RecruitingNCT06693596

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

Masses in Young Patients - International Ovarian Tumour Analysis: Prospective Validation and Comparison of Simple Rules, Benign Descriptors and ADNEX Models for Discrimination Between Benign and Malignant Adnexal Masses in Young Girls and Adolescents MY-IOTA

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

1,000 participants

Start Date

Nov 20, 2024

Study Type

OBSERVATIONAL

Conditions

Adnexal Cyst Adnexal Mass Adnexal Tumor Adnexal Masses in Young Girls and Adolescents

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

Sex: FEMALEMin Age: 0 YearsMax Age: 20 Years

Inclusion Criteria1

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

Exclusion Criteria5

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

Interventions

DIAGNOSTIC_TESTGroup 2: Conservative management (follow-up)

A standardised transabdominal examination is performed, including color or power Doppler examination. Transvaginal ultrasonography can be performed in sexually active adolescents with consent. Transrectal examination is also acceptable for younger patients who are not sexually active. All the variables required for the Simple Rules, simple descriptors and ADNEX model are assessed. Before entering ultrasound information about the tumour and getting model results, the ultrasound examiner' s diagnosis (benign, borderline, malignant; specific diagnosis) based on subjective assessment is recorded. Results based on Simple Rules, simple descriptors and ADNEX model are documented as well. If the adnexal mass is seen and if the decision is to manage the adnexal mass conservatively, the patient will be re-scanned at 6 weeks (maximal range 6-8 weeks), 3 months (+/- 2 weeks) and 12 months (maximal range 10-14 months)

PROCEDUREGroup 1: Surgical management

A standardised transabdominal examination is performed, including color or power Doppler examination. Transvaginal ultrasonography can be performed in sexually active adolescents with consent. Transrectal examination is also acceptable for younger patients who are not sexually active. All the variables required for the Simple Rules, simple descriptors and ADNEX model are assessed. Before entering ultrasound information about the tumour and getting model results, the ultrasound examiner' s diagnosis (benign, borderline, malignant; specific diagnosis) based on subjective assessment is recorded. Results based on Simple Rules, simple descriptors and ADNEX model are documented as well. If the patient requires surgery, no further ultrasound scans will be required.