment at no separate cost. Therefore, it can be easily performed and repeated in clinical settings.
Fast Results: Cervical Elastography provides fast results by acquiring images in real time. This indicates that cervical elastography can be a valuable diagnostic tool in emergency situations or when rapid decision-making is required.
A potential predictive tool: The results of this study may indicate that the value of cervical elastography is a potential tool for predicting adenomyosis. It may be an important step to develop early diagnosis and treatment strategies to improve health in patients with adenomyosis.
The aim of this study was to compare cervical elastography values between groups of patients with and without adenomyosis and to evaluate the potential of cervical elastography values (quantified in kPa) in the diagnosis of adenomyosis.
- Conditions
- Adenomyosis
- Keywords
- adenomyosis, elastography, cervical
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adenomyosis-Case Group | The study will include those diagnosed with adenomyosis who were evaluated by gynecological examination and ultrasonographic imaging after the application to Etlik City Hospital Gynecology and Obstetrics Clinic, aged 18-45 reproductive period, pregnancy status excluded, without cervical infection, pathology and anomaly, without systemic disease findings and diagnoses, without chronic drug use. | |
| Healthy patients-Control | The study will include those who have been gynecologically examined and evaluated with ultrasonographic imaging after the application to Etlik City Hospital Gynecology and Obstetrics Clinic, aged 18-45 reproductive period, pregnancy status excluded, without cervical infection, pathology and anomaly, without systemic disease findings and diagnoses, without chronic drug use, without adenomyosis diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Adenomyosis
MUSA Criteria
Measured: 2 months
Secondary outcomes (1)
Diagnosis of Adenomyosis-Cervical Elastography
Cervical Elastography
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start18 Oct 2023
- Primary completion18 Dec 2023
- Study completion18 Apr 2024 (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 Ankara Etlik City HospitalThe 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-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dilara SARIKAYA KURT, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223464
- Sponsor's protocol ID
- AESH-EK1-2023-630
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data is not open to access due to hospital policy. however, the principal investigator can be reached via e-mail if necessary
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Adenomyosis and Elastographic Properties of the Cervix
- ClinicalTrials.gov ID
- NCT06223464
- Acronym / sponsor ID
- AESH-EK1-2023-630
- Conditions
- Adenomyosis
- Keywords
- adenomyosis, elastography, cervical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Apr 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
This study aims to evaluate the potential of cervical elastography, a non-invasive method, in the accurate diagnosis and clinical course of adenomyosis. Cervical elastography is an imaging method that measures the elasticity properties of cervical tissue using ultrasound technology. This method may be helpful in providing information about the development and clinical course of adenomyosis.
Detailed description
Adenomyosis is the proliferation of endometrial gland and stroma within the myometrium of the uterus. Its prevalence varies between 10% and 40% in epidemiologic data. It often causes painful menstruation, pelvic pain and other gynecologic symptoms. While adenomyosis may be mild in some patients, it may show infiltrative and severe invasion in others. Advanced cases may be resistant to medical treatment and may affect nearby organs, which makes surgical treatment quite complicated. Therefore, early diagnosis of the disease is important for clinical practice. Global enlargement of the uterus, dysmenorrhea (painful menstruation), menorrhagia, abnormal uterine bleeding and pelvic pain are considered typical clinical symptoms of adenomyosis. However, it should be kept in mind that these symptoms coincide with the histologic diagnosis in a very small proportion of cases, 22% to 65%. The diagnosis and treatment of adenomyosis is complex and therefore there is a need to develop better diagnostic tools and treatment strategies for the management of patients. In this context, new imaging modalities such as cervical elastography may be of potential importance.
Our main hypothesis is that cervical elastography values will be significantly higher in patients with adenomyosis compared to patients without adenomyosis. Our secondary hypothesis is that cervical elastography values will be related to the severity and process of adenomyosis and may be an indicator to predict the symptoms and complications of adenomyosis.
The advantages of Cervical Elastography are the following:
It is non-invasive: Cervical Elastography is performed using ultrasound technology and has no known harm. It stands as a potentially safe method compared to existing invasive tests.
Cost-effective and easy to perform: Cervical Elastography is a procedure performed using existing ultrasound equipment at no separate cost. Therefore, it can be easily performed and repeated in clinical settings.
Fast Results: Cervical Elastography provides fast results by acquiring images in real time. This indicates that cervical elastography can be a valuable diagnostic tool in emergency situations or when rapid decision-making is required.
A potential predictive tool: The results of this study may indicate that the value of cervical elastography is a potential tool for predicting adenomyosis. It may be an important step to develop early diagnosis and treatment strategies to improve health in patients with adenomyosis.
The aim of this study was to compare cervical elastography values between groups of patients with and without adenomyosis and to evaluate the potential of cervical elastography values (quantified in kPa) in the diagnosis of adenomyosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenomyosis-Case Group | – | –The study will include those diagnosed with adenomyosis who were evaluated by gynecological examination and ultrasonographic imaging after the application to Etlik City Hospital Gynecology and Obstetrics Clinic, aged 18-45 reproductive period, pregnancy status excluded, without cervical infection, pathology and anomaly, without systemic disease findings and diagnoses, without chronic drug use. |
| Healthy patients-Control | – | –The study will include those who have been gynecologically examined and evaluated with ultrasonographic imaging after the application to Etlik City Hospital Gynecology and Obstetrics Clinic, aged 18-45 reproductive period, pregnancy status excluded, without cervical infection, pathology and anomaly, without systemic disease findings and diagnoses, without chronic drug use, without adenomyosis diagnosis. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will be included in our study as two case groups with and without the diagnosis of adenomyosis, whose age is 18-45 reproductive period, pregnancy status is excluded, without cervical infection, pathology and anomaly, without systemic disease findings and diagnoses, without chronic drug use, whose gynecological examination was performed and evaluated by ultrasonographic imaging after the application to Etlik City Hospital Gynecology and Obstetrics Clinic. MUSA criteria will be used in the diagnosis of adenomyosis and elastography measurements in kPa will be performed similar to the studies in the literature examples section in the file.
Key inclusion criteria (2 listed)
- Female patients between 18-45 years of age who volunteered and consented to the reproductive period study
- Patients diagnosed with adenomyosis using MUSA criteria
Key exclusion criteria (6 listed)
- Pregnancy status
- Pelvic/Cervical infection, pathology and anomalies
- History of cervical surgery
- Diagnosis and findings of systemic disease
- Chronic drug use
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
Diagnosis of Adenomyosis
Time frame: 2 months
MUSA Criteria
1 secondary outcome
Diagnosis of Adenomyosis-Cervical Elastography
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No. Patient data is not open to access due to hospital policy. however, the principal investigator can be reached via e-mail if necessary
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 25 Jan 2024. 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 Turkey (Türkiye). 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?
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?
Diagnosis of Adenomyosis (time frame: 2 months). 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 25 Jan 2024.