Single Center Registration Study on HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer

NCT ID: NCT06146114

Last Updated: 2023-11-24

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-12-01

Brief Summary

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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

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1. 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.
2. (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:

1. The correlation between HER2 expression (IHC0/1+/2+/3+) and disease characteristics in locally advanced or metastatic prostate cancer patients;
2. 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

Conditions

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HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Collect HER2 expression in prostate cancer patients

Intervention Type DIAGNOSTIC_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

Interventions

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Collect HER2 expression in prostate cancer patients

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

\- 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Qilu hospital

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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yong wang, dcotor

Role: CONTACT

18560084850

Facility Contacts

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Benkang Shi

Role: primary

Other Identifiers

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bks03

Identifier Type: -

Identifier Source: org_study_id