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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)
RECRUITINGSponsored by Universitaire Ziekenhuizen KU Leuven
Actively Recruiting
SponsorUniversitaire Ziekenhuizen KU Leuven
Started2023-06-05
Est. completion2026-07
Eligibility
Age18 Years – 50 Years
SexFEMALE
View on ClinicalTrials.gov →
NCT05974618
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)
Eligibility
Age: 18 Years – 50 YearsSex: FEMALE
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
Conditions5
Adnexal CystAdnexal MassAdnexal TumorCancerPregnancy Related
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Actively Recruiting
SponsorUniversitaire Ziekenhuizen KU Leuven
Started2023-06-05
Est. completion2026-07
Eligibility
Age18 Years – 50 Years
SexFEMALE
View on ClinicalTrials.gov →
NCT05974618