Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-19 @ 3:34 AM
Study NCT ID:
NCT01993966
Status:
UNKNOWN
Last Update Posted:
2013-11-25
First Post:
2013-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EGCG Modulate the Cytotoxic Effects of Chemotherapeutic Agents in Human Urothelial Carcinoma Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-19', 'studyFirstSubmitDate': '2013-10-24', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The IHC staining score', 'timeFrame': 'at the time of surgery', 'description': 'the IHC staining scores are acquired by IHC staining and assessed by pathologist. The comparisons between each specimen are determined by IHC scores.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urothelial carcinoma (UC),', '(-)-epigallocatechin-3-gallate(EGCG),', 'chemotherapy,', 'cytotoxicity,', 'drug resistance,', 'xenograft.'], 'conditions': ['Urothelial Carcinoma']}, 'referencesModule': {'references': [{'pmid': '12901963', 'type': 'BACKGROUND', 'citation': 'Hussain SA, James ND. The systemic treatment of advanced and metastatic bladder cancer. Lancet Oncol. 2003 Aug;4(8):489-97. doi: 10.1016/s1470-2045(03)01168-9.'}, {'pmid': '1394823', 'type': 'BACKGROUND', 'citation': 'Ueki O, Hisazumi H, Uchibayashi T, Naito K, Tajiri S, Takemae K, Kawaguchi K, Kameda K, Nishino A, Nango C, et al. Methotrexate, vinblastine, doxorubicin, and cisplatin for advanced urothelial cancer. Cancer Chemother Pharmacol. 1992;30 Suppl:S72-6. doi: 10.1007/BF00686947.'}, {'pmid': '19367120', 'type': 'BACKGROUND', 'citation': 'Tachibana H. Molecular basis for cancer chemoprevention by green tea polyphenol EGCG. Forum Nutr. 2009;61:156-169. doi: 10.1159/000212748. Epub 2009 Apr 7.'}, {'pmid': '19472429', 'type': 'BACKGROUND', 'citation': 'Yang CS, Wang X, Lu G, Picinich SC. Cancer prevention by tea: animal studies, molecular mechanisms and human relevance. Nat Rev Cancer. 2009 Jun;9(6):429-39. doi: 10.1038/nrc2641.'}, {'pmid': '17604717', 'type': 'BACKGROUND', 'citation': 'Manning BD, Cantley LC. AKT/PKB signaling: navigating downstream. Cell. 2007 Jun 29;129(7):1261-74. doi: 10.1016/j.cell.2007.06.009.'}]}, 'descriptionModule': {'briefSummary': 'Urothelial carcinoma (UC) is the most common cancer of urinary tract. Patients with metastatic UC are usually treated with systemic chemotherapy. There still existed 30% to 50% of advanced UC not responsive to cisplatin-based chemotherapy; the prognosis for patients with metastatic UC remains poor.', 'detailedDescription': '(-)-epigallocatechin -3-gallate (EGCG) is the most abundant polyphenol compound from green tea, representing \\~16.5% of the water-extractable fraction. EGCG have various bioactivities and can bind and regulate a wide range of molecular involved in cell cycle, signal transduction, and protein degradation. However, the anticancer effects of EGCG on UC have not been thoroughly explored. Our preliminary data show that EGCG alone can inhibit cell proliferation and induce apoptosis with the activation of caspases and PARP in a time dependent manner. Moreover, EGCG can enhance the cytotoxicity of several chemotherapeutic drugs in vitro. The underlying mechanism seems to be associated with Akt and ERK pathway. We will also check the Akt and ERK protein level by immunohistochemical staining in clinically chemoreistant bladder urothelial carcinoma specimens to further prove our in vitro findings. We will further confirm the effect of chemotherapeutic drugs combined with EGCG on UC in vivo via xenograft model.\n\nThe specific aims of the study are:\n\n1. To explore the anti-tumor effects of EGCG on human UC cells and elucidate the possible mechanisms.\n2. To study the combinative cytotoxic effect of EGCG with other chemotherapeutic agents such as cisplatin, doxorubicin and gemcitabine on UC cells; moreover, to investigate the underlying mechanisms.\n3. To investigate the expression level of phospho-Akt and phospho-ERK in clinically chemoreistant bladder urothelial carcinoma specimens to further confirm our finding in clinical events. .\n4. To prove the in vitro findings and confirm the combinative efficacy of EGCG with chemotherapeutic agents in vivo by using the xenograft animal model.\n5. To establish a novel therapeutic strategy for treatment of UC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with age between 20-80 years old and had taken Radical Cystectomy or nephrectomy between 2008-2012 were chosen as study population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In January 2008 to December 2012 at the National Taiwan University Hospital for surgery (radical resection of kidney and ureter or bladder removal) of urothelial carcinoma histopathology specimens of patients willing to participate in this study and the subjects described in the consent Book signer.\n\nExclusion Criteria:\n\n* In January 2008 to December 2012 at the National Taiwan University Hospital for surgery (radical resection of kidney and ureter or bladder removal) of urothelial carcinoma histopathology specimens of patients are reluctant to join the researcher'}, 'identificationModule': {'nctId': 'NCT01993966', 'briefTitle': 'EGCG Modulate the Cytotoxic Effects of Chemotherapeutic Agents in Human Urothelial Carcinoma Cells', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Mechanism of (-)-Epigallocatechin -3-gallate (EGCG) to Modulate the Cytotoxic Effects of Chemotherapeutic Agents in Human Urothelial Carcinoma Cells', 'orgStudyIdInfo': {'id': '201308047RIN'}, 'secondaryIdInfos': [{'id': '103-002509', 'type': 'OTHER_GRANT', 'domain': 'National Taiwan University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'drug-resistant', 'description': 'specimens com from drug-resistant bladder urothelial carcinoma patients'}, {'label': 'normal', 'description': 'specimens come from normal bladder urothelial carcinoma patients'}, {'label': 'non-tumoral', 'description': 'specimens come from non-tumoral patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'No. 7, Chung Shans. Rd.,', 'country': 'Taiwan', 'contacts': [{'name': 'Kuo-How Huang, M.D.,Ph.D.', 'role': 'CONTACT', 'phone': '886-2-23123456'}, {'name': 'Chin-Ling Huang', 'role': 'CONTACT', 'email': 'd95447004@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '65233'}], 'facility': 'Department of Urology, National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '100', 'city': 'Taipei', 'state': 'No. 7, Chung Shans. Rd.', 'country': 'Taiwan', 'contacts': [{'name': 'Kuo-How Huang, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'khhuang123@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '65952'}], 'facility': 'Department of Urology, National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Kuo-How Huang, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'khhuang123@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '65952'}, {'name': 'Chin-Ling Huang', 'role': 'CONTACT', 'phone': '886-2-23123456', 'phoneExt': '65233'}], 'overallOfficials': [{'name': 'Kuo-How Huang, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'No. 7, Chung Shans. Rd., Taipei, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}