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Information:
Fel:
ID
31529
Beskrivning
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00966251
Länk
https://clinicaltrials.gov/show/NCT00966251
Nyckelord
Versioner (2)
- 2018-09-01 2018-09-01 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
1 september 2018
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Primary Hepatocellular Carcinoma NCT00966251
Eligibility Primary Hepatocellular Carcinoma NCT00966251
- StudyEvent: Eligibility
Similar models
Eligibility Primary Hepatocellular Carcinoma NCT00966251
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])