Analysis the Positive Rate of Tumor Markers Among Physical Examination Population

NCT05165147 | Completed DMC

• 1 other identifier: IRB00006761-M2021321
• Study Type: observational
• Target: 26,891
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumor

Keywords

physical examination population; tumor marker; TM

Outcome Measures

Primary Outcomes (12)

• 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

• the positive rate of α-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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (11)

• age

  2019.01.01-2019.12.31

• the measured value of systolic blood pressure (SBP)

  2019.01.01-2019.12.31

• the measured value of diastolic blood pressure (DBP)

  2019.01.01-2019.12.31

• the measured value of fasting bood glucose (FBG)

  2019.01.01-2019.12.31

• the measured value of total cholesterol (TC)

  2019.01.01-2019.12.31

Study Arms (1)

physical examination population

From January 2019 to December 2019, who underwent physical examination in Peking University Third Hospital were included in the study.

Other: no intervention

Interventions

no intervention OTHER

no intervention

physical examination population

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

rom January 2019 to December 2019, who underwent physical examination in Peking University Third Hospital were included in the study.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

Related 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. No abstract available.

  PMID: 32294352 RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

• Wei Zhao, doctorate

  Peking University Third Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: December 21, 2021
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)