ID

20937

Description

Transplant-Related Accelerated Progression of Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00368225

Link

https://clinicaltrials.gov/show/NCT00368225

Keywords

Versions (1)
  1. 3/29/17 3/29/17 -
Uploaded on

March 29, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00368225

English

Eligibility Hepatitis C NCT00368225

1 forms  
Criteria
Description

Criteria

to fulfill criteria for study entry, the patient must:
Description

criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
be 18 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have detectable hcv rna
Description

HCV viral load Detectable

Data type

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C3830527
require orthotopic liver transplantation for chronic hepatitis c induced cirrhosis or require renal transplantation for end-stage kidney disease
Description

Orthotopic liver transplant Patient need for | Liver Cirrhosis Due to Chronic Hepatitis C | Kidney Transplantation Patient need for | Kidney Failure, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0400447
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0524910
UMLS CUI [3,1]
C0022671
UMLS CUI [3,2]
C0686904
UMLS CUI [4]
C0022661
have a meld score greater than 18 (for liver transplant patients) or have an otherwise high probability of receiving a liver or kidney transplant within six months of enrollment based on assessment by the clinical transplant team at each hospital.
Description

Transplantation of liver Model for end stage liver disease score | Transplantation of liver Probability High | Kidney Transplantation Probability High

Data type

boolean

Alias
UMLS CUI [1,1]
C0023911
UMLS CUI [1,2]
C4048785
UMLS CUI [2,1]
C0023911
UMLS CUI [2,2]
C0033204
UMLS CUI [2,3]
C0205250
UMLS CUI [3,1]
C0022671
UMLS CUI [3,2]
C0033204
UMLS CUI [3,3]
C0205250
be able/willing to travel to the collaborating center for blood sampling prior to liver or kidney transplantation, and at 2, 3, 4, 5, 6, 8, 12, 16, 24 weeks after transplantation and then bi-annually until the end of the study at 5 years
Description

Collection of blood specimen for laboratory procedure Willing | Transplantation of liver Prior to | Kidney Transplantation Prior to

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0023911
UMLS CUI [2,2]
C0332152
UMLS CUI [3,1]
C0022671
UMLS CUI [3,2]
C0332152
be willing to have study-related liver biopsies at 3 months, and then 1, 3 and 5 years after transplantation
Description

Biopsy of liver Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0600109
provide informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
to fulfill criteria for study entry, the patient must not:
Description

criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
be hiv or hepatitis b virus (hbsag) positive
Description

HIV Seropositivity | Hepatitis B Virus Positive | Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0019169
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0149709
receive a liver graft from an anti-hcv antibody positive or hbv core positive donor
Description

Recipient Liver graft | Tissue Donor Hepatitis C Antibodies Positive | Tissue Donor Hepatitis B Viral core Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C1720613
UMLS CUI [2,1]
C0040288
UMLS CUI [2,2]
C0166049
UMLS CUI [2,3]
C1514241
UMLS CUI [3,1]
C0040288
UMLS CUI [3,2]
C0019163
UMLS CUI [3,3]
C1268457
UMLS CUI [3,4]
C1514241
have other forms of liver disease including primary biliary cirrhosis, autoimmune hepatitis, hemochromatosis and wilson's disease
Description

Liver diseases | Primary biliary cirrhosis | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0008312
UMLS CUI [3]
C0241910
UMLS CUI [4]
C0018995
UMLS CUI [5]
C0019202
have hepatocellular carcinoma if any single lesion is 5 cm. or more or if there are 3 or more lesions exceeding 3 cm.
Description

Liver carcinoma Single lesion Size | Lesion Quantity Size

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0577304
UMLS CUI [1,3]
C0456389
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0456389
be on immunomodulatory medications such as corticosteroids within four weeks of collection of blood for pre-transplant baseline laboratory testing
Description

Immunomodulators | Adrenal Cortex Hormones | Collection of blood specimen for laboratory procedure Before Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C1527392
UMLS CUI [2]
C0001617
UMLS CUI [3,1]
C0005834
UMLS CUI [3,2]
C0332152
UMLS CUI [3,3]
C0040732
have been diagnosed with any hereditary or acquired immunodeficiency state prior to liver or kidney transplantation
Description

Immunodeficiency Hereditary Transplantation of liver Prior to | Immunodeficiency Hereditary Kidney Transplantation Prior to | Acquired immunodeficiency Transplantation of liver Prior to | Acquired immunodeficiency Kidney Transplantation Prior to

