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Completed

NCT Number: NCT05165147

Analysis the Positive Rate of Tumor Markers Among Physical Examination Population

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.

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Key information

Conditions

Tumor Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. the positive rate of carcinoembryonic antigen（CEA）

    Time frame: 2019.01.01-2019.12.31

    The proportion of abnormal CEA in physical examination population was calculated. The range of normal value ： CEA≤5 ng/mL.

  2. the positive rate of α-fetoprotein（AFP）

    Time frame: 2019.01.01-2019.12.31

    The proportion of abnormal AFP in physical examination population was calculated. The range of normal value ： AFP≤20 ng/mL.

  3. the positive rate of carbohydrate antigen 19-9（CA 19-9）

    Time frame: 2019.01.01-2019.12.31

    The proportion of abnormal CA 19-9 in physical examination population was calculated. The range of normal value ： CA 19-9≤39 U/mL.

  4. the positive rate of carbohydrate antigen 125（CA 125）

    Time frame: 2019.01.01-2019.12.31

    The proportion of abnormal CA 125 in physical examination population was calculated. The range of normal value ： CA 125≤35 U/mL.

  5. the positive rate of carbohydrate antigen 72-4（CA 72-4）

    Time frame: 2019.01.01-2019.12.31

    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.

  6. the positive rate of carbohydrate antigen 15-3（CA 15-3）

    Time frame: 2019.01.01-2019.12.31

    The proportion of abnormal CA 15-3 in physical examination population was calculated. The range of normal value ： CA 15-3≤25 IU/mL.

  7. the positive rate of carbohydrate antigen 242（CA 242）

    Time frame: 2019.01.01-2019.12.31

    The proportion of abnormal CA 242 in physical examination population was calculated. The range of normal value ：CA 242≤20 U/mL.

  8. the positive rate of squamous cell carcinoma antigen（SCC）

    Time frame: 2019.01.01-2019.12.31

    The proportion of abnormal SCC in physical examination population was calculated. The range of normal value ：SCC≤1.5 ng/mL.

  9. the positive rate of Cytokeratin 19 fragment 21-1（CYFRA21-1）

    Time frame: 2019.01.01-2019.12.31

    The proportion of abnormal CYFRA21-1 in physical examination population was calculated. The range of normal value ：CYFRA21-1≤3.3 ng/mL.

  10. the positive rate of total prostate-specific antigen（ TPSA）

    Time frame: 2019.01.01-2019.12.31

    The proportion of abnormal TPSA in physical examination population was calculated. The range of normal value ：TPSA≤4 ng/mL.

  11. the positive rate of free prostate-specific antigen（ FPSA）

    Time frame: 2019.01.01-2019.12.31

    The proportion of abnormal FPSA in physical examination population was calculated. The range of normal value ：FPSA≤1 ng/mL.

  12. the positive rate of neuron specific enolase（ NSE）

    Time frame: 2019.01.01-2019.12.31

    The proportion of abnormal NSE in physical examination population was calculated. The range of normal value ：NSE≤17 ng/mL.

Secondary outcomes

  1. age

    Time frame: 2019.01.01-2019.12.31

    the age of physical examination population.

  2. the measured value of systolic blood pressure (SBP)

    Time frame: 2019.01.01-2019.12.31

    SBP measured on the day of physical examination.Unit of measure：mmHg

  3. the measured value of diastolic blood pressure (DBP)

    Time frame: 2019.01.01-2019.12.31

    DBP measured on the day of physical examination.Unit of measure：mmHg

  4. the measured value of fasting bood glucose (FBG)

    Time frame: 2019.01.01-2019.12.31

    FBG measured on the day of physical examination.Unit of measure：mmol/L

  5. the measured value of total cholesterol (TC)

    Time frame: 2019.01.01-2019.12.31

    TC measured on the day of physical examination.Unit of measure：mmol/L

  6. the measured value of Triglyceride (TG)

    Time frame: 2019.01.01-2019.12.31

    TG measured on the day of physical examination.Unit of measure：mmol/L

  7. the measured value of high density lipoprotein-cholesterol (HDL-C)

    Time frame: 2019.01.01-2019.12.31

    HDL-C measured on the day of physical examination.Unit of measure：mmol/L

  8. the measured value of low density lipoprotein-cholesterol (LDL-C)

    Time frame: 2019.01.01-2019.12.31

    LDL-C measured on the day of physical examination.Unit of measure：mmol/L

  9. the measured value of height

    Time frame: 2019.01.01-2019.12.31

    height measured on the day of physical examination.Unit of measure：cm

  10. the measured value of weight

    Time frame: 2019.01.01-2019.12.31

    height measured on the day of physical examination.Unit of measure：kg

  11. Body Mass Index (BMI)

    Time frame: 2019.01.01-2019.12.31

    weight and height will be combined to report BMI in kg/m^2

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2021
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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