GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort

NCT ID: NCT07101081

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2026-01-05

Brief Summary

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.

Detailed Description

Retrospective molecular epidemiologic study.

Conditions

Gynaecological Cancers

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

HER-2 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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angélica Nogueira Rodrigues

Role: PRINCIPAL_INVESTIGATOR

Oncoclínicas Precision Medicine

Locations

Oncoclínicas Precision Medicine

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

AstraZeneca Clinical Study Information Center

Role: CONTACT

information.center@astrazeneca.com

1-877-240-9479

Other Identifiers

D9673R00061

Identifier Type: -

Identifier Source: org_study_id