NCT01993966

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

2.9 years

First QC Date

October 24, 2013

Last Update Submit

November 19, 2013

Conditions

Urothelial Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • The IHC staining score

    the IHC staining scores are acquired by IHC staining and assessed by pathologist. The comparisons between each specimen are determined by IHC scores.

    at the time of surgery

Study Arms (3)

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

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Urology, National Taiwan University Hospital

Taipei, No. 7, Chung Shans. Rd.,, 100, Taiwan

Location

Department of Urology, National Taiwan University Hospital

Taipei, No. 7, Chung Shans. Rd., 100, Taiwan

Location

Related Publications (5)

  • 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: 12901963BACKGROUND

  • 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: 1394823BACKGROUND

  • 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: 19367120BACKGROUND

  • 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: 19472429BACKGROUND

  • 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.

    PMID: 17604717BACKGROUND

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Kuo-How Huang, M.D.,Ph.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

886-2-23123456khhuang123@ntu.edu.tw

Chin-Ling Huang

CONTACT

886-2-23123456

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 25, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

TW(2)