Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT03112733
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2017-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine 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': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-Κb in discrimination of benign and malignant gynecologic disease', 'timeFrame': '2 days', 'description': 'To measure serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-κB between groups and to identify a possible significant diagnostic marker'}], 'secondaryOutcomes': [{'measure': 'Efficacy of serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-Κb in predicting overall survival and disease-free survival', 'timeFrame': '1 year', 'description': 'To determine any relationship between prognosis of ovarian cancer and serum levels of four different biomarkers'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial Neoplasms', 'Ovarian Neoplasms']}, 'referencesModule': {'references': [{'pmid': '24951318', 'type': 'RESULT', 'citation': 'Lee SH, Lee JS, Lee EJ, Min KH, Hur GY, Lee SH, Lee SY, Kim JH, Lee SY, Shin C, Shim JJ, Kang KH, In KH. Serum reactive oxygen species modulator 1 (Romo1) as a potential diagnostic biomarker for non-small cell lung cancer. Lung Cancer. 2014 Aug;85(2):175-81. doi: 10.1016/j.lungcan.2014.05.023. Epub 2014 Jun 5.'}, {'pmid': '25865689', 'type': 'RESULT', 'citation': 'Xu C, Zeng XH, Wang L, Tao SQ, Wu QX, Zhu P, Deng GH, Wang YM. sFRP-4, a potential novel serum marker for chronic hepatitis B-related hepatocellular carcinoma. Hepatobiliary Pancreat Dis Int. 2015 Apr;14(2):164-70. doi: 10.1016/s1499-3872(15)60352-6.'}, {'pmid': '28319807', 'type': 'RESULT', 'citation': 'Nunes JJ, Pandey SK, Yadav A, Goel S, Ateeq B. Targeting NF-kappa B Signaling by Artesunate Restores Sensitivity of Castrate-Resistant Prostate Cancer Cells to Antiandrogens. Neoplasia. 2017 Apr;19(4):333-345. doi: 10.1016/j.neo.2017.02.002. Epub 2017 Mar 19.'}, {'pmid': '27829249', 'type': 'RESULT', 'citation': 'Edfeldt K, Daskalakis K, Backlin C, Norlen O, Tiensuu Janson E, Westin G, Hellman P, Stalberg P. DcR3, TFF3, and Midkine Are Novel Serum Biomarkers in Small Intestinal Neuroendocrine Tumors. Neuroendocrinology. 2017;105(2):170-181. doi: 10.1159/000452891. Epub 2016 Nov 9.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the usefulness of serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-κB as potential diagnostic and prognostic biomarkers in ovarian carcinoma.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ovarian carcinoma who will be operated in Cerrahpasa Medical Faculty, Division of Gynecologic Oncology will participate into the study. Additionally, women without any malignancy will participate as control group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of epithelial ovarian carcinoma.\n\nExclusion Criteria:\n\n* Patients with recurrence.\n* Patients who received neoadjuvant chemotherapy or radiotherapy\n* Presence of any secondary malignancy'}, 'identificationModule': {'nctId': 'NCT03112733', 'briefTitle': 'Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Value of TFF3, SFRP4, Romo1 and NFKB as Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers', 'orgStudyIdInfo': {'id': '83045809-604.01.02'}, 'secondaryIdInfos': [{'id': 'TAB-2017-22506', 'type': 'OTHER_GRANT', 'domain': 'Istanbul University, Scientific Research Projects'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with ovarian carcinoma', 'description': 'Serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-κB of patients with a presumed diagnosis of ovarian carcinoma will be determined prior to surgery.', 'interventionNames': ['Diagnostic Test: TFF3, SFRP4, Romo1, NFKB']}, {'label': 'Control group', 'description': 'Serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-κB of women without any adnexal mass nor malignancy will be determined to compare with other groups.', 'interventionNames': ['Diagnostic Test: TFF3, SFRP4, Romo1, NFKB']}, {'label': 'Benign adnexal mass', 'description': 'Serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-κB of women with an adnexal mass will be determined to compare with other groups.'}], 'interventions': [{'name': 'TFF3, SFRP4, Romo1, NFKB', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood samples of all participants will be collected.', 'armGroupLabels': ['Control group', 'Patients with ovarian carcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34303', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University Cerrahpasa Medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ilker Kahramanoglu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University Cerrahpasa Medical Faculty'}, {'name': 'Macit Arvas', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul University Cerrahpasa Medical Faculty'}, {'name': 'Fuat Demirkiran', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University Cerrahpasa Medical Faculty'}, {'name': 'Tugan Bese', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University Cerrahpasa Medical Faculty'}, {'name': 'Hasan Turan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University Cerrahpasa Medical Faculty'}, {'name': 'Hafize Uzun', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University Cerrahpasa Medical Faculty'}, {'name': 'Salvatore Giovanni Vitale', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Messina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All data may be shared with researchers planning to perform a metaanalysis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ilker Kahramanoglu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istanbul University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, Gynecologic Oncology Fellow', 'investigatorFullName': 'Ilker Kahramanoglu', 'investigatorAffiliation': 'Istanbul University'}}}}