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TumorNCT05165147

Analysis the Positive Rate of Tumor Markers Among Physical Examination Population

An observational study of Tumor, run by Peking University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Tumor
How many people
26,891 participants
Where
1 siteChina
Study dates
1 Jan 2019to 31 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Third Hospital

    Beijing, 100191

Other trials in China

About this study

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

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.

Read the detailed 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.

Conditions
Tumor
Being tested
no intervention
Keywords
physical examination population, tumor marker, TM
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no interventionOther

    no intervention

Study groups in NCT05165147
Study groupRoleWhat they receive
physical examination populationFrom January 2019 to December 2019, who underwent physical examination in Peking University Third Hospital were included in the study.
Receives: Other: no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2019.01.01-2019.12.31

  2. 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.

    Measured: 2019.01.01-2019.12.31

  3. 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.

    Measured: 2019.01.01-2019.12.31

  4. 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.

    Measured: 2019.01.01-2019.12.31

  5. 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.

    Measured: 2019.01.01-2019.12.31

  6. 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.

    Measured: 2019.01.01-2019.12.31

  7. 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.

    Measured: 2019.01.01-2019.12.31

  8. 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.

    Measured: 2019.01.01-2019.12.31

  9. 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.

    Measured: 2019.01.01-2019.12.31

  10. 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.

    Measured: 2019.01.01-2019.12.31

  11. 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.

    Measured: 2019.01.01-2019.12.31

  12. 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.

    Measured: 2019.01.01-2019.12.31

Secondary outcomes (11)

  1. age

    the age of physical examination population.

    Measured: 2019.01.01-2019.12.31

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

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

    Measured: 2019.01.01-2019.12.31

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

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

    Measured: 2019.01.01-2019.12.31

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

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

    Measured: 2019.01.01-2019.12.31

  5. the measured value of total cholesterol (TC)

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

    Measured: 2019.01.01-2019.12.31

  6. the measured value of Triglyceride (TG)

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

    Measured: 2019.01.01-2019.12.31

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

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

    Measured: 2019.01.01-2019.12.31

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

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

    Measured: 2019.01.01-2019.12.31

  9. the measured value of height

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

    Measured: 2019.01.01-2019.12.31

  10. the measured value of weight

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

    Measured: 2019.01.01-2019.12.31

  11. Body Mass Index (BMI)

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

    Measured: 2019.01.01-2019.12.31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2021
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
26,891 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05165147
Sponsor's protocol ID
IRB00006761-M2021321
Status last verified
Sep 2021
First submitted
20 Oct 2021
Last updated
21 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: no share

Publications

  • 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.

    PubMed 32294352

Questions about this trial

What is this clinical trial studying?

An observational study of Tumor, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the positive rate of carcinoembryonic antigen（CEA） (time frame: 2019.01.01-2019.12.31). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05165147, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.

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