International Ovarian Tumour Analysis (IOTA) Phase 5 (IOTA-5)

April 12, 2020 updated by: Dirk Timmerman, KU Leuven

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • USF Health South Tampa Center for Advanced Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women being seen for adnexal masses.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
benign-looking adnexal masses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of complications such as rupture, torsion, or malignancy in patients with benign looking conservatively treated masses
Time Frame: Up to five years
Up to five years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigate factors related to the need for surgery during long-term follow-up
Time Frame: Up to five years
Up to five years
Study natural history of conservatively treated benign-looking adnexal masses
Time Frame: Up to five years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Dirk Timmerman, PhD, University Hospitals, KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 19, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 12, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOTA5 S51375/B32220095331
  • USF IRB Pro00009001 (Other Identifier: University of South Florida)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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