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

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ClinicalTrials.gov Identifier: NCT01993966
Recruitment Status : Unknown
Verified November 2013 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
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.

Condition or disease
Urothelial Carcinoma

Detailed Description:

(-)-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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Mechanism of (-)-Epigallocatechin -3-gallate (EGCG) to Modulate the Cytotoxic Effects of Chemotherapeutic Agents in Human Urothelial Carcinoma Cells
Study Start Date : January 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort
drug-resistant
specimens com from drug-resistant bladder urothelial carcinoma patients
normal
specimens come from normal bladder urothelial carcinoma patients
non-tumoral
specimens come from non-tumoral patients



Primary Outcome Measures :
  1. The IHC staining score [ Time Frame: at the time of surgery ]
    the IHC staining scores are acquired by IHC staining and assessed by pathologist. The comparisons between each specimen are determined by IHC scores.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with age between 20-80 years old and had taken Radical Cystectomy or nephrectomy between 2008-2012 were chosen as study population
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993966


Contacts
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Contact: Kuo-How Huang, M.D., Ph.D. 886-2-23123456 ext 65952 khhuang123@ntu.edu.tw
Contact: Chin-Ling Huang 886-2-23123456 ext 65233

Locations
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Taiwan
Department of Urology, National Taiwan University Hospital Not yet recruiting
Taipei, No. 7, Chung Shans. Rd.,, Taiwan, 100
Contact: Kuo-How Huang, M.D.,Ph.D.    886-2-23123456      
Contact: Chin-Ling Huang    886-2-23123456 ext 65233    d95447004@ntu.edu.tw   
Department of Urology, National Taiwan University Hospital Not yet recruiting
Taipei, No. 7, Chung Shans. Rd., Taiwan, 100
Contact: Kuo-How Huang, M.D.,Ph.D.    886-2-23123456 ext 65952    khhuang123@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Kuo-How Huang, M.D.,Ph.D. No. 7, Chung Shans. Rd., Taipei, Taiwan

Additional Information:

Publications:
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01993966     History of Changes
Other Study ID Numbers: 201308047RIN
103-002509 ( Other Grant/Funding Number: National Taiwan University Hospital )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by National Taiwan University Hospital:
Urothelial carcinoma (UC),
(-)-epigallocatechin-3-gallate(EGCG),
chemotherapy,
cytotoxicity,
drug resistance,
xenograft.

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Antineoplastic Agents