NCT05974618 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)
| NCT ID | NCT05974618 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Adnexal Mass |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-06-05 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2023-06-05 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05974618 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Adnexal Mass. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05974618 currently recruiting?
Yes, NCT05974618 is actively recruiting participants. Contact the research team at dirk.timmerman@uzleuven.be for enrollment information.
Where is the NCT05974618 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT05974618 clinical trial?
NCT05974618 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 1,000 participants.