International Ovarian Tumour Analysis (IOTA) Phase 5

Ovarian Cysts Clinical Trial

— IOTA-5  

Official title:

A Multicentre Study to Examine the Short and Long Term Outcomes of the Conservative Management of Benign-looking Adnexal Masses and the Pre-operative Characterisation of Ovarian Tumours

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01698632
• Other study ID #: IOTA5 S51375/B32220095331
• Secondary ID: USF IRB Pro00009
• Status: Active, not recruiting
• Start date: January 2012
• Est. completion date: December 2021

Study information

• Verified date: April 2020
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15000
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adnexal Masses
• Ovarian Cysts
• Ovarian Neoplasms
• Ovarian Tumors

Locations

Country	Name	City	State
United States	USF Health South Tampa Center for Advanced Healthcare	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Investigate factors related to the need for surgery during long-term follow-up		Up to five years
Other	Study natural history of conservatively treated benign-looking adnexal masses	Also to establish descriptive curves of the longitudinal changes seen in parameters from conservatively managed benign tumors (for example, change in diameter, size of any solid component, number of papillations or color score)	Up to five years
Primary	Frequency of complications such as rupture, torsion, or malignancy in patients with benign looking conservatively treated masses		Up to five years
Secondary	Test the published IOTA diagnostic models for predicting that a mass is malignant at first visit or benign	Also to predict complications (e.g. occurrence of malignancy and other) during long-term follow-up using the diagnostic models	Up to five years