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

Vulvar Cancer, G9a Protein Clinical Trial

Official title:

Far Eastern Memorial Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03695809
• Other study ID #: 107008-F
• Status: Recruiting
• Start date: April 20, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Far Eastern Memorial Hospital
• Contact: Sheng-Mou Hsiao, MD
• Phone: +886289667000
• Email: smhsiao2[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the G9a expression in vulvar cancer

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vulvar Cancer, G9a Protein
• Vulvar Neoplasms

Intervention

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

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Banqiao	New Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital	Gynecologic Oncology Group

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between histopathologic features of vulvar intraepithelial neoplasm and G9a	Correlation between histopathologic features of vulvar intraepithelial neoplasm and G9a	1 year
Primary	Correlation between clinical outcome of vulvar cancer and G9a	The association of G9a protein and clinical outcome (such as overall survival and progression-free survival) of patients with vulvar cancer	5 years
Secondary	Correlation between histopathologic features of vulvar cancer and G9a	Correlation between histopathologic features (such as tumor grade, lymphovascular space invasion, lymph node metastasis and tumor size) of vulvar cancer and G9a	1 year