International Ovarian Tumour Analysis (IOTA) Phase 5

NCT01698632 | Unknown

• 2 other identifiers: IOTA5 S51375/B32220095331USF IRB Pro00009001
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Adnexal Masses; Ovarian Cysts; Ovarian Tumors

Keywords

Adnexal masses; Ovarian cysts; Ovarian tumors

Outcome Measures

Primary Outcomes (1)

• Frequency of complications such as rupture, torsion, or malignancy in patients with benign looking conservatively treated masses

  Up to five years

Secondary Outcomes (1)

• Test the published IOTA diagnostic models for predicting that a mass is malignant at first visit or benign

  Up to five years

Other Outcomes (2)

• Investigate factors related to the need for surgery during long-term follow-up

  Up to five years

• Study natural history of conservatively treated benign-looking adnexal masses

  Up to five years

Study Arms (1)

benign-looking adnexal masses

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women being seen for adnexal masses.

You may qualify if:

• 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.

You may not qualify if:

• Any cyst with features of malignancy is excluded from the conservative management
• The denial or withdrawal of oral informed consent

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

USF Health South Tampa Center for Advanced Healthcare

Tampa, Florida, 33606, United States

Location

Related Publications (4)

• Pascual MA, Vancraeynest L, Timmerman S, Ceusters J, Ledger A, Graupera B, Rodriguez I, Valero B, Landolfo C, Testa AC, Bourne T, Timmerman D, Valentin L, Van Calster B, Froyman W. Validation of ADNEX and IOTA two-step strategy and estimation of risk of complications during follow-up of adnexal masses in low-risk population. Ultrasound Obstet Gynecol. 2024 Sep;64(3):395-404. doi: 10.1002/uog.27642. Epub 2024 Aug 16.

  PMID: 38477179 DERIVED

• Landolfo C, Ceusters J, Valentin L, Froyman W, Van Gorp T, Heremans R, Baert T, Wouters R, Vankerckhoven A, Van Rompuy AS, Billen J, Moro F, Mascilini F, Neumann A, Van Holsbeke C, Chiappa V, Bourne T, Fischerova D, Testa A, Coosemans A, Timmerman D, Van Calster B. Comparison of the ADNEX and ROMA risk prediction models for the diagnosis of ovarian cancer: a multicentre external validation in patients who underwent surgery. Br J Cancer. 2024 Apr;130(6):934-940. doi: 10.1038/s41416-024-02578-x. Epub 2024 Jan 19.

  PMID: 38243011 DERIVED

• 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.

  PMID: 32732303 DERIVED

• 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.

  PMID: 30737137 DERIVED

MeSH Terms

Conditions

Ovarian Cysts; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Urogenital Neoplasms

Study Officials

• Dirk Timmerman, PhD

  University Hospitals, KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dirk Timmerman

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: October 3, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 14, 2020

Record last verified: 2020-04

Locations

US (1)