Status:
RECRUITING
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)
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Adnexal Mass
Adnexal Tumor
Eligibility:
FEMALE
18-50 years
Brief Summary
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)
Detailed Description
1\. STUDY SUMMARY TITLE Prospective Validation of the ADNEX Model for discrimination between benign and malignant adnexal masses in pregnancy: the International Ovarian Tumour Analysis in pregnancy s...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
June 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05974618
Start Date
June 5 2023
End Date
July 1 2026
Last Update
August 3 2023
Active Locations (1)
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1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000