Validation of the Adenomyosis Calculator

NCT04135118 | Completed DMC

• 1 other identifier: OUS P360
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 5

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.

Conditions

Adenomyosis; Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Intraclass correlation coefficient (ICC) between readers

  2 years

Eligibility Criteria

• Age: Up to 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• The Hospital of Vestfold: collaborator
• University Hospital, Akershus: collaborator
• St. Olavs Hospital: collaborator
• Turku University Hospital: collaborator

Study Sites (5)

Turku University Hospital

Turku, 20521, Finland

Location

Akershus University Hospital, Dept. of gynecology

Lørenskog, Akershus, 1478, Norway

Location

St. Olavs Hospital, Dept. of Gynecology

Trondheim, Trøndelag, NO-7006, Norway

Location

Sykehuset i Vestfold

Tønsberg, Vestfold, 3103, Norway

Location

Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital

Oslo, 0382, Norway

Location

Related Publications (1)

• 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.

  PMID: 30316443 BACKGROUND

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Marit Lieng, Phd

  Oslo University Hospital, Oslo, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department, dept. of gynecology, Oslo University Hospital

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 22, 2019
• Study Start: January 2, 2020
• Primary Completion: June 23, 2022
• Study Completion: September 1, 2022
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

NO (4); FI (1)