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

Recruiting

• Conditions: Vulvar Cancer, G9a Protein

• Registration Number: NCT03695809
• Lead Sponsor: 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 Timeline

• Study Start: 2018-04-20
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between clinical outcome of vulvar cancer and G9a	5 years	The association of G9a protein and clinical outcome (such as overall survival and progression-free survival) of patients with vulvar cancer

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan