AdenomyosisNCT04135118
Validation of the Adenomyosis Calculator
An observational study of Adenomyosis and Pelvic Pain Syndrome, run by Oslo University Hospital at 5 sites in 2 countries.
Trial summary
Adenomyosis is a disease where ectopic endometrial glands affect the muscular wall of the uterus. Women that suffer from dysmenorrhea or infertility caused by adenomyosis need to confirm or rule out adenomyosis, and therefore tools for non-histologic confirmation of adenomyosis are indubitably required. Read more about this study
- Who is it for?
- Ages Up to 52 years, women only
- Conditions the study is for
- Adenomyosis, Pelvic Pain Syndrome
- How many people
- 500 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 2 Jan 2020to 1 Sep 2022
- 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 Up to 52 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: A consecutive sample of women that are scheduled for a hysterectomy at one of the study sites and fulfill eligibility criteria are invited to participate.
Who may be able to join
- Premenopausal (defined by having had menstruation the last six month)
- If amenorrhea with levonorgestrel intrauterine device, the woman should be < 45 years old
- Hysterectomy planned due to a benign condition
- Hysterectomy does not require morcellation it is allowed to divide the uterus into 2-3 pieces, given that the orientation of the specimen is still possible for the pathologist)
- Written consent is given
- Can communicate in Norwegian or English at the Norwegian study sites, and Finnish, Swedish or English at the Finnish study site.
Who cannot join
- Gynecological cancer present at the time of inclusion
- Use of gonadotropin-releasing hormone agonist or antagonist within the last 3 months prior to the ultrasound evaluation
- Prior endometrial ablation or resection
- Postmenopausal status or no menstrual bleeding for the last 6 months, or amenorrhea with levonorgestrel-intrauterine device and age >45 years.
- Need for morcellation of the uterus
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Norway4 sites
Akershus University Hospital, Dept. of gynecology
Lørenskog, Akershus, 1478
Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital
Oslo, 0382
Sykehuset i Vestfold
Tønsberg, Vestfold, 3103
St. Olavs Hospital, Dept. of Gynecology
Trondheim, Trøndelag, NO-7006
About this study
Official title: Prospective Validation of a Prediction Model for Diagnosing Adenomyosis With Ultrasound.
Adenomyosis is a disease where ectopic endometrial glands affect the muscular wall of the uterus. Women that suffer from dysmenorrhea or infertility caused by adenomyosis need to confirm or rule out adenomyosis, and therefore tools for non-histologic confirmation of adenomyosis are indubitably required. Transvaginal ultrasound has been shown to be useful in diagnosing adenomyosis, but the interpretation of findings requires significant expertise in ultrasound and experience with diagnosing adenomyosis. This is because adenomyosis shows a very heterogeneous appearance in ultrasound. There are many different diagnostic signs that have to be considered and weighed.
In a previous study, the investigators have developed a diagnostic algorithm that helps clinicians diagnose adenomyosis with transvaginal ultrasound and a clinical examination. It showed good diagnostic accuracy and seemed to be very robust with regards to artifacts and experience of the examiner. It is now necessary to validate this prediction model in a new, prospective study so it can be used in clinical practice.
- Conditions
- Adenomyosis, Pelvic Pain Syndrome
- Medical subject headings
- Adenomyosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the prediction model for adenomyosis
Diagnostic accuracy will be described using sensitivity (in %), specificity (in %), positive predictive value (in %), negative predictive value (in %), positive likelihood ratio (calculated by sensitivity/1-specificity), negative likelihood ratio (calculated as 1-sensitivity/specificity) and the area under the receiver-operator curve (as calculated with the (0-1) of the model.
Measured: 1 year
Secondary outcomes (1)
Intraclass correlation coefficient (ICC) between readers
ICC values are categorized as follows: 0-0.20, slight agreement; 0.21-0.40, fair agreement; 0.41-0.60, moderate agreement; 0.61-0.80, substantial agreement; and 0.81-1, almost perfect agreement
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 posted22 Oct 2019
- Study start2 Jan 2020
- Primary completion23 Jun 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Oslo University 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital of Vestfold, University Hospital, Akershus, St. Olavs Hospital, Turku University Hospital
- Responsible party
- Principal investigator, Marit Lieng, Oslo University Hospital
- Investigators
- Marit Lieng, Phd, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135118
- Sponsor's protocol ID
- OUS P360
- Status last verified
- Dec 2023
- First submitted
- 16 Oct 2019
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the values of all evaluated predictors in the model so that they can be used for re-calculation.
