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

RecruitingOBSERVATIONAL
Enrollment

1,000

Participants

Timeline

Start Date

November 20, 2024

Primary Completion Date

July 21, 2026

Study Completion Date

September 30, 2026

Conditions
Adnexal MassAdnexal TumorAdnexal CystAdnexal Masses in Young Girls and Adolescents
Interventions
DIAGNOSTIC_TEST

Group 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)"

PROCEDURE

Group 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."

Trial Locations (1)

3000

RECRUITING

UZ Leuven, Leuven

All Listed Sponsors
lead

Universitaire Ziekenhuizen KU Leuven

OTHER