- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05165147
Analysis the Positive Rate of Tumor Markers Among Physical Examination Population
6. december 2021 opdateret af: Peking University Third Hospital
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
26891
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beijing, Kina, 100191
- Peking University Third Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
rom January 2019 to December 2019, who underwent physical examination in Peking University Third Hospital were included in the study.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
physical examination population
From January 2019 to December 2019, who underwent physical examination in Peking University Third Hospital were included in the study.
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intet indgreb
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
the positive rate of carcinoembryonic antigen(CEA)
Tidsramme: 2019.01.01-2019.12.31
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The proportion of abnormal CEA in physical examination population was calculated.
The range of normal value : CEA≤5 ng/mL.
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2019.01.01-2019.12.31
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the positive rate of α-fetoprotein(AFP)
Tidsramme: 2019.01.01-2019.12.31
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The proportion of abnormal AFP in physical examination population was calculated.
The range of normal value : AFP≤20 ng/mL.
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2019.01.01-2019.12.31
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the positive rate of carbohydrate antigen 19-9(CA 19-9)
Tidsramme: 2019.01.01-2019.12.31
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The proportion of abnormal CA 19-9 in physical examination population was calculated.
The range of normal value : CA 19-9≤39 U/mL.
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2019.01.01-2019.12.31
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the positive rate of carbohydrate antigen 125(CA 125)
Tidsramme: 2019.01.01-2019.12.31
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The proportion of abnormal CA 125 in physical examination population was calculated.
The range of normal value : CA 125≤35 U/mL.
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2019.01.01-2019.12.31
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the positive rate of carbohydrate antigen 72-4(CA 72-4)
Tidsramme: 2019.01.01-2019.12.31
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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.
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2019.01.01-2019.12.31
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the positive rate of carbohydrate antigen 15-3(CA 15-3)
Tidsramme: 2019.01.01-2019.12.31
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The proportion of abnormal CA 15-3 in physical examination population was calculated.
The range of normal value : CA 15-3≤25 IU/mL.
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2019.01.01-2019.12.31
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the positive rate of carbohydrate antigen 242(CA 242)
Tidsramme: 2019.01.01-2019.12.31
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The proportion of abnormal CA 242 in physical examination population was calculated.
The range of normal value :CA 242≤20 U/mL.
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2019.01.01-2019.12.31
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the positive rate of squamous cell carcinoma antigen(SCC)
Tidsramme: 2019.01.01-2019.12.31
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The proportion of abnormal SCC in physical examination population was calculated.
The range of normal value :SCC≤1.5 ng/mL.
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2019.01.01-2019.12.31
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the positive rate of Cytokeratin 19 fragment 21-1(CYFRA21-1)
Tidsramme: 2019.01.01-2019.12.31
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The proportion of abnormal CYFRA21-1 in physical examination population was calculated.
The range of normal value :CYFRA21-1≤3.3
ng/mL.
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2019.01.01-2019.12.31
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the positive rate of total prostate-specific antigen( TPSA)
Tidsramme: 2019.01.01-2019.12.31
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The proportion of abnormal TPSA in physical examination population was calculated.
The range of normal value :TPSA≤4 ng/mL.
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2019.01.01-2019.12.31
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the positive rate of free prostate-specific antigen( FPSA)
Tidsramme: 2019.01.01-2019.12.31
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The proportion of abnormal FPSA in physical examination population was calculated.
The range of normal value :FPSA≤1 ng/mL.
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2019.01.01-2019.12.31
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the positive rate of neuron specific enolase( NSE)
Tidsramme: 2019.01.01-2019.12.31
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The proportion of abnormal NSE in physical examination population was calculated.
The range of normal value :NSE≤17 ng/mL.
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2019.01.01-2019.12.31
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
age
Tidsramme: 2019.01.01-2019.12.31
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the age of physical examination population.
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2019.01.01-2019.12.31
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the measured value of systolic blood pressure (SBP)
Tidsramme: 2019.01.01-2019.12.31
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SBP measured on the day of physical examination.Unit of measure:mmHg
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2019.01.01-2019.12.31
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the measured value of diastolic blood pressure (DBP)
Tidsramme: 2019.01.01-2019.12.31
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DBP measured on the day of physical examination.Unit of measure:mmHg
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2019.01.01-2019.12.31
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the measured value of fasting bood glucose (FBG)
Tidsramme: 2019.01.01-2019.12.31
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FBG measured on the day of physical examination.Unit of measure:mmol/L
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2019.01.01-2019.12.31
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the measured value of total cholesterol (TC)
Tidsramme: 2019.01.01-2019.12.31
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TC measured on the day of physical examination.Unit of measure:mmol/L
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2019.01.01-2019.12.31
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the measured value of Triglyceride (TG)
Tidsramme: 2019.01.01-2019.12.31
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TG measured on the day of physical examination.Unit of measure:mmol/L
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2019.01.01-2019.12.31
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the measured value of high density lipoprotein-cholesterol (HDL-C)
Tidsramme: 2019.01.01-2019.12.31
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HDL-C measured on the day of physical examination.Unit of measure:mmol/L
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2019.01.01-2019.12.31
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the measured value of low density lipoprotein-cholesterol (LDL-C)
Tidsramme: 2019.01.01-2019.12.31
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LDL-C measured on the day of physical examination.Unit of measure:mmol/L
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2019.01.01-2019.12.31
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the measured value of height
Tidsramme: 2019.01.01-2019.12.31
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height measured on the day of physical examination.Unit of measure:cm
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2019.01.01-2019.12.31
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the measured value of weight
Tidsramme: 2019.01.01-2019.12.31
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height measured on the day of physical examination.Unit of measure:kg
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2019.01.01-2019.12.31
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Body Mass Index (BMI)
Tidsramme: 2019.01.01-2019.12.31
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weight and height will be combined to report BMI in kg/m^2
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2019.01.01-2019.12.31
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Wei Zhao, doctorate, Peking University Third Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2019
Primær færdiggørelse (Faktiske)
31. december 2019
Studieafslutning (Faktiske)
31. december 2019
Datoer for studieregistrering
Først indsendt
20. oktober 2021
Først indsendt, der opfyldte QC-kriterier
6. december 2021
Først opslået (Faktiske)
21. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. december 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. december 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00006761-M2021321
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
no share
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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