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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01698632
Recruitment Status : Active, not recruiting
First Posted : October 3, 2012
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Dirk Timmerman, 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.


Condition or disease
Adnexal Masses Ovarian Cysts Ovarian Tumors

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Study Type : Observational
Actual Enrollment : 15000 participants
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
Study Start Date : January 2012
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort
benign-looking adnexal masses



Primary Outcome Measures :
  1. Frequency of complications such as rupture, torsion, or malignancy in patients with benign looking conservatively treated masses [ Time Frame: Up to five years ]

Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Investigate factors related to the need for surgery during long-term follow-up [ Time Frame: Up to five years ]
  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women being seen for adnexal masses.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698632


Locations
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United States, Florida
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, United States, 33606
Sponsors and Collaborators
KU Leuven
Investigators
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Principal Investigator: Dirk Timmerman, PhD University Hospitals, KU Leuven
  Study Documents (Full-Text)

Documents provided by Dirk Timmerman, KU Leuven:
Study Protocol  [PDF] January 23, 2012
Statistical Analysis Plan  [PDF] May 28, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dirk Timmerman, Prof. Dr. Dirk Timmerman, KU Leuven
ClinicalTrials.gov Identifier: NCT01698632    
Other Study ID Numbers: IOTA5 S51375/B32220095331
USF IRB Pro00009001 ( Other Identifier: University of South Florida )
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Keywords provided by Dirk Timmerman, KU Leuven:
Adnexal masses
Ovarian cysts
Ovarian tumors
Additional relevant MeSH terms:
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Ovarian Cysts
Ovarian Neoplasms
Neoplasms
Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Urogenital Neoplasms