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EGCG Modulate the Cytotoxic Effects of Chemotherapeutic Agents in Human Urothelial Carcinoma Cells

NCT ID: NCT01993966

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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(-)-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.

The specific aims of the study are:

1. To explore the anti-tumor effects of EGCG on human UC cells and elucidate the possible mechanisms.
2. 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.
3. 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. .
4. To prove the in vitro findings and confirm the combinative efficacy of EGCG with chemotherapeutic agents in vivo by using the xenograft animal model.
5. To establish a novel therapeutic strategy for treatment of UC.

Conditions

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Urothelial Carcinoma

Keywords

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Urothelial carcinoma (UC), (-)-epigallocatechin-3-gallate(EGCG), chemotherapy, cytotoxicity, drug resistance, xenograft.

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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drug-resistant

specimens com from drug-resistant bladder urothelial carcinoma patients

No interventions assigned to this group

normal

specimens come from normal bladder urothelial carcinoma patients

No interventions assigned to this group

non-tumoral

specimens come from non-tumoral patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kuo-How Huang, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

No. 7, Chung Shans. Rd., Taipei, Taiwan

Locations

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Department of Urology, National Taiwan University Hospital

Taipei, No. 7, Chung Shans. Rd.,, Taiwan

Site Status

Department of Urology, National Taiwan University Hospital

Taipei, No. 7, Chung Shans. Rd., Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Kuo-How Huang, M.D., Ph.D.

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Chin-Ling Huang

Role: CONTACT

Phone: 886-2-23123456

Facility Contacts

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Kuo-How Huang, M.D.,Ph.D.

Role: primary

Chin-Ling Huang

Role: backup

Kuo-How Huang, M.D.,Ph.D.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 12901963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1394823 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19367120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19472429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17604717 (View on PubMed)

Other Identifiers

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103-002509

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

201308047RIN

Identifier Type: -

Identifier Source: org_study_id