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Trial Title:
Single Center Registration Study on HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer
NCT ID:
NCT06146114
Condition:
HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
HER2
prostate cancer
clinical pathological characteristics
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Collect HER2 expression in prostate cancer patients
Description:
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
Arm group label:
experimental group
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.
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
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Male
Minimum age:
50 Years
Maximum age:
90 Years
Locations:
Facility:
Name:
Qilu hospital
Address:
City:
Jinan
Zip:
276600
Country:
China
Status:
Recruiting
Contact:
Last name:
Benkang Shi
Phone:
bkang68@sdu.edu.cn
Email:
bkang68@sdu.edu.cn
Start date:
July 1, 2023
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06146114
