HER2 Expression and Clinical Pathological Characteristics in Prostate CancerNCT06146114
Single Center Registration Study on HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer
An observational study of HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This study is a single center, non-interference, retrospective registration study: HER2 testing and disease information collection were conducted on patients diagnosed with prostate cancer and able to obtain tumor tissue in our hospital from January 2018 to July 2023. Read more about this study
- Who is it for?
- Ages 50 to 90 years, men only
- Conditions the study is for
- HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer
- What is being tested?
- Collect HER2 expression in prostate cancer patients
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 90 years
- Men only
- Adult, Older adult
Study population: HER2 testing and disease information collection for patients diagnosed with prostate cancer and able to obtain tumor tissue in our hospital from January 2018 to July 2023
Who may be able to join
- 1. Prostate cancer patients confirmed by histopathology in our hospital from January 2018 to July 2023;
- 2. Men aged ≥ 18 years old;
- 3. The expected survival time is greater than 12 weeks;
- 4. The KPS functional status score is greater than 60, and the ECOG status score is 0-2 points;
- 5. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Who cannot join
- 1. Those who have been diagnosed with tumors in other parts, such as lung cancer, liver cancer, stomach cancer, colorectal cancer, breast cancer, etc. (except for cancer in situ or non melanoma skin cancer, or combined tumors with low recurrence probability within a few years);
- 2. According to the researcher's judgment, there are other patients who are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu hospital
Jinan, Shandong, 276600
Benkang Shi, bkang68@sdu.edu.cn, bkang68@sdu.edu.cn
About this study
Official title: Single Center Registration Study on HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer.
This study is a single center, non-interference, retrospective registration study: HER2 testing and disease information collection were conducted on patients diagnosed with prostate cancer and able to obtain tumor tissue in our hospital from January 2018 to July 2023. Statistical analysis was conducted on the collected information to analyze the expression of HER2 in Chinese prostate patients and the correlation between HER2 and disease type.
Read the detailed description
- To explore the expression of HER2 protein in prostate cancer patients admitted to Qilu Hospital of Shandong University, especially the expression rate of HER2 protein under different pathological characteristics (age, TNM grade, primary and metastasis), and to explore the correlation between HER2 protein expression level, efficacy, and prognosis based on patient clinical information.
- (1) Main Purpose
Analyze the expression of HER2 in prostate cancer patients admitted to Qilu Hospital of Shandong University.
(2) Secondary purpose
The expression of HER2 protein under different clinical and pathological characteristics (age, TNM grade, primary, and metastasis).
3.Main indicators:
The expression of HER2 in prostate cancer patients.
Secondary indicators:
- The correlation between HER2 expression (IHC0/1+/2+/3+) and disease characteristics in locally advanced or metastatic prostate cancer patients;
- The distribution of HER2 expression in different ages, different parts, different degrees of differentiation, and different TNM stages; Evaluate the expression of primary and metastatic lesions in patients with metastasis
- Being tested
- Collect HER2 expression in prostate cancer patients
- Keywords
- HER2, prostate cancer, clinical pathological characteristics
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect HER2 expression in prostate cancer patientsDiagnostic test
HER2 testing and disease information collection for patients diagnosed with prostate cancer and able to obtain tumor tissue in our hospital from January 2018 to July 2023
| Study group | Role | What they receive |
|---|---|---|
| experimental group | 1. Prostate cancer patients confirmed by histopathology in our hospital from January 2018 to July 2023;
2. Men aged ≥ 18 years old;
3. The expected survival time is greater than 12 weeks;
4. The KPS functional status score is greater than 60, and the ECOG status score is 0-2 points;
5. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up. Receives: Diagnostic Test: Collect HER2 expression in prostate cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
HER2 expression in prostate cancer patients
HER2 test results
Measured: 18 months
Secondary outcomes (2)
Correlation between HER2 expression (IHC0/1+/2+/3+) and disease characteristics in locally advanced or metastatic prostate cancer patients
Measured: 18 months
The distribution of HER2 expression in different ages, different parts, different degrees of differentiation, and different TNM stages;
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Jul 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Expression and Clinical Pathological Characteristics in Prostate 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146114
- Sponsor's protocol ID
- bks03
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Registration Study on HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer.
