International Ovarian Tumour Analysis (IOTA) Phase 5
| Status: | Recruiting |
|---|---|
| Conditions: | Ovarian Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2019 |
| Start Date: | January 2012 |
| End Date: | December 2021 |
| Contact: | Dirk Timmerman, PhD |
| Email: | dirk.timmerman@uzleuven.be |
| Phone: | +32 16 344215 |
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.
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.
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
We found this trial at
1
site
Tampa, Florida 33606
Principal Investigator: Lauri Hochberg, MD
Phone: 813-259-0808
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