ID

28117

Beschreibung

Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01798173

Link

https://clinicaltrials.gov/show/NCT01798173

Stichworte

Versionen (1)
  1. 19.12.17 19.12.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

19. Dezember 2017

DOI

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Eligibility Cirrhosis With Hepatocellular Carcinoma NCT01798173

Englisch

Eligibility Cirrhosis With Hepatocellular Carcinoma NCT01798173

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
cases and controls will be males and females aged 35 or older, and will give an informed consent to participate in the study.
Beschreibung

Age | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
* hepatocellular carcinoma case:
Beschreibung

Liver carcinoma Case

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1706256
all hepatocellular carcinoma cases evolving in cirrhotic liver, whatever the etiology of cirrhosis, will be included. criteria for the diagnosis of hepatocellular carcinoma will be those defined by the european association for study of the liver (easl) (bruix j, j hepatol 2001):
Beschreibung

Liver carcinoma Evolving Liver Cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0332253
UMLS CUI [1,3]
C0023890
focal hepatic lesions ≥ 2cm in diameter:
Beschreibung

Lesion of liver Focal Diameter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C1301886
alpha-fetoprotein (afp) < 400 ng/ml: nodules have to be identified by at least two coincident morphologic examinations (abdominal us, angiography, ct or mri) with arterial hypervascularisation in at least one of the imaging modalities
Beschreibung

Alpha-fetoprotein measurement | Nodule Identification | Examination morphological Quantity | Abdominal Ultrasound | Abdominal angiography | CT of abdomen | MRI of abdomen | Arterial Hypervascularization

Datentyp

boolean

Alias
UMLS CUI [1]
C0201539
UMLS CUI [2,1]
C0028259
UMLS CUI [2,2]
C0205396
UMLS CUI [3,1]
C0582103
UMLS CUI [3,2]
C0543482
UMLS CUI [3,3]
C1265611
UMLS CUI [4]
C2348813
UMLS CUI [5]
C0412251
UMLS CUI [6]
C0412620
UMLS CUI [7]
C0412693
UMLS CUI [8]
C3831472
afp > 400 ng/ml: lesion seen in a single imaging modality
Beschreibung

Alpha-fetoprotein measurement | Lesion seen Imaging

Datentyp

boolean

Alias
UMLS CUI [1]
C0201539
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0205397
UMLS CUI [2,3]
C0079595
focal hepatic lesions < 2 cm in diameter:
Beschreibung

Lesion of liver Focal Diameter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C1301886
lesions 1 to 2 cm in diameter:use of fine-needle aspiration with biopsy
Beschreibung

Lesion Diameter Fine needle aspiration biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C1510483
lesions < 1 cm: serial abdominal us every 3 months until the lesion exceeds 1 cm in size so that biopsy becomes possible. such cases will be included after diagnosis confirmation.
Beschreibung

Lesion Diameter Abdominal Ultrasound Series

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C2348813
UMLS CUI [1,4]
C0205549
whatever the size of focal lesions, the diagnosis of cirrhosis will be made according to the same criteria as in the cirrhotic group control.
Beschreibung

Lesion Focal Size | Liver Cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0456389
UMLS CUI [2]
C0023890
* cirrhotic control patients:
Beschreibung

Patients Cirrhotic Control Group

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0439686
UMLS CUI [1,3]
C0009932
all patients with cirrhosis, whatever its etiology, will be included. the diagnosis of cirrhosis will rely on:
Beschreibung

Liver Cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0023890
histological confirmation by liver biopsy or in the absence of biopsy:
Beschreibung

Biopsy of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0193388
in patients free of portal thrombosis at doppler imaging, on the presence of portal hypertension ascertained by biological (tricytopenia), morphologic (abdominal us, ct or mri), hepatic venous pressure measurement or upper endoscopy (mosaic gastropathy, varices).
Beschreibung

Portal vein thrombosis Free of Doppler Ultrasound Imaging | Portal Hypertension Biological measurement | Pancytopenia | Portal Hypertension Measurement morphological | Abdominal Ultrasound | CT of abdomen | MRI of abdomen | Portal Hypertension Hepatic venous pressure gradient | Endoscopy of stomach | Portal hypertensive gastropathy | Gastric Varices

