RecruitingNCT05974618

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)

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).


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

1,000 participants

Start Date

Jun 5, 2023

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a tool called the ADNEX model to better predict whether an ovarian cyst or mass found during pregnancy is cancerous or harmless. **You may be eligible if...** - You are pregnant and have been found to have an ovarian cyst or other mass near your ovary - The cyst or mass is 5 cm (about 2 inches) or larger - You are 18 years of age or older **You may NOT be eligible if...** - Your cyst is smaller than 5 cm and appears to be a normal pregnancy-related cyst - Your mass is not located near the ovary (e.g., it is a cyst on the outer lining of the abdomen) - You have already been enrolled in this study for the same cyst in a previous pregnancy - You are under 18 years of age Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTUltrasound

A standardised transvaginal (supplemented with transabdominal if transvaginal is not sufficient) examination is performed. When a colour Doppler ultrasound examination is performed, the pulse repetition frequency should be 0.3-0.6 KHz. The colour Doppler gain should be increased until colour Doppler artefacts appear and then lowered until just below the reappearance of colour Doppler artefacts. Ultrasound frequency and "priority" (grey scale or colour/Power Doppler) must also be optimised when using colour/power Doppler. Doppler ultrasound should be used with all masses included, irrespective of gestational age.


Locations(1)

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

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NCT05974618


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