Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy: International Ovarian Tumour Analysis in Pregnancy Study (p-IOTA)

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jul 25, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy" is designed to improve how doctors identify whether certain growths on the ovaries (called adnexal masses) during pregnancy are harmless or potentially harmful. This trial is specifically looking at women who are pregnant and have adnexal masses or cysts that are 5 centimeters or larger. If you are a woman aged 18 or older and have been diagnosed with one of these masses, you may be eligible to participate.

If you join this study, you will undergo tests and evaluations to help researchers better understand how to distinguish between non-dangerous and dangerous masses using a special model called the ADNEX model. The study is currently recruiting participants, and it’s important to note that if you choose to participate, your health and safety will be closely monitored throughout the process. This research aims to provide clearer answers for pregnant women facing similar concerns, ultimately leading to better care and outcomes for both mothers and their babies.

Gender

FEMALE

Eligibility 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