Validation of the ADNEX Model for identifying ovarian masses during pregnancy
Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy: the International Ovarian Tumour Analysis in Pregnancy Study (p-IOTA).
This study is testing a new ultrasound tool to help doctors tell the difference between harmless and harmful ovarian masses in pregnant women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT05974618 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the ADNEX Model, an ultrasound-based tool, for distinguishing between benign and malignant adnexal masses in pregnant women. It involves a multicenter, prospective cohort design where patients with non-physiological adnexal masses or physiological cysts measuring 5 cm or more will be assessed. The study will utilize a two-step strategy, first applying the Modified Benign Simple Descriptors followed by the ADNEX Model to improve diagnostic accuracy. The primary outcome will focus on the false discovery rate of benign masses classified as malignant.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older with adnexal masses or cysts measuring 5 cm or more.
Not a fit: Patients with clearly physiological cysts smaller than 5 cm or those with non-adnexal masses will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing adnexal masses in pregnancy, potentially reducing unnecessary surgical interventions.
How similar studies have performed: Previous studies have validated the ADNEX Model in non-pregnant women, but its application in pregnant populations is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Consecutive patients with non-physiological adnexal masses or physiological cysts measuring 5cm or more in largest dimension; * In case of more than one mass seen, only most suspicious mass to be included OR in case of two similar masses, the one with the largest dimension or most easily accessible with ultrasound; * Previously recruited patient presenting with a different mass in subsequent pregnancy; * Age 18 years and above. Exclusion Criteria: * • Cysts deemed to be clearly physiological WHEN smaller than 5 cm (largest diameter); * Non-adnexal masses, e.g. peritoneal inclusion cysts (when diagnosis is certain) and peritoneal carcinomatosis with no adnexal mass; * The denial or withdrawal of written informed consent; * Same cyst already recruited for p-IOTA in a previous pregnancy. * Age \< 18 years
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Study coordinator: Dirk Timmerman, Professor
- Email: dirk.timmerman@uzleuven.be
- Phone: +3216344201
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.