Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-03 @ 10:34 PM
Study NCT ID:
NCT06309459
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2024-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Postop mastectomy pathologic materials'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2024-01-10', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Poor prognostic factors in patients with TNBC', 'timeFrame': '2018-2023', 'description': "Higher staining CA IX levels (≥ 10%) in TNBC patients' pathological specimens is a poor prognostic factor"}, {'measure': "The treatment success with inhibiting the CA IX enzyme levels' effectiveness", 'timeFrame': '2018-2023', 'description': 'Treatment success in TNBC patients by evaluating changes in CA IX staining levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Triple negative breast carcinoma', 'Carbonic anhydrase IX', 'Treatment effect', 'Ki67 proliferation index'], 'conditions': ['Triple Negative Breast Cancer', 'Carbonic Anhydrase IX']}, 'referencesModule': {'references': [{'pmid': '35933373', 'type': 'BACKGROUND', 'citation': 'Bakherad H, Ghasemi F, Hosseindokht M, Zare H. Nanobodies; new molecular instruments with special specifications for targeting, diagnosis and treatment of triple-negative breast cancer. Cancer Cell Int. 2022 Aug 6;22(1):245. doi: 10.1186/s12935-022-02665-0.'}, {'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}, {'pmid': '32517735', 'type': 'BACKGROUND', 'citation': 'Yin L, Duan JJ, Bian XW, Yu SC. Triple-negative breast cancer molecular subtyping and treatment progress. Breast Cancer Res. 2020 Jun 9;22(1):61. doi: 10.1186/s13058-020-01296-5.'}, {'pmid': '19872213', 'type': 'BACKGROUND', 'citation': 'Warburg O, Wind F, Negelein E. THE METABOLISM OF TUMORS IN THE BODY. J Gen Physiol. 1927 Mar 7;8(6):519-30. doi: 10.1085/jgp.8.6.519. No abstract available.'}, {'pmid': '35150959', 'type': 'BACKGROUND', 'citation': 'Carroll CP, Bolland H, Vancauwenberghe E, Collier P, Ritchie AA, Clarke PA, Grabowska AM, Harris AL, McIntyre A. Targeting hypoxia regulated sodium driven bicarbonate transporters reduces triple negative breast cancer metastasis. Neoplasia. 2022 Mar;25:41-52. doi: 10.1016/j.neo.2022.01.003. Epub 2022 Feb 9.'}, {'pmid': '32144406', 'type': 'BACKGROUND', 'citation': 'Lee P, Chandel NS, Simon MC. Cellular adaptation to hypoxia through hypoxia inducible factors and beyond. Nat Rev Mol Cell Biol. 2020 May;21(5):268-283. doi: 10.1038/s41580-020-0227-y. Epub 2020 Mar 6.'}, {'pmid': '35203334', 'type': 'BACKGROUND', 'citation': 'Godet I, Doctorman S, Wu F, Gilkes DM. Detection of Hypoxia in Cancer Models: Significance, Challenges, and Advances. Cells. 2022 Feb 16;11(4):686. doi: 10.3390/cells11040686.'}, {'pmid': '29891961', 'type': 'BACKGROUND', 'citation': 'Gillies RJ, Brown JS, Anderson ARA, Gatenby RA. Eco-evolutionary causes and consequences of temporal changes in intratumoural blood flow. Nat Rev Cancer. 2018 Sep;18(9):576-585. doi: 10.1038/s41568-018-0030-7.'}, {'pmid': '35659268', 'type': 'BACKGROUND', 'citation': 'Wu Q, You L, Nepovimova E, Heger Z, Wu W, Kuca K, Adam V. Hypoxia-inducible factors: master regulators of hypoxic tumor immune escape. J Hematol Oncol. 2022 Jun 3;15(1):77. doi: 10.1186/s13045-022-01292-6.'}]}, 'descriptionModule': {'briefSummary': 'Triple-negative breast carcinoma is characterized by the absence of estrogen receptors, progesterone receptors, and HER2/neu receptors. Carbonic anhydrase IX (CA IX) is a tumor-associated cell surface glycoprotein that is involved in adaptation to hypoxia-induced acidosis and plays a role in cancer progression. This study aimed to investigate CA IX expression in TNBC and its relationship with treatment effect.', 'detailedDescription': 'Tru-cut biopsy materials, sent to our hospital pathology laboratory between August 2018 and May 2023, will be examined. Invasive carcinoma cases will be evaluated according to estrogen, progesterone, and HER 2 receptor levels. Triple-negative tumor cases were isolated and those cases who underwent breast resection in our hospital after receiving neoadjuvant chemotherapy (Adriamycin, cyclophosphamide, and then paclitaxel for 4 cycles) were included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Triple Negative Breast Cancer cases who were operated in Elazığ Fethi Sekin SUAM', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years\n* Triple-negative mastectomy cases\n* Patients whose data can be available\n* Patients who were operated in our hospital\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Not triple negative mastectomy cases\n* Patients with missing data\n* Patients who were operated in another hospital'}, 'identificationModule': {'nctId': 'NCT06309459', 'briefTitle': 'Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma: Relationship With Prognostic Factors and Response to Neoadjuvant Chemotherapy', 'orgStudyIdInfo': {'id': 'IRB 2023/04-34'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low Staining', 'description': 'CA IX is a transmembrane protein, it exhibits cytoplasmic membrane staining. Immunohistochemically positive cells were graded as Low staining if they constituted \\<10% of the total.', 'interventionNames': ['Diagnostic Test: Carbonic anhydrase staining levels']}, {'label': 'High Staining', 'description': 'CA IX is a transmembrane protein, it exhibits cytoplasmic membrane staining. Immunohistochemically positive cells were graded as high staining if they constituted ≥ 10%', 'interventionNames': ['Diagnostic Test: Carbonic anhydrase staining levels']}], 'interventions': [{'name': 'Carbonic anhydrase staining levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'CA IX is a transmembrane protein, it exhibits cytoplasmic membrane staining. Immunohistochemically positive cells were graded as Low staining if they constituted \\<10% of the total and high staining if they constituted ≥ 10% (15).', 'armGroupLabels': ['High Staining', 'Low Staining']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Kahramanmaraş', 'country': 'Turkey (Türkiye)', 'facility': 'Kahramanmaraş Sütçü İmam University', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Associate', 'investigatorFullName': 'Mehmet Buğra Bozan', 'investigatorAffiliation': 'Elazıg Fethi Sekin Sehir Hastanesi'}}}}