Investigating HER2 prevalence in gynecologic cancers in Taiwan
A Retrospective, Non-interventional, Multicenter Study to Investigate the Prevalence of HER2 IHC 3+ and Characterize the Clinicopathologic Features of Gynecologic Cancers in Taiwan -The HERGYN Study
This study looks at how common the HER2 protein is in patients with advanced endometrial, ovarian, and cervical cancers in Taiwan to better understand their cancer characteristics.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 510 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Daiichi Sankyo Taiwan Ltd. Industry-sponsored |
| Drugs / interventions | Trastuzumab |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06925113 on ClinicalTrials.gov |
What this trial studies
This observational study aims to retrospectively assess the prevalence of HER2 IHC 3+ in patients with recurrent advanced endometrial, ovarian, and cervical cancers in Taiwan. It will involve reviewing medical charts and collecting archived tissue samples from approximately 510 patients across five hospitals. The study will ensure consistency in HER2 scoring through a pathologist investigator meeting and will utilize the Ventana 4B5 assay for testing. The goal is to characterize the clinicopathologic features of these cancers and their HER2 expression.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with imaging or histological diagnoses of recurrent advanced endometrial, ovarian, or cervical cancers who have qualified tissue samples from 2022 to 2024.
Not a fit: Patients without recurrent advanced gynecologic cancers or those lacking qualified tissue samples from the specified timeframe may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of HER2 expression in gynecologic cancers, potentially leading to improved treatment options for patients.
How similar studies have performed: While this study is focused on a specific population in Taiwan, similar studies investigating HER2 prevalence in other cancers have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults aged ≥ 18 years when their clinical data are reviewed 2. Patients who fulfill ONE of the following criteria * Imaging or histological diagnosis of recurrent advanced endometrial cancer during 2022 to 2024, AND have tissue samples from recurrent advanced tumor (regardless of lines of received treatment) during 2022 to 2024 for HER2 IHC test (most recent and qualified pre-enrollment tumor sample must be provided) * Imaging or histological diagnosis of recurrent advanced ovarian cancer during 2022 to 2024, AND have tissue samples from recurrent advanced tumor (regardless of lines of received treatment) during 2022 to 2024 for HER2 IHC test (most recent and qualified pre-enrollment tumor sample must be provided) * Imaging or histological diagnosis of recurrent advanced cervical cancer during 2022 to 2024, AND have tissue samples from recurrent advanced tumor (regardless of lines of received treatment) during 2022 to 2024 for HER2 IHC test (most recent and qualified pre-enrollment tumor sample must be provided) Exclusion Criteria: 1. Without FFPE tumor sample from recurrent advanced tumors (specimens with limited tumor content and fine needle aspirates are inadequate for defining tumor HER2 status) 2. With the retrospective nature and the use of anonymous clinical data, IRB/IEC/EC may grant permission to waive informed consent in this study. If the informed consent is not waived, patients or representatives who are not willing to provide written informed consent cannot be enrolled.
Where this trial is running
Taipei
- Daiichi Sankyo Taiwan Ltd. — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Ellie Huang, Msc
- Email: ellie.huang@daiichisankyo.com
- Phone: +886-966-628328
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.