Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT01698632
Status:
UNKNOWN
Last Update Posted:
2020-04-14
First Post:
2012-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
International Ovarian Tumour Analysis (IOTA) Phase 5
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-01-23', 'size': 955965, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-05T10:12', 'hasProtocol': True}, {'date': '2019-05-28', 'size': 516429, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-12T17:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-12', 'studyFirstSubmitDate': '2012-09-19', 'studyFirstSubmitQcDate': '2012-09-28', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'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', 'description': 'Also to establish descriptive curves of the longitudinal changes seen in parameters from conservatively managed benign tumors (for example, change in diameter, size of any solid component, number of papillations or color score)'}], 'primaryOutcomes': [{'measure': 'Frequency of complications such as rupture, torsion, or malignancy in patients with benign looking conservatively treated masses', 'timeFrame': 'Up to five years'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adnexal masses', 'Ovarian cysts', 'Ovarian tumors'], 'conditions': ['Adnexal Masses', 'Ovarian Cysts', 'Ovarian Tumors']}, 'referencesModule': {'references': [{'pmid': '38477179', 'type': 'DERIVED', 'citation': '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': '38243011', 'type': 'DERIVED', 'citation': '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': '32732303', 'type': 'DERIVED', '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.'}, {'pmid': '30737137', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn more about the appearance and behavior of benign-looking adnexal masses.\n\n* Benign-looking means that when viewed here by ultrasound it has the appearance of looking not harmful or not malignant.\n* 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.\n* Masses refers to a variety of structures, including but not limited to:\n\n * ovarian cysts that are fluid filled sacs within or attached to an ovary\n * ovarian tumors that can be solid tissue or a combination of cysts and solid tissue\n * hydrosalpinges that are fluid collections in the fallopian tube\n\nMany 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women being seen for adnexal masses.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any woman at least 18 years old with an adnexal mass.\n* Any mass with benign ultrasound morphology may be suitable for conservative management.\n* Pregnant patients can be included, but their data will be analysed separately.\n\nExclusion Criteria:\n\n* Cysts that are deemed to be clearly physiological and less than 3 cm in maximum diameter are not eligible for inclusion.\n* Any cyst with features of malignancy is excluded from the conservative management\n* The denial or withdrawal of oral informed consent'}, 'identificationModule': {'nctId': 'NCT01698632', 'acronym': 'IOTA-5', 'briefTitle': 'International Ovarian Tumour Analysis (IOTA) Phase 5', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IOTA5 S51375/B32220095331'}, 'secondaryIdInfos': [{'id': 'USF IRB Pro00009001', 'type': 'OTHER', 'domain': 'University of South Florida'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'benign-looking adnexal masses'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'USF Health South Tampa Center for Advanced Healthcare', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Dirk Timmerman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals, KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Dirk Timmerman', 'investigatorFullName': 'Dirk Timmerman', 'investigatorAffiliation': 'KU Leuven'}}}}