Exploratory Study on HER2 Detection Method and Positive Threshold for High-grade Serous Adenocarcinoma of the Ovary
NCT ID: NCT06883487
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
144 participants
OBSERVATIONAL
2024-04-07
2027-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
No intervention
Observational study without intervention
Interventions
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No intervention
Observational study without intervention
Eligibility Criteria
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Inclusion Criteria
2. Pathological slices stored within 5 years
3. FIGO stage II or above
4. Complete clinical and follow-up data
Exclusion Criteria
2. Incomplete follow-up data
18 Years
75 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Jing Li
vice-professor
Locations
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Countries
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Facility Contacts
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Other Identifiers
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SYSKY-2024-259-01
Identifier Type: -
Identifier Source: org_study_id
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