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Masses in Young Patients - International Ovarian Tumour Analysis (MY-IOTA)

RECRUITINGSponsored by Universitaire Ziekenhuizen KU Leuven
Actively Recruiting
SponsorUniversitaire Ziekenhuizen KU Leuven
Started2024-11-20
Est. completion2026-07-21
Eligibility
Age0 Years – 20 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06693596

Summary

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

Age: 0 Years – 20 YearsSex: FEMALEHealthy volunteers accepted
• Inclusion Criteria:

All newly diagnosed adnexal masses identified in a girl or adolescent aged 20 or under.

• Exclusion Criteria:

Participants eligible for this study must not meet any of the following criteria:

* 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

Conditions5

Adnexal CystAdnexal MassAdnexal Masses in Young Girls and AdolescentsAdnexal TumorCancer

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