ID

22202

Beskrivning

Protein Biomarker in Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00465842

Länk

https://clinicaltrials.gov/show/NCT00465842

Nyckelord

Versioner (1)
  1. 2017-05-22 2017-05-22 -
Uppladdad den

22 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Normal Volunteers NCT00465842

Engelsk

Eligibility Normal Volunteers NCT00465842

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
group a: normal volunteers without any history of liver disease and with normal liver functions test (lft), including total protein/albumin, ldh, alt, ast, ggt, total bilirubin, direct and indirect bilirubin and do not belong to group b. volunteers will be screened using questionnaires. those deemed suitable will then be asked to have the blood test done. all blood tests are done free of charge to subjects.
Beskrivning

Normal Volunteers | Liver diseases Absent | Liver function tests normal | albumin/protein.total | Lactate dehydrogenase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Gamma glutamyl transferase measurement | Serum total bilirubin measurement | Bilirubin, direct measurement | Indirect Bilirubin Measurement | screening questionnaire | Hematologic Tests

Datatyp

boolean

Alias
UMLS CUI [1]
C3661466
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0438235
UMLS CUI [4]
C0805031
UMLS CUI [5]
C0202113
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201899
UMLS CUI [8]
C0202035
UMLS CUI [9]
C1278039
UMLS CUI [10]
C0201916
UMLS CUI [11]
C1881193
UMLS CUI [12]
C1134635
UMLS CUI [13]
C0018941
group b: hepatitis b or c carriers with normal liver functions.
Beskrivning

Hepatitis B carrier | Hepatitis C carrier | Liver function

Datatyp

boolean

Alias
UMLS CUI [1]
C0262505
UMLS CUI [2]
C0400920
UMLS CUI [3]
C0232741
group c: hepatitis b or c carriers with abnormal liver functions.
Beskrivning

Hepatitis B carrier | Hepatitis C carrier | Liver Dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0262505
UMLS CUI [2]
C0400920
UMLS CUI [3]
C0086565
group d: liver cirrhosis, proven by liver biopsy or on clinical evidences, such as varices on ct scan indicative of portal hypertension.
Beskrivning

Liver Cirrhosis Biopsy of liver | Liver Cirrhosis Evidence of | Varices X-Ray Computed Tomography | Indication of Portal Hypertension

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0332120
UMLS CUI [3,1]
C0042345
UMLS CUI [3,2]
C0040405
UMLS CUI [4,1]
C0392360
UMLS CUI [4,2]
C0020541
group e: hcc patients with resection.
Beskrivning

Liver carcinoma | Excision

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0728940
group f: unresectable hcc patients with treatment.
Beskrivning

Liver carcinoma unresectable | Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1519810
UMLS CUI [2]
C0087111
group g: hcc patients with active malignant disease and only palliative care are offered.
Beskrivning

Liver carcinoma | Malignant Neoplasm | Palliative Care

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0030231
signed informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
≥ 18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
in this trial, diagnosis of hcc is established with either (a) known hepatitis b or c carrier, and space occupying lesion(s) in the liver and afp > 400ng/ml or (b) cytological or histological confirmation by biopsy
Beskrivning

Liver carcinoma | Hepatitis B carrier | Hepatitis C carrier | Space occupying lesion of liver | Alpha one fetoprotein measurement | Biopsy

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0262505
UMLS CUI [3]
C0400920
UMLS CUI [4]
C0579131
UMLS CUI [5]
C0201539
UMLS CUI [6]
C0005558
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
there is no exclusion criteria
Beskrivning

Unspecified

Datatyp

boolean

Alias
UMLS CUI [1]
C0205370
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Similar models

Eligibility Normal Volunteers NCT00465842

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Normal Volunteers | Liver diseases Absent | Liver function tests normal | albumin/protein.total | Lactate dehydrogenase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Gamma glutamyl transferase measurement | Serum total bilirubin measurement | Bilirubin, direct measurement | Indirect Bilirubin Measurement | screening questionnaire | Hematologic Tests
Item
group a: normal volunteers without any history of liver disease and with normal liver functions test (lft), including total protein/albumin, ldh, alt, ast, ggt, total bilirubin, direct and indirect bilirubin and do not belong to group b. volunteers will be screened using questionnaires. those deemed suitable will then be asked to have the blood test done. all blood tests are done free of charge to subjects.
boolean
C3661466 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0438235 (UMLS CUI [3])
C0805031 (UMLS CUI [4])
C0202113 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0202035 (UMLS CUI [8])
C1278039 (UMLS CUI [9])
C0201916 (UMLS CUI [10])
C1881193 (UMLS CUI [11])
C1134635 (UMLS CUI [12])
C0018941 (UMLS CUI [13])
Hepatitis B carrier | Hepatitis C carrier | Liver function
Item
group b: hepatitis b or c carriers with normal liver functions.
boolean
C0262505 (UMLS CUI [1])
C0400920 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Hepatitis B carrier | Hepatitis C carrier | Liver Dysfunction
Item
group c: hepatitis b or c carriers with abnormal liver functions.
boolean
C0262505 (UMLS CUI [1])
C0400920 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
Liver Cirrhosis Biopsy of liver | Liver Cirrhosis Evidence of | Varices X-Ray Computed Tomography | Indication of Portal Hypertension
Item
group d: liver cirrhosis, proven by liver biopsy or on clinical evidences, such as varices on ct scan indicative of portal hypertension.
boolean
C0023890 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0042345 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C0392360 (UMLS CUI [4,1])
C0020541 (UMLS CUI [4,2])
Liver carcinoma | Excision
Item
group e: hcc patients with resection.
boolean
C2239176 (UMLS CUI [1])
C0728940 (UMLS CUI [2])
Liver carcinoma unresectable | Therapeutic procedure
Item
group f: unresectable hcc patients with treatment.
boolean
C2239176 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
Liver carcinoma | Malignant Neoplasm | Palliative Care
Item
group g: hcc patients with active malignant disease and only palliative care are offered.
boolean
C2239176 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0030231 (UMLS CUI [3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Liver carcinoma | Hepatitis B carrier | Hepatitis C carrier | Space occupying lesion of liver | Alpha one fetoprotein measurement | Biopsy
Item
in this trial, diagnosis of hcc is established with either (a) known hepatitis b or c carrier, and space occupying lesion(s) in the liver and afp > 400ng/ml or (b) cytological or histological confirmation by biopsy
boolean
C2239176 (UMLS CUI [1])
C0262505 (UMLS CUI [2])
C0400920 (UMLS CUI [3])
C0579131 (UMLS CUI [4])
C0201539 (UMLS CUI [5])
C0005558 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Unspecified
Item
there is no exclusion criteria
boolean
C0205370 (UMLS CUI [1])
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