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0155773
UMLS CUI [1,2]
C0332296
UMLS CUI [1,3]
C2713308
UMLS CUI [2,1]
C0020541
UMLS CUI [2,2]
C0814047
UMLS CUI [3]
C0030312
UMLS CUI [4,1]
C0020541
UMLS CUI [4,2]
C0242485
UMLS CUI [4,3]
C0543482
UMLS CUI [5]
C2348813
UMLS CUI [6]
C0412620
UMLS CUI [7]
C0412693
UMLS CUI [8,1]
C0020541
UMLS CUI [8,2]
C4049263
UMLS CUI [9]
C0017195
UMLS CUI [10]
C0580174
UMLS CUI [11]
C0017145
in patients with portal thrombosis, on the presence of portal hypertension associated with: clinical (hepatomegaly with clinical evidence of hepatocellular failure: spider naevi, palmar erythema, white mails, gynecomastia) or morphological signs of cirrhosis (enlarged liver, nodular surface, sharp lower edge).
Beschreibung

Portal vein thrombosis | Portal Hypertension Associated with Sign or Symptom Liver Cirrhosis | Hepatomegaly Associated with Liver Failure | Spider nevus | Palmar erythema | Other Coding | Gynecomastia | Portal Hypertension Associated with Signs morphological Liver Cirrhosis | Hepatomegaly | Surface Nodular | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1]
C0155773
UMLS CUI [2,1]
C0020541
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C3540840
UMLS CUI [2,4]
C0023890
UMLS CUI [3,1]
C0019209
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0085605
UMLS CUI [4]
C0085666
UMLS CUI [5]
C0014745
UMLS CUI [6]
C3846158
UMLS CUI [7]
C0018418
UMLS CUI [8,1]
C0020541
UMLS CUI [8,2]
C0332281
UMLS CUI [8,3]
C0220912
UMLS CUI [8,4]
C0543482
UMLS CUI [8,5]
C0023890
UMLS CUI [9]
C0019209
UMLS CUI [10,1]
C0205148
UMLS CUI [10,2]
C0205297
UMLS CUI [11]
C3846158
and/or biological signs of hepatocellular failure (tp<70%, low albuminemia) and/or sinusoidal block assessed by liver venous gradient > 18mmhg in the present state of knowledge, a fibrotest value at 4 or a fibroscan value > 12.5 kilopascal.
Beschreibung

Signs biological Liver Failure | Total protein measurement | Blood albumin decreased | Sinusoid Obstruction | Hepatic venous pressure gradient | FibroTest Score Measurement | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220912
UMLS CUI [1,2]
C0205460
UMLS CUI [1,3]
C0085605
UMLS CUI [2]
C0555903
UMLS CUI [3]
C0853777
UMLS CUI [4,1]
C0682624
UMLS CUI [4,2]
C0028778
UMLS CUI [5]
C4049263
UMLS CUI [6]
C3642160
UMLS CUI [7]
C3846158
without any other clinical or biological signs will be considered as diagnosis criteria of cirrhosis only for chronic viral c hepatitis.
Beschreibung

Liver Cirrhosis | Hepatitis C, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0524910
the lack of hepatocellular carcinoma in cirrhotic patients at inclusion will be assessed through good quality imaging examinations (abdominal us, ct scan or mri) and afp below 100 ng/ml.
Beschreibung

Patients Cirrhotic | Liver carcinoma Lacking | Imaging | Abdominal Ultrasound | CT of abdomen | MRI of abdomen | Alpha-fetoprotein measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0439686
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0332268
UMLS CUI [3]
C0079595
UMLS CUI [4]
C2348813
UMLS CUI [5]
C0412620
UMLS CUI [6]
C0412693
UMLS CUI [7]
C0201539
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
age under 35 of year
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
other cancer in evolution
Beschreibung

Cancer Other Evolving

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332253
hiv infection
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
major somatic pr psychiatric illness not compatible with the inclusion in the study
Beschreibung

Mental disorders Prevalence Somatic Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0220900
UMLS CUI [1,3]
C2986476
UMLS CUI [1,4]
C0205164
no hepatocellular carcinoma primary liver cancer.
Beschreibung

Cancer Other | Exception Liver carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2239176
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Ähnliche Modelle

