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Recruiting NCT07101081

GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort

— Observational Gynaecological Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HER-2 Test.
Who it may be relevant to
Registry conditions: Gynaecological Cancers. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test 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

Primary outcome measures

  • HER2 IHC status as per Dako HercepTest and gastric cancer scoring criteria. [Time frame: Through study completation,an average of 1 year]
Secondary outcome measures (1)
  • HER2 IHC status as per Dako HercepTest and gastric cancer scoring criteria. [Time frame: Through study completation,an average of 1 year]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Brazil · 1 center
  • Research Site — São Paulo

Identifiers

NCT: NCT07101081 · D9673R00061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