ID

31529

Description

Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00966251

Link

https://clinicaltrials.gov/show/NCT00966251

Keywords

  1. 9/1/18 9/1/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 1, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Primary Hepatocellular Carcinoma NCT00966251

Eligibility Primary Hepatocellular Carcinoma NCT00966251

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects aged 18 years and above, both genders.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. histologically or cytologically confirmed primary hepatocellular carcinoma (hcc)
Description

Adult Primary Hepatocellular Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0279607
3. no fibrolamellar subtype hcc
Description

Fibrolamellar Hepatocellular Carcinoma Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0334287
UMLS CUI [1,2]
C0332197
4. not eligible for any other systemic anti-neoplastic treatment approved for hcc
Description

Patients Inappropriate Cancer treatment Other | Cancer treatment Systemic Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0920425
UMLS CUI [1,4]
C0205394
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C2239176
5. not eligible for transarterial chemoembolization (tace ).
Description

Patients Inappropriate Transarterial Chemoembolization

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C3539919
6. no more than 1 prior systemic therapy. previous tace or radiofrequency ablation (rfa) that were used for hcc, are permitted.
Description

Systemic therapy Quantity | Transarterial Chemoembolization Previous Liver carcinoma | Radiofrequency ablation Previous Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C3539919
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C2239176
UMLS CUI [3,1]
C0850292
UMLS CUI [3,2]
C0205156
UMLS CUI [3,3]
C2239176
7. not a candidate for curative surgical resection or liver transplantation
Description

Patients Inappropriate Excision Curative | Patients Inappropriate Transplantation of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0728940
UMLS CUI [1,4]
C1276305
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0023911
8. measurable disease defined by the identification at least 1 measurable lesion by mri using recist criteria. tumor in area of tace or rfa must be enlarging post-procedure to be considered measurable disease.
Description

Measurable lesion Quantity MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0024485
9. alpha-fetoprotein (afp) greater than the upper limit of normal (uln)
Description

Elevated alpha-fetoprotein

Data type

boolean

Alias
UMLS CUI [1]
C0235971
10. child's pugh classification a
Description

Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C2347612
11. ecog performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients progressing to liver failure.
Description

Disease Progression Towards Liver Failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C3875150
UMLS CUI [1,3]
C0085605
2. no core biopsy within the past 7 days
Description

Core needle biopsy

Data type

boolean

Alias
UMLS CUI [1]
C1318309
3. patients who are eligible for transarterial chemoembolization (tace)
Description

Patients Eligible Transarterial Chemoembolization

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C3539919
4. patients on concurrent anti-neoplastic therapy (including interferon)
Description

Cancer treatment | Interferon

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C3652465
5. patients who have received any systemic anti-neoplastic therapy not approved for the treatment of hcc.
Description

Cancer treatment Systemic Unapproved Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C1443286
UMLS CUI [1,4]
C2239176
6. patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
Description

Steroids | Exception Antiemetics | Inhaled steroids

Data type

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003297
UMLS CUI [3]
C2065041
7. presence of metastasis.
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627

Similar models

Eligibility Primary Hepatocellular Carcinoma NCT00966251

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subjects aged 18 years and above, both genders.
boolean
C0001779 (UMLS CUI [1])
Adult Primary Hepatocellular Carcinoma
Item
2. histologically or cytologically confirmed primary hepatocellular carcinoma (hcc)
boolean
C0279607 (UMLS CUI [1])
Fibrolamellar Hepatocellular Carcinoma Absent
Item
3. no fibrolamellar subtype hcc
boolean
C0334287 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Patients Inappropriate Cancer treatment Other | Cancer treatment Systemic Liver carcinoma
Item
4. not eligible for any other systemic anti-neoplastic treatment approved for hcc
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0920425 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
Patients Inappropriate Transarterial Chemoembolization
Item
5. not eligible for transarterial chemoembolization (tace ).
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C3539919 (UMLS CUI [1,3])
Systemic therapy Quantity | Transarterial Chemoembolization Previous Liver carcinoma | Radiofrequency ablation Previous Liver carcinoma
Item
6. no more than 1 prior systemic therapy. previous tace or radiofrequency ablation (rfa) that were used for hcc, are permitted.
boolean
C1515119 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3539919 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
C0850292 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C2239176 (UMLS CUI [3,3])
Patients Inappropriate Excision Curative | Patients Inappropriate Transplantation of liver
Item
7. not a candidate for curative surgical resection or liver transplantation
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C1276305 (UMLS CUI [1,4])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0023911 (UMLS CUI [2,3])
Measurable lesion Quantity MRI
Item
8. measurable disease defined by the identification at least 1 measurable lesion by mri using recist criteria. tumor in area of tace or rfa must be enlarging post-procedure to be considered measurable disease.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
Elevated alpha-fetoprotein
Item
9. alpha-fetoprotein (afp) greater than the upper limit of normal (uln)
boolean
C0235971 (UMLS CUI [1])
Child-Pugh Classification
Item
10. child's pugh classification a
boolean
C2347612 (UMLS CUI [1])
ECOG performance status
Item
11. ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Progression Towards Liver Failure
Item
1. patients progressing to liver failure.
boolean
C0242656 (UMLS CUI [1,1])
C3875150 (UMLS CUI [1,2])
C0085605 (UMLS CUI [1,3])
Core needle biopsy
Item
2. no core biopsy within the past 7 days
boolean
C1318309 (UMLS CUI [1])
Patients Eligible Transarterial Chemoembolization
Item
3. patients who are eligible for transarterial chemoembolization (tace)
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C3539919 (UMLS CUI [1,3])
Cancer treatment | Interferon
Item
4. patients on concurrent anti-neoplastic therapy (including interferon)
boolean
C0920425 (UMLS CUI [1])
C3652465 (UMLS CUI [2])
Cancer treatment Systemic Unapproved Liver carcinoma
Item
5. patients who have received any systemic anti-neoplastic therapy not approved for the treatment of hcc.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1443286 (UMLS CUI [1,3])
C2239176 (UMLS CUI [1,4])
Steroids | Exception Antiemetics | Inhaled steroids
Item
6. patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
boolean
C0038317 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003297 (UMLS CUI [2,2])
C2065041 (UMLS CUI [3])
Neoplasm Metastasis
Item
7. presence of metastasis.
boolean
C0027627 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial