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

Catholic University (KU) of Leuven

Status: Unknown

Conditions: Ovarian Tumors; Ovarian Cysts; Adnexal Masses

Study type: Observational

Funder types: Other

Identifiers

NCT01698632

IOTA5 S51375/B32220095331

USF IRB Pro00009001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 15,000 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

15,000 participants in 1 patient group

benign-looking adnexal masses