Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adnexal Cyst | — | UNRESOLVED | — |
| Adnexal Mass | — | UNRESOLVED | — |
| Adnexal Masses in Young Girls and Adolescents | — | UNRESOLVED | — |
| Adnexal Tumor | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group 1: Surgical management | Procedure | — | UNRESOLVED |
| Group 2: Conservative management (follow-up) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1: Surgical management
- description
- Patients aged ≤ 20 years of age recommended for surgery at that visit due to a suspicion of malignancy or pain.
- interventionNames
- Procedure: Group 1: Surgical management
- label
- Group 2: Conservative management (follow-up)
- description
- Patients aged ≤ 20 not recommended for surgery due to suspicion of malignancy/complications, for which subjective impression was benign for all visits, and for which the tumour was still present at the next visit.
- interventionNames
- Diagnostic Test: Group 2: Conservative management (follow-up)
Primary outcomes (5)
- measure
- Estimation of the ability of the ADNEX model without CA125 to discriminate between benign and malignant adnexal masses when detected in patients aged 20 or under (AUC)
- timeFrame
- Outcome based on histology for group 1 assessed at 12 months after recruitment or no sign of malignancy during the ultrasound follow-up for group 2 assessed up to 12 months after recruitment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 0 Years
- Maximum age
- 20 Years
Show eligibility criteria text
• 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
References
Publications (0)
Data not yet available