Eligibility Cirrhosis With Hepatocellular Carcinoma NCT01798173

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
cases and controls will be males and females aged 35 or older, and will give an informed consent to participate in the study.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Liver carcinoma Case
Item
* hepatocellular carcinoma case:
boolean
C2239176 (UMLS CUI [1,1])
C1706256 (UMLS CUI [1,2])
Liver carcinoma Evolving Liver Cirrhosis
Item
all hepatocellular carcinoma cases evolving in cirrhotic liver, whatever the etiology of cirrhosis, will be included. criteria for the diagnosis of hepatocellular carcinoma will be those defined by the european association for study of the liver (easl) (bruix j, j hepatol 2001):
boolean
C2239176 (UMLS CUI [1,1])
C0332253 (UMLS CUI [1,2])
C0023890 (UMLS CUI [1,3])
Lesion of liver Focal Diameter
Item
focal hepatic lesions ≥ 2cm in diameter:
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Alpha-fetoprotein measurement | Nodule Identification | Examination morphological Quantity | Abdominal Ultrasound | Abdominal angiography | CT of abdomen | MRI of abdomen | Arterial Hypervascularization
Item
alpha-fetoprotein (afp) < 400 ng/ml: nodules have to be identified by at least two coincident morphologic examinations (abdominal us, angiography, ct or mri) with arterial hypervascularisation in at least one of the imaging modalities
boolean
C0201539 (UMLS CUI [1])
C0028259 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
C0582103 (UMLS CUI [3,1])
C0543482 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C2348813 (UMLS CUI [4])
C0412251 (UMLS CUI [5])
C0412620 (UMLS CUI [6])
C0412693 (UMLS CUI [7])
C3831472 (UMLS CUI [8])
Alpha-fetoprotein measurement | Lesion seen Imaging
Item
afp > 400 ng/ml: lesion seen in a single imaging modality
boolean
C0201539 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C0205397 (UMLS CUI [2,2])
C0079595 (UMLS CUI [2,3])
Lesion of liver Focal Diameter
Item
focal hepatic lesions < 2 cm in diameter:
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Lesion Diameter Fine needle aspiration biopsy
Item
lesions 1 to 2 cm in diameter:use of fine-needle aspiration with biopsy
boolean
C0221198 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C1510483 (UMLS CUI [1,3])
Lesion Diameter Abdominal Ultrasound Series
Item
lesions < 1 cm: serial abdominal us every 3 months until the lesion exceeds 1 cm in size so that biopsy becomes possible. such cases will be included after diagnosis confirmation.
boolean
C0221198 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C2348813 (UMLS CUI [1,3])
C0205549 (UMLS CUI [1,4])
Lesion Focal Size | Liver Cirrhosis
Item
whatever the size of focal lesions, the diagnosis of cirrhosis will be made according to the same criteria as in the cirrhotic group control.
boolean
C0221198 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0023890 (UMLS CUI [2])
Patients Cirrhotic Control Group
Item
* cirrhotic control patients:
boolean
C0030705 (UMLS CUI [1,1])
C0439686 (UMLS CUI [1,2])
C0009932 (UMLS CUI [1,3])
Liver Cirrhosis
Item
all patients with cirrhosis, whatever its etiology, will be included. the diagnosis of cirrhosis will rely on:
boolean
C0023890 (UMLS CUI [1])
Biopsy of liver
Item
histological confirmation by liver biopsy or in the absence of biopsy:
boolean
C0193388 (UMLS CUI [1])
Portal vein thrombosis Free of Doppler Ultrasound Imaging | Portal Hypertension Biological measurement | Pancytopenia | Portal Hypertension Measurement morphological | Abdominal Ultrasound | CT of abdomen | MRI of abdomen | Portal Hypertension Hepatic venous pressure gradient | Endoscopy of stomach | Portal hypertensive gastropathy | Gastric Varices
Item
in patients free of portal thrombosis at doppler imaging, on the presence of portal hypertension ascertained by biological (tricytopenia), morphologic (abdominal us, ct or mri), hepatic venous pressure measurement or upper endoscopy (mosaic gastropathy, varices).
