International Ovarian Tumour Analysis (IOTA) Phase 5 (IOTA-5)
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- Frequency of complications such as rupture, torsion, or malignancy in patients with benign looking conservatively treated masses [ Time Frame: Up to five years ] [ Designated as safety issue: Yes ]
- Test the published IOTA diagnostic models for predicting that a mass is malignant at first visit or benign [ Time Frame: Up to five years ] [ Designated as safety issue: No ]Also to predict complications (e.g. occurrence of malignancy and other) during long-term follow-up using the diagnostic models
- Investigate factors related to the need for surgery during long-term follow-up [ Time Frame: Up to five years ] [ Designated as safety issue: No ]
- Study natural history of conservatively treated benign-looking adnexal masses [ Time Frame: Up to five years ] [ Designated as safety issue: No ]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)
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
|benign-looking adnexal masses|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698632
|United States, Florida|
|USF Health South Tampa Center for Advanced Healthcare|
|Tampa, Florida, United States, 33606|
|Principal Investigator:||Lauri Hochberg, MD||University of South Florida|