Data type

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C0439660
UMLS CUI [1,3]
C0023911
UMLS CUI [1,4]
C0332152
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0439660
UMLS CUI [2,3]
C0022671
UMLS CUI [2,4]
C0332152
UMLS CUI [3,1]
C0596032
UMLS CUI [3,2]
C0023911
UMLS CUI [3,3]
C0332152
UMLS CUI [4,1]
C0596032
UMLS CUI [4,2]
C0022671
UMLS CUI [4,3]
C0332152
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Similar models

Eligibility Hepatitis C NCT00368225

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
criteria Fulfill
Item
to fulfill criteria for study entry, the patient must:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
be 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
HCV viral load Detectable
Item
have detectable hcv rna
boolean
C1868902 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
Orthotopic liver transplant Patient need for | Liver Cirrhosis Due to Chronic Hepatitis C | Kidney Transplantation Patient need for | Kidney Failure, Chronic
Item
require orthotopic liver transplantation for chronic hepatitis c induced cirrhosis or require renal transplantation for end-stage kidney disease
boolean
C0400447 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
C0022671 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C0022661 (UMLS CUI [4])
Transplantation of liver Model for end stage liver disease score | Transplantation of liver Probability High | Kidney Transplantation Probability High
Item
have a meld score greater than 18 (for liver transplant patients) or have an otherwise high probability of receiving a liver or kidney transplant within six months of enrollment based on assessment by the clinical transplant team at each hospital.
boolean
C0023911 (UMLS CUI [1,1])
C4048785 (UMLS CUI [1,2])
C0023911 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0205250 (UMLS CUI [2,3])
C0022671 (UMLS CUI [3,1])
C0033204 (UMLS CUI [3,2])
C0205250 (UMLS CUI [3,3])
Collection of blood specimen for laboratory procedure Willing | Transplantation of liver Prior to | Kidney Transplantation Prior to
Item
be able/willing to travel to the collaborating center for blood sampling prior to liver or kidney transplantation, and at 2, 3, 4, 5, 6, 8, 12, 16, 24 weeks after transplantation and then bi-annually until the end of the study at 5 years
boolean
C0005834 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0023911 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0022671 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
Biopsy of liver Willing
Item
be willing to have study-related liver biopsies at 3 months, and then 1, 3 and 5 years after transplantation
boolean
C0193388 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Informed Consent
Item
provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
criteria Fulfill
Item
to fulfill criteria for study entry, the patient must not:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
HIV Seropositivity | Hepatitis B Virus Positive | Hepatitis B surface antigen positive
Item
be hiv or hepatitis b virus (hbsag) positive
boolean
C0019699 (UMLS CUI [1])
C0019169 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0149709 (UMLS CUI [3])
Recipient Liver graft | Tissue Donor Hepatitis C Antibodies Positive | Tissue Donor Hepatitis B Viral core Positive
Item
receive a liver graft from an anti-hcv antibody positive or hbv core positive donor
boolean
C1709854 (UMLS CUI [1,1])
C1720613 (UMLS CUI [1,2])
C0040288 (UMLS CUI [2,1])
C0166049 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0040288 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
C1268457 (UMLS CUI [3,3])
C1514241 (UMLS CUI [3,4])
Liver diseases | Primary biliary cirrhosis | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration
Item
have other forms of liver disease including primary biliary cirrhosis, autoimmune hepatitis, hemochromatosis and wilson's disease
boolean
C0023895 (UMLS CUI [1])
C0008312 (UMLS CUI [2])
C0241910 (UMLS CUI [3])
C0018995 (UMLS CUI [4])
C0019202 (UMLS CUI [5])
Liver carcinoma Single lesion Size | Lesion Quantity Size
Item
have hepatocellular carcinoma if any single lesion is 5 cm. or more or if there are 3 or more lesions exceeding 3 cm.
boolean
C2239176 (UMLS CUI [1,1])
C0577304 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
Immunomodulators | Adrenal Cortex Hormones | Collection of blood specimen for laboratory procedure Before Transplantation
Item
be on immunomodulatory medications such as corticosteroids within four weeks of collection of blood for pre-transplant baseline laboratory testing
boolean
C1527392 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0005834 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
C0040732 (UMLS CUI [3,3])
Immunodeficiency Hereditary Transplantation of liver Prior to | Immunodeficiency Hereditary Kidney Transplantation Prior to | Acquired immunodeficiency Transplantation of liver Prior to | Acquired immunodeficiency Kidney Transplantation Prior to
Item
have been diagnosed with any hereditary or acquired immunodeficiency state prior to liver or kidney transplantation
boolean
C0021051 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0023911 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0022671 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C0596032 (UMLS CUI [3,1])
C0023911 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C0596032 (UMLS CUI [4,1])
C0022671 (UMLS CUI [4,2])
C0332152 (UMLS CUI [4,3])
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