boolean
C0155773 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C2713308 (UMLS CUI [1,3])
C0020541 (UMLS CUI [2,1])
C0814047 (UMLS CUI [2,2])
C0030312 (UMLS CUI [3])
C0020541 (UMLS CUI [4,1])
C0242485 (UMLS CUI [4,2])
C0543482 (UMLS CUI [4,3])
C2348813 (UMLS CUI [5])
C0412620 (UMLS CUI [6])
C0412693 (UMLS CUI [7])
C0020541 (UMLS CUI [8,1])
C4049263 (UMLS CUI [8,2])
C0017195 (UMLS CUI [9])
C0580174 (UMLS CUI [10])
C0017145 (UMLS CUI [11])
Portal vein thrombosis | Portal Hypertension Associated with Sign or Symptom Liver Cirrhosis | Hepatomegaly Associated with Liver Failure | Spider nevus | Palmar erythema | Other Coding | Gynecomastia | Portal Hypertension Associated with Signs morphological Liver Cirrhosis | Hepatomegaly | Surface Nodular | Other Coding
Item
in patients with portal thrombosis, on the presence of portal hypertension associated with: clinical (hepatomegaly with clinical evidence of hepatocellular failure: spider naevi, palmar erythema, white mails, gynecomastia) or morphological signs of cirrhosis (enlarged liver, nodular surface, sharp lower edge).
boolean
C0155773 (UMLS CUI [1])
C0020541 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C3540840 (UMLS CUI [2,3])
C0023890 (UMLS CUI [2,4])
C0019209 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0085605 (UMLS CUI [3,3])
C0085666 (UMLS CUI [4])
C0014745 (UMLS CUI [5])
C3846158 (UMLS CUI [6])
C0018418 (UMLS CUI [7])
C0020541 (UMLS CUI [8,1])
C0332281 (UMLS CUI [8,2])
C0220912 (UMLS CUI [8,3])
C0543482 (UMLS CUI [8,4])
C0023890 (UMLS CUI [8,5])
C0019209 (UMLS CUI [9])
C0205148 (UMLS CUI [10,1])
C0205297 (UMLS CUI [10,2])
C3846158 (UMLS CUI [11])
Signs biological Liver Failure | Total protein measurement | Blood albumin decreased | Sinusoid Obstruction | Hepatic venous pressure gradient | FibroTest Score Measurement | Other Coding
Item
and/or biological signs of hepatocellular failure (tp<70%, low albuminemia) and/or sinusoidal block assessed by liver venous gradient > 18mmhg in the present state of knowledge, a fibrotest value at 4 or a fibroscan value > 12.5 kilopascal.
boolean
C0220912 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
C0085605 (UMLS CUI [1,3])
C0555903 (UMLS CUI [2])
C0853777 (UMLS CUI [3])
C0682624 (UMLS CUI [4,1])
C0028778 (UMLS CUI [4,2])
C4049263 (UMLS CUI [5])
C3642160 (UMLS CUI [6])
C3846158 (UMLS CUI [7])
Liver Cirrhosis | Hepatitis C, Chronic
Item
without any other clinical or biological signs will be considered as diagnosis criteria of cirrhosis only for chronic viral c hepatitis.
boolean
C0023890 (UMLS CUI [1])
C0524910 (UMLS CUI [2])
Patients Cirrhotic | Liver carcinoma Lacking | Imaging | Abdominal Ultrasound | CT of abdomen | MRI of abdomen | Alpha-fetoprotein measurement
Item
the lack of hepatocellular carcinoma in cirrhotic patients at inclusion will be assessed through good quality imaging examinations (abdominal us, ct scan or mri) and afp below 100 ng/ml.
boolean
C0030705 (UMLS CUI [1,1])
C0439686 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0079595 (UMLS CUI [3])
C2348813 (UMLS CUI [4])
C0412620 (UMLS CUI [5])
C0412693 (UMLS CUI [6])
C0201539 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Age
Item
age under 35 of year
boolean
C0001779 (UMLS CUI [1])
Cancer Other Evolving
Item
other cancer in evolution
boolean
C1707251 (UMLS CUI [1,1])
C0332253 (UMLS CUI [1,2])
HIV Infection
Item
hiv infection
boolean
C0019693 (UMLS CUI [1])
Mental disorders Prevalence Somatic Major
Item
major somatic pr psychiatric illness not compatible with the inclusion in the study
boolean
C0004936 (UMLS CUI [1,1])
C0220900 (UMLS CUI [1,2])
C2986476 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
Cancer Other | Exception Liver carcinoma
Item
no hepatocellular carcinoma primary liver cancer.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
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