GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- HER2 IHC status as per Dako HercepTest and gastric cancer scoring criteria.
研究概览
简要总结
Adult patients with gynecologic cancer (endometrial, ovarian, cervical, vulvar and vaginal cancers) treated at Oncoclínicas & CO sites will be enrolled for primary tumor immunohistochemistry (IHC) analysis. When sufficient paraffin tissue is available for biomarker testing, slides will be sent from partner Pathology Labs of the OC Precision Medicine network to Locus Lab (São Paulo) for HER2 staining with automated protocols (Dako HercepTest and Roche Ventana 4B5) and scoring using different criteria (gastric cancer, breast cancer, and endometrial cancer). Primary objective is to describe the prevalence of HER2 high expression (IHC 3+ using Dako HercepTest and gastric cancer scoring criteria) in endometrial, ovarian, and cervical cancers (common gynecological malignancies). Secondary objectives are to describe the prevalence of HER2 high expression (IHC 3+ using Dako HercepTest and gastric cancer scoring criteria) in vulvar and vaginal cancers (rare gynecological malignancies); and to describe the prevalence of different HER2 expression levels (IHC 0, 1+ and 2+ using Dako HercepTest and gastric cancer scoring criteria) across all gynecological malignancies, to describe HER2 expression levels as per endometrial cancer scoring criteria in the endometrial cohort; to describe the association of different histological subtypes of gynecological cancer with HER2 IHC expression levels.
详细描述
Retrospective molecular epidemiologic study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years at sample collection; - Diagnosis of cervical, endometrial, ovarian/peritoneum/uterine tube, vulvar, or vaginal cancers;
- •Sufficient paraffin primary tumor tissue for biomarker testing in the OC Precision Medicine Pathology labs.
- •Date of diagnosis of gynecological cancer must be from January 2020 to March
- •Patients need to sign informed consent, or waiver of informed consent is granted.
排除标准
- •Patients without sufficient paraffin tissue for the proposed biomarker testing.
- •Patients whose diagnosis was performed in metastatic lesion.
- •Patients with history of exposure to systemic anti-cancer therapies for the gynecological cancer diagnosis before surgery or excisional biopsy of gynecological cancer (information is available in the original histopathology request document stored in the LIMS).
结局指标
主要结局
HER2 IHC status as per Dako HercepTest and gastric cancer scoring criteria.
时间窗: Through study completation,an average of 1 year
To describe the prevalence of HER2 high expression (IHC 3+) in a cohort of patients in Brazil with gynecological cancers (cervical, endometrial and ovarian cancers).
次要结局
- HER2 IHC status as per Dako HercepTest and gastric cancer scoring criteria.(Through study completation,an average of 1 year)