Actively 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)
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2023-08-03
1000
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consecutive patients with non-physiological adnexal masses or physiological cysts measuring 5cm or more in largest dimension
- If more than one mass is seen, only the most suspicious mass is included, or if two are similar, the largest or most accessible by ultrasound
- Patients previously recruited presenting with a different mass in a subsequent pregnancy
- Age 18 years and above
You will not qualify if you...
- Cysts clearly physiological and smaller than 5 cm in largest diameter
- Non-adnexal masses such as certain peritoneal cysts or peritoneal carcinomatosis without adnexal mass
- Denial or withdrawal of written informed consent
- Same cyst already recruited for p-IOTA in a previous pregnancy
- Age under 18 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
D
Dirk Timmerman, Professor
CONTACT
W
Wouter Froyman, Professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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