Exploratory Study on HER2 Detection Method and Positive Threshold for High-grade Serous Adenocarcinoma of the Ovary
Ovarian cancer is the most lethal gynecological malignancy, and 70% of ovarian cancer patients are diagnosed late at the time of new diagnosis. Even after systematic treatment, 75% of patients still relapse within 3 years and 70% die within 5 years. The survival prognosis of platinum resistant and refractory ovarian cancer populations is currently an urgent issue that needs attention. Antibody drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) significantly improved the survival prognosis of patients with multiple solid tumors, such as breast cancer, gastric cancer, colorectal cancer, etc. Anti HER2 drugs have been a research hotspot in the treatment of advanced ovarian cancer in recent years. The expression status of HER2 has a decisive impact on the efficacy of ADC drugs targeting HER2. However, there is still a lack of large-scale data on HER2 expression rate in ovarian cancer patients, and there is no clear detection standard to guide clinical practice, which restricts the application of anti-HER2 ADC drugs in ovarian cancer.
To address this critical clinical issue, we initiated this study, which was divided into two parts: ① Retrospective study: Using the existing 144 samples of high-grade serous epithelial ovarian cancer(HGSOC) in our center, we used immunohistochemistry (IHC), DNA in situ hybridization (ISH), and second-generation sequencing (NGS) techniques to detect HER2 status, clarify the relationship between HER2 expression rate and patient survival outcomes, and preliminarily explore the best detection techniques and corresponding positive judgment thresholds for evaluating HER2 status in HGSOC; ② Real world observational study: To verify the predictive value of the positive judgment threshold determined in ① for efficacy in 20 ovarian cancer patients who received HER2 targeted ADC drugs due to platinum resistance/platinum refractory and no other effective treatment options in clinical practice. The aim of this project is to explore for the first time a reliable and feasible method for assessing the expression status of HER2 in patients with epithelial ovarian cancer, in order to provide a basis for subsequent evaluation of targeted HER2 therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China
- Recruiting
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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Contact:
- miaofang Wu
- Phone Number: +8613828494674
- Email: wmiaofang@mail.sysu.edu.cn
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Contact:
- Jing Li
- Phone Number: +8615915893493
- Email: lijing228@mail.sysu.edu.cn
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Principal Investigator:
- Jing Li, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pathological type: high-grade serous adenocarcinoma of the ovary
- Pathological slices stored within 5 years
- FIGO stage II or above
- Complete clinical and follow-up data
Exclusion Criteria:
- Slice quality control failure
- Incomplete follow-up data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Specimen with the diagnosis of high-grade serous ovarian adenocarcinoma within 5 years.
The International Federation of Gynecology and Obstetrics(FIGO) stage is II or above with complete follow-up data.
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Observational study without intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Exploratory study on HER 2 detection method and positive threshold for high-grade serous adenocarcinoma of the ovary
Time Frame: 2027-3-31
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Use multiple methods to detect the expression of HER 2 in HGSOC pathological specimens to find out the positive threshold of HGSOC patients then validate the threshold by observing the effectiveness of targeted HER2 ADC drugs in platinum resistant/refractory ovarian cancer patients in the real world
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2027-3-31
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSKY-2024-259-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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