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

NCT03695809 — Unknown, 30 participants, Far Eastern Memorial Hospital

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Far Eastern Memorial Hospital

RegistryNCT03695809
StatusUnknown
Study typeObservational
Enrollment30 (Estimated)
SponsorFar Eastern Memorial Hospital (Other); collaborators: Gynecologic Oncology Group
ConditionsVulvar Cancer, G9a Protein
InterventionsG9a protein (Biological)
Datesstart 2018-04-20, primary completion 2024-12-31 (estimated), completion 2024-12-31 (estimated), first posted 2018-10-04, last updated 2023-03-29
Locations1 site in Taiwan

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-Summary

To assess the G9a expression in vulvar cancer

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+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.

+Arms and interventions

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

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

Other outcomes

  • Correlation between histopathologic features of vulvar intraepithelial neoplasm and G9a [1 year]: Correlation between histopathologic features of vulvar intraepithelial neoplasm and G9a

+Eligibility

Sex: Female, ages: 20 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Far Eastern Memorial HospitalBanqiao District, New TaipeiTaiwanRecruiting