Analysis the Positive Rate of Tumor Markers Among Physical Examination Population

Tumor Clinical Trial

Official title:

Analysis the Positive Status of Tumor Markers Among Physical Examination Population in a Tertiary Grade A Class Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05165147
• Other study ID #: IRB00006761-M2021321
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To analyze the positive rate of tumor markers (TM) among health examination population in a tertiary grade A class hospital, compare the differences between different age and sex groups, and explore the possible influencing factors of TM positive.

Description:

From January 2019 to December 2019, who underwent physical examination in Peking University Third Hospital were included in the study. The expression levels of carcinoembryonic antigen (CEA),α-fetoprotein (AFP), carbohydrate antigen 19-9 (CA 19-9), carbohydrate antigen-125 (CA-125), carbohydrate antigen 72-4(CA 72-4), carbohydrate antigen 15-3 (CA 15-3), carbohydrate antigen 242(CA 242), squamous cell carcinoma antigen（SCC）, CYFRA21-1, total prostate-specific antigen (TPSA ) , free prostate-specific antigen(FPSA), neuron specific enolase(NSE) were detected by Electro chemistry luminescence method. The positive rates of TM were analyzed by descriptive statistical method Explore. The differences between different age and sex groups and the influencing factors were explored by statistic by Inferential statistical method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26891
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Those who have taken a physical examination and performed at least one TM test

Exclusion Criteria:

• Basic information is missing and cannot be retrieved
• The patient was diagnosed with malignant tumor before examination
• Those who have not done any TM tests

Related Conditions & MeSH terms

• Neoplasms
• Tumor

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Welch HG, Albertsen PC. Reconsidering Prostate Cancer Mortality - The Future of PSA Screening. N Engl J Med. 2020 Apr 16;382(16):1557-1563. doi: 10.1056/NEJMms1914228. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the positive rate of carcinoembryonic antigen(CEA)	The proportion of abnormal CEA in physical examination population was calculated. The range of normal value : CEA=5 ng/mL.	2019.01.01-2019.12.31
Primary	the positive rate of a-fetoprotein(AFP)	The proportion of abnormal AFP in physical examination population was calculated. The range of normal value : AFP=20 ng/mL.	2019.01.01-2019.12.31
Primary	the positive rate of carbohydrate antigen 19-9(CA 19-9)	The proportion of abnormal CA 19-9 in physical examination population was calculated. The range of normal value : CA 19-9=39 U/mL.	2019.01.01-2019.12.31
Primary	the positive rate of carbohydrate antigen 125(CA 125)	The proportion of abnormal CA 125 in physical examination population was calculated. The range of normal value : CA 125=35 U/mL.	2019.01.01-2019.12.31
Primary	the positive rate of carbohydrate antigen 72-4(CA 72-4)	The proportion of abnormal CA 72-4 in physical examination population was calculated. The range of normal value : CA 72-4=8.2 U/mL.	2019.01.01-2019.12.31
Primary	the positive rate of carbohydrate antigen 15-3(CA 15-3)	The proportion of abnormal CA 15-3 in physical examination population was calculated. The range of normal value : CA 15-3=25 IU/mL.	2019.01.01-2019.12.31
Primary	the positive rate of carbohydrate antigen 242(CA 242)	The proportion of abnormal CA 242 in physical examination population was calculated. The range of normal value :CA 242=20 U/mL.	2019.01.01-2019.12.31
Primary	the positive rate of squamous cell carcinoma antigen(SCC)	The proportion of abnormal SCC in physical examination population was calculated. The range of normal value :SCC=1.5 ng/mL.	2019.01.01-2019.12.31
Primary	the positive rate of Cytokeratin 19 fragment 21-1(CYFRA21-1)	The proportion of abnormal CYFRA21-1 in physical examination population was calculated. The range of normal value :CYFRA21-1=3.3 ng/mL.	2019.01.01-2019.12.31
Primary	the positive rate of total prostate-specific antigen( TPSA)	The proportion of abnormal TPSA in physical examination population was calculated. The range of normal value :TPSA=4 ng/mL.	2019.01.01-2019.12.31
Primary	the positive rate of free prostate-specific antigen( FPSA)	The proportion of abnormal FPSA in physical examination population was calculated. The range of normal value :FPSA=1 ng/mL.	2019.01.01-2019.12.31
Primary	the positive rate of neuron specific enolase( NSE)	The proportion of abnormal NSE in physical examination population was calculated. The range of normal value :NSE=17 ng/mL.	2019.01.01-2019.12.31
Secondary	age	the age of physical examination population.	2019.01.01-2019.12.31
Secondary	the measured value of systolic blood pressure (SBP)	SBP measured on the day of physical examination.Unit of measure:mmHg	2019.01.01-2019.12.31
Secondary	the measured value of diastolic blood pressure (DBP)	DBP measured on the day of physical examination.Unit of measure:mmHg	2019.01.01-2019.12.31
Secondary	the measured value of fasting bood glucose (FBG)	FBG measured on the day of physical examination.Unit of measure:mmol/L	2019.01.01-2019.12.31
Secondary	the measured value of total cholesterol (TC)	TC measured on the day of physical examination.Unit of measure:mmol/L	2019.01.01-2019.12.31
Secondary	the measured value of Triglyceride (TG)	TG measured on the day of physical examination.Unit of measure:mmol/L	2019.01.01-2019.12.31
Secondary	the measured value of high density lipoprotein-cholesterol (HDL-C)	HDL-C measured on the day of physical examination.Unit of measure:mmol/L	2019.01.01-2019.12.31
Secondary	the measured value of low density lipoprotein-cholesterol (LDL-C)	LDL-C measured on the day of physical examination.Unit of measure:mmol/L	2019.01.01-2019.12.31
Secondary	the measured value of height	height measured on the day of physical examination.Unit of measure:cm	2019.01.01-2019.12.31
Secondary	the measured value of weight	height measured on the day of physical examination.Unit of measure:kg	2019.01.01-2019.12.31
Secondary	Body Mass Index (BMI)	weight and height will be combined to report BMI in kg/m^2	2019.01.01-2019.12.31