International Ovarian Tumour Analysis (IOTA) Phase 5

• Conditions: Adnexal Masses; Ovarian Cysts; Ovarian Tumors

• Registration Number: NCT01698632
• Lead Sponsor: KU Leuven

Brief Summary

The purpose of this study is to learn more about the appearance and behavior of benign-looking adnexal masses.

* Benign-looking means that when viewed here by ultrasound it has the appearance of looking not harmful or not malignant.

* Adnexal refers to the 'adnexa', the space in the female pelvis on either side of the uterus (or where the uterus used to be if you previously had a hysterectomy). The adnexa includes, but is not limited to, the ovaries and the fallopian tubes.

* Masses refers to a variety of structures, including but not limited to:

* ovarian cysts that are fluid filled sacs within or attached to an ovary

* ovarian tumors that can be solid tissue or a combination of cysts and solid tissue

* hydrosalpinges that are fluid collections in the fallopian tube

Many women have what appear to be benign adnexal masses. Many times, removal of the masses with surgery is not necessary. Often surgery is performed unnecessarily, for fear that these masses could be cancer. There is not much information available for doctors to know how and when to follow these masses, or which ones will become cancer.

This study will combine information from centers all around the world regarding the behavior of all types of benign adnexal masses. The aim of this study is to develop decision tools for doctors to know the best way to treat these masses in order to improve the detection of ovarian cancer while at the same time reduce the number of unnecessary operations.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-03
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-12
• Last Update Posted: 2020-04-14
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 15000

Inclusion Criteria

• Any woman at least 18 years old with an adnexal mass.
• Any mass with benign ultrasound morphology may be suitable for conservative management.
• Pregnant patients can be included, but their data will be analysed separately.

Exclusion Criteria

• Cysts that are deemed to be clearly physiological and less than 3 cm in maximum diameter are not eligible for inclusion.
• Any cyst with features of malignancy is excluded from the conservative management
• The denial or withdrawal of oral informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of complications such as rupture, torsion, or malignancy in patients with benign looking conservatively treated masses	Up to five years

Secondary Outcome Measures

Name	Time	Method
Test the published IOTA diagnostic models for predicting that a mass is malignant at first visit or benign	Up to five years	Also to predict complications (e.g. occurrence of malignancy and other) during long-term follow-up using the diagnostic models

Trial Locations

Locations (1)

USF Health South Tampa Center for Advanced Healthcare; 🇺🇸 Tampa, Florida, United States