The Association of G9a Protein and Clinical Outcome of Patients With Vulvar Cancer

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Sheng-Mou Hsiao，Far Eastern Memorial Hospital

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

April 20, 2018

Estimated Primary Completion Date

January 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Correlation between clinical outcome of vulvar cancer and G9a[ Time Frame: 5 years ]

The association of G9a protein and clinical outcome (such as overall survival and progression-free survival) of patients with vulvar cancer

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Correlation between histopathologic features of vulvar cancer and G9a[ Time Frame: 1 year ]
Correlation between histopathologic features (such as tumor grade, lymphovascular space invasion, lymph node metastasis and tumor size) of vulvar cancer and G9a

Descriptive Information

Brief Title ^ICMJE

The Association of G9a Protein and Clinical Outcome of Patients With Vulvar Cancer

Official Title ^ICMJE

Far Eastern Memorial Hospital

Brief Summary

To assess the G9a expression in vulvar cancer

Detailed Description

Vulvar cancer can be treated with surgery, radiotherapy or chemoradiotherapy. Recurrence of vulvar cancer generally can be detected by imaging study. Currently, there is a paucity of sensitive marker to detect the recurrence of vulvar cancer. G9a is a recently identified protein with histone lysine methyltransferase activity. The role of histone methyltransferases in promoting tumorigenesis and progression of human cancers has been noted in some cancers, such as ovarian cancer, endometrial cancer and cervical cancer. The role of G9a protein in vulvar cancer remains obscure. All female patients with vulvar cancer or vulvar intraepithelial neoplasm II /III who underwent surgery at Far Eastern Memorial Hospital from January 2003 will be included. All patients' clinical characteristerics including age, stage, pathologic finding, and follow-up data will be recorded from chart review. The archived specimens will be used for immunohistochemical staining of G9a protein. Tumor size, local invasion, lymph node metastasis, and final disease stage will be determined. Correlation will be performed between G9a and clinical outcome of vulvar cancer.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Biological: G9a protein
To assess G9a protein expression on vulvar cancer

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

January 31, 2019

Estimated Primary Completion Date

January 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - All female patients with vulvar cancer or vulvar intraepithelial neoplasm II /III who underwent surgery at Far Eastern Memorial Hospital from January 2003 were included. Exclusion Criteria:

Sex/Gender

Sexes Eligible for Study:

Female

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Taiwan

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Sheng-Mou Hsiao，Far Eastern Memorial Hospital

Study Sponsor ^ICMJE

Far Eastern Memorial Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Far Eastern Memorial Hospital

Verification Date

May 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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