NCT07101081Recruiting
GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 350 (estimated)
- First submitted
- 16 Jul 2025
- Start date
- 23 Apr 2026
- Primary completion date
- 11 Nov 2026
- Lead sponsor
- AstraZeneca
- Diseases
- Childhood cancers
- NCT number
- NCT07101081
What you commit to
- Study type: Observational
- Planned participants: 350
- From 23 Apr 2026 to the primary completion date, 11 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- Patients without sufficient paraffin tissue for the proposed biomarker testing.
- Patients whose diagnosis was performed in metastatic lesion.
Who the study is looking for
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.