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Validation of the Adenomyosis Calculator

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ClinicalTrials.gov Identifier: NCT04135118
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
The Hospital of Vestfold
University Hospital, Akershus
St. Olavs Hospital
Turku University Hospital
Information provided by (Responsible Party):
Marit Lieng, Oslo University Hospital

Study Description
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Brief 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. 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.


Condition or disease
Adenomyosis Pelvic Pain Syndrome

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Validation of a Prediction Model for Diagnosing Adenomyosis With Ultrasound.
Actual Study Start Date : January 2, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Intraclass correlation coefficient (ICC) between readers [ Time Frame: 2 years ]
    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


Eligibility Criteria
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Ages Eligible for Study:   up to 52 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135118


Contacts
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Contact: Tina Tellum, MD +4797793704 tina.tellum@gmail.com

Locations
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Finland
Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Antti Perheentupa, Phd         
Norway
Akershus University Hospital, Dept. of gynecology Recruiting
Lørenskog, Akershus, Norway, 1478
Contact: Jette Stær-Jensen, Phd         
St. Olavs Hospital, Dept. of Gynecology Recruiting
Trondheim, Trøndelag, Norway, NO-7006
Contact: Ingrid M Ringen, MD         
Sykehuset i Vestfold Recruiting
Tønsberg, Vestfold, Norway, 3103
Contact: Siri Skrøppa, MD         
Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital Recruiting
Oslo, Norway, 0382
Contact: Tina Tellum, MD    +4797793704    tina.tellum@gmail.com   
Contact: Tone Walstad       uxtowa@ous-hf.no   
Principal Investigator: Tina Tellum, MD         
Sponsors and Collaborators
Oslo University Hospital
The Hospital of Vestfold
University Hospital, Akershus
St. Olavs Hospital
Turku University Hospital
Investigators
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Principal Investigator: Marit Lieng, Phd Oslo University Hospital, Oslo, Norway
More Information
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Publications:

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Responsible Party: Marit Lieng, Head of department, dept. of gynecology, Oslo University Hospital, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04135118    
Other Study ID Numbers: OUS P360
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share the values of all evaluated predictors in the model so that they can be used for re-calculation.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: The data is planned to be made available within a year after the publication of all results.
Access Criteria: Access will be granted upon request and evaluation of the intended use of the data. The intended use should primarily gain improved patient care and research into adenomyosis and a detailed protocol has to be submitted.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenomyosis
Pelvic Pain
Pain
Neurologic Manifestations
Uterine Diseases