Publications
Tellum T, Nygaard S, Skovholt EK, Qvigstad E, Lieng M. Development of a clinical prediction model for diagnosing adenomyosis. Fertil Steril. 2018 Oct;110(5):957-964.e3. doi: 10.1016/j.fertnstert.2018.06.009.
PubMed 30316443
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of a Prediction Model for Diagnosing Adenomyosis With Ultrasound.
- ClinicalTrials.gov ID
- NCT04135118
- Acronym / sponsor ID
- OUS P360
- Conditions
- Adenomyosis, Pelvic Pain Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Hospital of Vestfold, University Hospital, Akershus, St. Olavs Hospital, Turku University Hospital
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 22 Oct 2019 (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.
Adenomyosis is a disease where ectopic endometrial glands affect the muscular wall of the uterus. Women that suffer from dysmenorrhea or infertility caused by adenomyosis need to confirm or rule out adenomyosis, and therefore tools for non-histologic confirmation of adenomyosis are indubitably required. Transvaginal ultrasound has been shown to be useful in diagnosing adenomyosis, but the interpretation of findings requires significant expertise in ultrasound and experience with diagnosing adenomyosis. This is because adenomyosis shows a very heterogeneous appearance in ultrasound. There are many different diagnostic signs that have to be considered and weighed.
In a previous study, the investigators have developed a diagnostic algorithm that helps clinicians diagnose adenomyosis with transvaginal ultrasound and a clinical examination. It showed good diagnostic accuracy and seemed to be very robust with regards to artifacts and experience of the examiner. It is now necessary to validate this prediction model in a new, prospective study so it can be used in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A consecutive sample of women that are scheduled for a hysterectomy at one of the study sites and fulfill eligibility criteria are invited to participate.
Key inclusion criteria (6 listed)
- Premenopausal (defined by having had menstruation the last six month)
- If amenorrhea with levonorgestrel intrauterine device, the woman should be < 45 years old
- Hysterectomy planned due to a benign condition
- Hysterectomy does not require morcellation it is allowed to divide the uterus into 2-3 pieces, given that the orientation of the specimen is still possible for the pathologist)
- Written consent is given
Key exclusion criteria (5 listed)
- Gynecological cancer present at the time of inclusion
- Use of gonadotropin-releasing hormone agonist or antagonist within the last 3 months prior to the ultrasound evaluation
- Prior endometrial ablation or resection
- Postmenopausal status or no menstrual bleeding for the last 6 months, or amenorrhea with levonorgestrel-intrauterine device and age >45 years.
- Need for morcellation of the uterus
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
Diagnostic accuracy of the prediction model for adenomyosis
Time frame: 1 year
Diagnostic accuracy will be described using sensitivity (in %), specificity (in %), positive predictive value (in %), negative predictive value (in %), positive likelihood ratio (calculated by sensitivity/1-specificity), negative likelihood ratio (calculated as 1-sensitivity/specificity) and the area under the receiver-operator curve (as calculated with the (0-1) of the model.
1 secondary outcome
Intraclass correlation coefficient (ICC) between readers
Time frame: 2 years
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 27 Dec 2023.
- Background: PubMed 30316443Tellum T, Nygaard S, Skovholt EK, Qvigstad E, Lieng M. Development of a clinical prediction model for diagnosing adenomyosis. Fertil Steril. 2018 Oct;110(5):957-964.e3. doi: 10.1016/j.fertnstert.2018.06.009.
- Individual participant dataSharing planned: Yes. We will share the values of all evaluated predictors in the model so that they can be used for re-calculation.
Related trials for Adenomyosis
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Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
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Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
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RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
Stellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery
Uterine Fibroids (Leiomyoma), Adenomyosis of Uterus
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.
Marit Lieng, Phd principal investigator
Oslo University Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis and Pelvic Pain Syndrome, run by Oslo University Hospital at 5 sites in 2 countries.
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 6 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: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway, Finland. 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?
Diagnostic accuracy of the prediction model for adenomyosis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04135118, which also lists 1 linked publication.
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 27 Dec 2023.