Evaluating ovarian masses in young patients
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
This study is testing new ways to better understand and manage ovarian masses in young patients aged 20 and under to improve their care and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 0 Years to 20 Years |
| Sex | Female |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06693596 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study focuses on validating the IOTA Simple Rules, Benign Descriptors, and ADNEX model specifically for patients aged 20 and under with newly diagnosed adnexal masses. The study aims to assess the diagnostic accuracy of ultrasound evaluations and analyze the rate of complications associated with conservative management. Given the rarity of ovarian masses in this age group, the research seeks to provide comprehensive data to improve management strategies and outcomes for young patients. By addressing the variability in current practices, this study aims to enhance the understanding of benign versus malignant lesions in pediatric populations.
Who should consider this trial
Good fit: Ideal candidates for this study are girls and adolescents aged 20 or under who have newly diagnosed adnexal masses.
Not a fit: Patients with non-adnexal masses or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and management strategies for young patients with ovarian masses.
How similar studies have performed: While there is limited data on similar approaches in this specific population, existing models have shown promise in adult populations, indicating potential for success in younger patients.
Eligibility criteria
Show full inclusion / exclusion 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) 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
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Dirk Timmerman, Prof.
- Email: iota@uzleuven.be
- Phone: +3216344202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.