- ClinicalTrials.gov ID
- NCT06146114
- Acronym / sponsor ID
- bks03
- Keywords
- HER2, prostate cancer, clinical pathological characteristics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Nov 2023 (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.
This study is a single center, non-interference, retrospective registration study: HER2 testing and disease information collection were conducted on patients diagnosed with prostate cancer and able to obtain tumor tissue in our hospital from January 2018 to July 2023. Statistical analysis was conducted on the collected information to analyze the expression of HER2 in Chinese prostate patients and the correlation between HER2 and disease type.
Detailed description
- To explore the expression of HER2 protein in prostate cancer patients admitted to Qilu Hospital of Shandong University, especially the expression rate of HER2 protein under different pathological characteristics (age, TNM grade, primary and metastasis), and to explore the correlation between HER2 protein expression level, efficacy, and prognosis based on patient clinical information.
- (1) Main Purpose
Analyze the expression of HER2 in prostate cancer patients admitted to Qilu Hospital of Shandong University.
(2) Secondary purpose
The expression of HER2 protein under different clinical and pathological characteristics (age, TNM grade, primary, and metastasis).
3.Main indicators:
The expression of HER2 in prostate cancer patients.
Secondary indicators:
- The correlation between HER2 expression (IHC0/1+/2+/3+) and disease characteristics in locally advanced or metastatic prostate cancer patients;
- The distribution of HER2 expression in different ages, different parts, different degrees of differentiation, and different TNM stages; Evaluate the expression of primary and metastatic lesions in patients with metastasis
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Diagnostic Test: Collect HER2 expression in prostate cancer patients1. Prostate cancer patients confirmed by histopathology in our hospital from January 2018 to July 2023; 2. Men aged ≥ 18 years old; 3. The expected survival time is greater than 12 weeks; 4. The KPS functional status score is greater than 60, and the ECOG status score is 0-2 points; 5. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- HER2 testing and disease information collection for patients diagnosed with prostate cancer and able to obtain tumor tissue in our hospital from January 2018 to July 2023
Key inclusion criteria (5 listed)
- 1. Prostate cancer patients confirmed by histopathology in our hospital from January 2018 to July 2023;
- 2. Men aged ≥ 18 years old;
- 3. The expected survival time is greater than 12 weeks;
- 4. The KPS functional status score is greater than 60, and the ECOG status score is 0-2 points;
- 5. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Key exclusion criteria (2 listed)
- 1. Those who have been diagnosed with tumors in other parts, such as lung cancer, liver cancer, stomach cancer, colorectal cancer, breast cancer, etc. (except for cancer in situ or non melanoma skin cancer, or combined tumors with low recurrence probability within a few years);
- 2. According to the researcher's judgment, there are other patients who are not suitable for inclusion.
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 |
|---|---|---|
| Collect HER2 expression in prostate cancer patientsHER2 testing and disease information collection for patients diagnosed with prostate cancer and able to obtain tumor tissue in our hospital from January 2018 to July 2023 | Diagnostic test | experimental group |
Primary outcome
HER2 expression in prostate cancer patients
Time frame: 18 months
HER2 test results
2 secondary outcomes
Correlation between HER2 expression (IHC0/1+/2+/3+) and disease characteristics in locally advanced or metastatic prostate cancer patients
Time frame: 18 months
The distribution of HER2 expression in different ages, different parts, different degrees of differentiation, and different TNM stages;
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
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 HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer, run by Qilu Hospital of Shandong 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 5 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: status not confirmed, as of the sponsor's last update on 24 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yong wang, dcotor (18560084850, bkang68@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HER2 expression in prostate cancer patients (time frame: 18 months). 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 24 Nov 2023.