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

Plain Language Summary

Simplified for easier understanding

This international study is collecting data on ovarian and pelvic masses found in girls and young women aged 20 and under, to improve how doctors classify and manage these lesions. Many masses in young patients are benign cysts, and better data could help avoid unnecessary surgery. **You may be eligible if...** - You are 20 years old or younger - You have a newly diagnosed mass in the ovary or nearby pelvic structures (called an adnexal mass) **You may NOT be eligible if...** - The mass is clearly not in the ovary or adnexa (for example, a fluid collection caused by another organ) - You or your guardian do not consent to participation - You are currently pregnant or become pregnant during the study - You are premenarchal (have not yet started your period) and the finding is only a small follicle less than 10mm Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.