Masses in Young Patients - International Ovarian Tumour Analysis (MY-IOTA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age0-20
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
This multicenter observational study aims to validate the IOTA Simple Rules, Benign Descriptors, and ADNEX model in a cohort of patients equal or under the age of 20. Moreover, the study aims to evaluate the diagnostic accuracy of subjective assessment by ultrasound and to analyze the rate of complications in patients treated conservatively.
Eligibility criteria
Qualifiers
None
Disqualifiers
Non-adnexal masses e.g. peritoneal inclusion cysts (where diagnosis is certain) and peritoneal carcinomatosis with no adnexal mass;
The denial or withdrawal of written informed consent.
Pregnancy at any timepoint during the study period
In premenarchal participants: follicle measuring <10mm
Trial design
Treatments tested in this trial
- Group 2: Conservative management (follow-up)
- Group 1: Surgical management
Treatment groups
1,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov