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Trial record 6 of 383 for:    Ovarian Cysts: Ovarian Cysts

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01698632
First received: September 19, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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
Adnexal Masses
Ovarian Cysts
Ovarian Tumors

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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)


Estimated Enrollment: 200
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)
Groups/Cohorts
benign-looking adnexal masses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women being seen at the University of South Florida South Tampa Center

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698632

Locations
United States, Florida
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Lauri Hochberg, MD University of South Florida
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01698632     History of Changes
Other Study ID Numbers: USF IRB Pro00009001
Study First Received: September 19, 2012
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board
Belgium: Ethics Committee

Keywords provided by University of South Florida:
Adnexal masses
Ovarian cysts
Ovarian tumors

Additional relevant MeSH terms:
Ovarian Cysts
Ovarian Neoplasms
Cysts
Ovarian Diseases
Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014