Actively Recruiting
GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
Led by AstraZeneca · Updated on 2026-05-01
350
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at sample collection
- Diagnosis of cervical, endometrial, ovarian/peritoneum/uterine tube, vulvar, or vaginal cancers
- Sufficient paraffin primary tumor tissue available for biomarker testing in OC Precision Medicine Pathology labs
- Date of gynecological cancer diagnosis between January 2020 and March 2025
- Signed informed consent or waiver of informed consent granted
You will not qualify if you...
- Insufficient paraffin tissue for biomarker testing
- Diagnosis made from metastatic lesion
- History of systemic anti-cancer therapies before surgery or biopsy for the gynecological cancer diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Site
São Paulo, Brazil
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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