Clinical trial NCT01698632: International Ovarian Tumour Analysis (IOTA) Phase 5
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adnexal Masses
Ovarian Cysts
Ovarian Tumors
Keywords: Adnexal masses
Ovarian cysts
Ovarian tumors
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 15000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women being seen for adnexal masses.

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.


Eligibility 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

Primary outcomes:
measure: Frequency of complications such as rupture, torsion, or malignancy in patients with benign looking conservatively treated masses
timeFrame: Up to five years
Secondary outcomes:
measure: Test the published IOTA diagnostic models for predicting that a mass is malignant at first visit or benign
timeFrame: Up to five years
Other outcomes:
measure: Investigate factors related to the need for surgery during long-term follow-up
timeFrame: Up to five years
measure: Study natural history of conservatively treated benign-looking adnexal masses
timeFrame: Up to five years
Locations:
city: Tampa
country: United States
facility: USF Health South Tampa Center for Advanced Healthcare
state: Florida
Study officials:
affiliation: University Hospitals, KU Leuven
name: Dirk Timmerman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Calster B, Valentin L, Froyman W, Landolfo C, Ceusters J, Testa AC, Wynants L, Sladkevicius P, Van Holsbeke C, Domali E, Fruscio R, Epstein E, Franchi D, Kudla MJ, Chiappa V, Alcazar JL, Leone FPG, Buonomo F, Coccia ME, Guerriero S, Deo N, Jokubkiene L, Savelli L, Fischerova D, Czekierdowski A, Kaijser J, Coosemans A, Scambia G, Vergote I, Bourne T, Timmerman D. Validation of models to diagnose ovarian cancer in patients managed surgically or conservatively: multicentre cohort study. BMJ. 2020 Jul 30;370:m2614. doi: 10.1136/bmj.m2614.
citation: Froyman W, Landolfo C, De Cock B, Wynants L, Sladkevicius P, Testa AC, Van Holsbeke C, Domali E, Fruscio R, Epstein E, Dos Santos Bernardo MJ, Franchi D, Kudla MJ, Chiappa V, Alcazar JL, Leone FPG, Buonomo F, Hochberg L, Coccia ME, Guerriero S, Deo N, Jokubkiene L, Kaijser J, Coosemans A, Vergote I, Verbakel JY, Bourne T, Van Calster B, Valentin L, Timmerman D. Risk of complications in patients with conservatively managed ovarian tumours (IOTA5): a 2-year interim analysis of a multicentre, prospective, cohort study. Lancet Oncol. 2019 Mar;20(3):448-458. doi: 10.1016/S1470-2045(18)30837-4. Epub 2019 Feb 5.