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

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06146114
Collaborator
(none)
100
Enrollment
1
Location
17.1
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Collect HER2 expression in prostate cancer patients

Detailed Description

  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

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Single Center Registration Study on HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer.
Actual Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
experimental group

Prostate cancer patients confirmed by histopathology in our hospital from January 2018 to July 2023; Men aged ≥ 18 years old; The expected survival time is greater than 12 weeks; The KPS functional status score is greater than 60, and the ECOG status score is 0-2 points; The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Diagnostic Test: 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

Outcome Measures

Primary Outcome Measures

  1. HER2 expression in prostate cancer patients [18 months]

    HER2 test results

Secondary Outcome Measures

  1. Correlation between HER2 expression (IHC0/1+/2+/3+) and disease characteristics in locally advanced or metastatic prostate cancer patients [18 months]

  2. The distribution of HER2 expression in different ages, different parts, different degrees of differentiation, and different TNM stages; [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
Male
Inclusion Criteria:
    1. Prostate cancer patients confirmed by histopathology in our hospital from January 2018 to July 2023;

  1. Men aged ≥ 18 years old;

  2. The expected survival time is greater than 12 weeks;

  3. The KPS functional status score is greater than 60, and the ECOG status score is 0-2 points;

  4. 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);
  1. According to the researcher's judgment, there are other patients who are not suitable for inclusion.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qilu hospital Jinan Shandong China 276600

Sponsors and Collaborators

  • Qilu Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier:
NCT06146114
Other Study ID Numbers:
  • bks03
First Posted:
Nov 24, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Qilu Hospital of Shandong University
HER2
prostate cancer
clinical pathological characteristics
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Nov 24, 2023