Masses in Young Patients - International Ovarian Tumour Analysis (MY-IOTA)
Recruiting
Observational Study
Adnexal Mass
Adnexal Tumor
Adnexal Cyst
Adnexal Masses in Young Girls and Adolescents
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 0 – 20
- Sex
- Female
- Study type
- Observational
- Participants needed
- 1,000 (estimated)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Other
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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.
Trial Locations
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Eligibility Criteria
• 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) …
Contacts