Validation of the Adenomyosis Calculator

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Brief Title

Validation of the Adenomyosis Calculator

Official Title

Prospective Validation of a Prediction Model for Diagnosing Adenomyosis With Ultrasound.

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.
    



Study Type

Observational


Primary Outcome

Diagnostic accuracy of the prediction model for adenomyosis

Secondary Outcome

 Intraclass correlation coefficient (ICC) between readers

Condition

Adenomyosis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

500

Start Date

January 2, 2020

Completion Date

December 2022

Primary Completion Date

June 2021

Eligibility 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
      

Gender

Female

Ages

N/A - 52 Years

Accepts Healthy Volunteers

No

Contacts

Marit Lieng, Phd, +4797793704, [email protected]

Location Countries

Finland

Location Countries

Finland

Administrative Informations


NCT ID

NCT04135118

Organization ID

OUS P360


Responsible Party

Principal Investigator

Study Sponsor

Oslo University Hospital

Collaborators

 The Hospital of Vestfold

Study Sponsor

Marit Lieng, Phd, Principal Investigator, Oslo University Hospital, Oslo, Norway


Verification Date

February 2020