NCT01968928

Brief Summary

Bladder urothelial carcinoma (UC) is a common malignancy and the incidence is increasing by years in Taiwan. Chemoresistance was inevitable in treatment of metastatic disease and lead to the ominous outcomes. To develop novel therapeutic strategies to overcome chemoresistance is imperative. Cancer cells uptake glucose at higher rates than normal tissue but use most of glucose for glycolysis even under normoxia condition, which is known as the Warburg effect. Pyruvate kinase (PK) catalyzes the last step in the process of glycolysis, and one of it isoform--PKM2 has been reported to be associated with tumor progression and some specific tissues and promotes the Warburg effect in cancer cells.

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

1 active site

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 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2013

Completed
2 months 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

October 28, 2013

Status Verified

October 1, 2013

Enrollment Period

2.9 years

First QC Date

October 21, 2013

Last Update Submit

October 24, 2013

Conditions

Bladder Urothelial Carcinoma

Keywords

Bladder urothelial carcinoma (UC)pyruvate kinasedrug resistanceshikonin

Outcome Measures

Primary Outcomes (1)

  • The IHC score

    the IHC scores are acquired by IHC staining and 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:

  • patients with age between 20-80 years old and had taken Radical Cystectomy or nephrectomy between 2008-2012

You may not qualify if:

  • patients with age not located in the interval of 20-80 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Related Publications (4)

  • Vander Heiden MG, Cantley LC, Thompson CB. Understanding the Warburg effect: the metabolic requirements of cell proliferation. Science. 2009 May 22;324(5930):1029-33. doi: 10.1126/science.1160809.

    PMID: 19460998BACKGROUND

  • Christofk HR, Vander Heiden MG, Harris MH, Ramanathan A, Gerszten RE, Wei R, Fleming MD, Schreiber SL, Cantley LC. The M2 splice isoform of pyruvate kinase is important for cancer metabolism and tumour growth. Nature. 2008 Mar 13;452(7184):230-3. doi: 10.1038/nature06734.

    PMID: 18337823BACKGROUND

  • Chen J, Xie J, Jiang Z, Wang B, Wang Y, Hu X. Shikonin and its analogs inhibit cancer cell glycolysis by targeting tumor pyruvate kinase-M2. Oncogene. 2011 Oct 20;30(42):4297-306. doi: 10.1038/onc.2011.137. Epub 2011 Apr 25.

    PMID: 21516121BACKGROUND

  • Yang W, Lu Z. Regulation and function of pyruvate kinase M2 in cancer. Cancer Lett. 2013 Oct 10;339(2):153-8. doi: 10.1016/j.canlet.2013.06.008. Epub 2013 Jun 18.

    PMID: 23791887BACKGROUND

Biospecimen

Retention: NONE RETAINED

Tissue samples of tumors as well as normal-appearing mucosa collected in the tissue bank are to be used to examine the cellular and molecular events involved. Comparisons will be made to differentiate cellular changes between tumors and the normal counterparts.

Study Officials

  • Kuo-How Huang, M.D., Ph.D.

    Department of Urology, National Taiwan University Hospital, 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 21, 2013

First Posted

October 24, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 28, 2013

Record last verified: 2013-10

Locations

TW(1)