Exploring HER2 Positive Diagnostic Criteria in High-grade Serous Ovarian CancerNCT06883487
Exploratory Study on HER2 Detection Method and Positive Threshold for High-grade Serous Adenocarcinoma of the Ovary
An observational study of Exploring HER2 Positive Diagnostic Criteria in High-grade Serous Ovarian Cancer and Observing the Effectiveness of Targeted HER2 ADC Drugs, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Exploring HER2 Positive Diagnostic Criteria in High-grade Serous Ovarian Cancer, Observing the Effectiveness of Targeted HER2 ADC Drugs
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2024to 31 Mar 2027
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pathological specimen stored by the department of pathology in Sun Yat-sen Memorial Hospital with a clinical diagnosis of FIGO stage II or above and complete survival data
Who may be able to join
- 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
Who cannot join
- Slice quality control failure
- Incomplete follow-up data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
Jing Li, +8615915893493, lijing228@mail.sysu.edu.cn
miaofang Wu, +8613828494674, wmiaofang@mail.sysu.edu.cn
About this study
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.
- Conditions
- Exploring HER2 Positive Diagnostic Criteria in High-grade Serous Ovarian Cancer, Observing the Effectiveness of Targeted HER2 ADC Drugs
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study without intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory study on HER 2 detection method and positive threshold for high-grade serous adenocarcinoma of the ovary
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
Measured: 2027-3-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start7 Apr 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exploring HER2 Positive Diagnostic Criteria in High-grade Serous Ovarian CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Li, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883487
- Sponsor's protocol ID
- SYSKY-2024-259-01
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on HER2 Detection Method and Positive Threshold for High-grade Serous Adenocarcinoma of the Ovary
- ClinicalTrials.gov ID
- NCT06883487
- Acronym / sponsor ID
- SYSKY-2024-259-01
- Conditions
- Exploring HER2 Positive Diagnostic Criteria in High-grade Serous Ovarian Cancer, Observing the Effectiveness of Targeted HER2 ADC Drugs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 19 Mar 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: No interventionSpecimen 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathological specimen stored by the department of pathology in Sun Yat-sen Memorial Hospital with a clinical diagnosis of FIGO stage II or above and complete survival data
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Slice quality control failure
- Incomplete follow-up data
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 |
|---|---|---|
| No interventionObservational study without intervention | Other | 1 |
Primary outcome
Exploratory study on HER 2 detection method and positive threshold for high-grade serous adenocarcinoma of the ovary
Time frame: 2027-3-31
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
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 19 Mar 2025.
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.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, China
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 Exploring HER2 Positive Diagnostic Criteria in High-grade Serous Ovarian Cancer and Observing the Effectiveness of Targeted HER2 ADC Drugs, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 2 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 19 Mar 2025. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory study on HER 2 detection method and positive threshold for high-grade serous adenocarcinoma of the ovary (time frame: 2027-3-31). 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 19 Mar 2025.