Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07101081

GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gynaecological Cancers

Sex eligibility

Female

Study type

Observational

Primary location

Research Site

São Paulo, Brazil

Location status: Recruiting

About this study

Retrospective molecular epidemiologic study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 2025.
  • Patients need to sign informed consent, or waiver of informed consent is granted.

Exclusion criteria

  • 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).

Treatment and study plan

HER-2 Test

Diagnostic Test

Samples from patients with gynecological tumors eligible to the study will be retrospectively identified and the paraffin slides will be sent to central laboratory to perform HER2 IHC testing using the automated protocols (Dako and Ventana). Expert pathologists will select primary tumor samples from surgery or excisional biopsies with enough material to perform HER2 testing using both antibodies without exhausting the cancer tissue. The entire cohort will be tested with both Dako HercepTest and Roche Ventana 4B5 antibody using gastric cancer and breast cancer criteria for positivity (3+, 2+ and 1+, 0).

Primary outcomes

  1. HER2 IHC status as per Dako HercepTest and gastric cancer scoring criteria.

    Time frame: 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).

Secondary outcomes

  1. HER2 IHC status as per Dako HercepTest and gastric cancer scoring criteria.

    Time frame: Through study completation,an average of 1 year

    To describe HER2 expression levels (IHC 0, 1+ and 2+) in a cohort of patients in Brazil with gynecological cancers (cervical, endometrial and ovarian, vulvar and vaginal cancers).

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: GYNGHER

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.