Clinical trial · Observational
International Ovarian Tumour Analysis (IOTA) Phase 5
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adnexal Masses | — | UNRESOLVED | — |
| Ovarian Cysts | — | UNRESOLVED | — |
| Ovarian Tumors | Ovarian Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- benign-looking adnexal masses
Primary outcomes (1)
- 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 (1)
- measure
- Test the published IOTA diagnostic models for predicting that a mass is malignant at first visit or benign
- timeFrame
- Up to five years
- description
- Also to predict complications (e.g. occurrence of malignancy and other) during long-term follow-up using the diagnostic models
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- DERIVEDPascual 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
- DERIVEDLandolfo 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
- DERIVEDVan 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
- DERIVEDFroyman 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