Gynaecological CancersGYNGHERNCT07101081
GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
An observational study of Gynaecological Cancers, run by AstraZeneca at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gynaecological Cancers
- What is being tested?
- HER-2 Test
- How many people
- 350 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Apr 2026to 11 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: In total, 350 samples in total (100 cervical cancer, 100 endometrial cancer, 100 ovarian cancer, and 50 vulvar or vaginal cancer).
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
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.
Read the detailed description
Retrospective molecular epidemiologic study.
- Conditions
- Gynaecological Cancers
- Being tested
- HER-2 Test
- Keywords
- Gynaecological cancers, HER-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER-2 TestDiagnostic 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
HER2 IHC status as per Dako HercepTest and gastric cancer scoring criteria.
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).
Measured: Through study completation,an average of 1 year
Secondary outcomes (1)
HER2 IHC status as per Dako HercepTest and gastric cancer scoring criteria.
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).
Measured: Through study completation,an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start23 Apr 2026
- Primary completion11 Nov 2026 (estimated)
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynaecological CancersStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angélica Nogueira Rodrigues, Principal investigator, Oncoclínicas Precision Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101081
- Sponsor's protocol ID
- D9673R00061
- Acronym
- GYNGHER
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
- ClinicalTrials.gov ID
- NCT07101081
- Acronym / sponsor ID
- GYNGHER / D9673R00061
- Conditions
- Gynaecological Cancers
- Keywords
- Gynaecological cancers, HER-2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In total, 350 samples in total (100 cervical cancer, 100 endometrial cancer, 100 ovarian cancer, and 50 vulvar or vaginal cancer).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HER-2 TestSamples 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). | Diagnostic test | – |
Primary outcome
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).
1 secondary outcome
HER2 IHC status as per Dako HercepTest and gastric cancer scoring criteria.
Time frame: Through study completation,an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
Angélica Nogueira Rodrigues principal investigator
Oncoclínicas Precision Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynaecological Cancers, run by AstraZeneca at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HER2 IHC status as per Dako HercepTest and gastric cancer scoring criteria. (time frame: Through study completation,an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.