ID

43691

Descrição

Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00149565

Link

https://clinicaltrials.gov/show/NCT00149565

Palavras-chave

Versões (2)
  1. 24/02/2016 24/02/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00149565

Inglês

Eligibility Hepatocellular Carcinoma NCT00149565

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. histologically proven hepatocellular carcinoma.
Descrição

hepatocellular carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2239176
2. hcc underwent curative resection within 6 weeks before registration.
Descrição

surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0543467
3. grossly, the resection margin should be > 1 cm.
Descrição

resection margin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0229985
4. patients must be younger than 70 year-old.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
5. patients must have a performance status of ecog score < 2.
Descrição

ecog

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
6. patients must have adequate liver reservation and adequate hemogram.
Descrição

liver function and hemogram

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0200631
7. pugh-child‘s score < 7.
Descrição

pugh-child score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4050412
8. the serum total bilirubin level are < 2 mg/dl.
Descrição

bilirubin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
9. the prothrombin times are < 3 sec above normal control.
Descrição

prothrombin time

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033707
10. the platelet are > 10 x 104 / mm3.
Descrição

platelets

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005821
11. the wbc are > 3,000 / mm3.
Descrição

wbc

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023508
12. patient must have serum creatinine < 1.5 mg/dl
Descrição

creatinine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
13. cardiac function with nyha classification < grade ii
Descrição

nyha

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1275491
14. known hbv or hcv status.
Descrição

hbv or hcv

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
15. signed informed consent.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
exclusion criteria:
Descrição

ID.16

Tipo de dados

boolean

1. patients who have non-curative resection are not eligible.
Descrição

surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0543467
2. resected hccs with histologically positive margins are not eligible.
Descrição

resection margins

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0229985
3. hccs with radiological evidence of portal vein thrombus are not eligible.
Descrição

portal vein thrombus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0087086
UMLS CUI [2,2]
C0032718
4. patients with other systemic diseases which required concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
Descrição

steroids or immunosuppressant agents

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0021081
5. patients with advanced second primary malignancy are not eligible.
Descrição

malignancies

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
6. patients with pregnacy or breast-feeding are not eligible.
Descrição

pregnant or breast-feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. patients with severe cardiopulmonary diseases are not eligible.
Descrição

cardiopulmonary disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
8. patients with clinically significant psychiatric disorder are not eligible.
Descrição

psychiatric disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004936
9. patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
Descrição

chemotherapy, immuno-therapeutic drugs or steroids within 6 weeks

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3665472
UMLS CUI [2]
C0876248
UMLS CUI [3]
C0007222
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Similar models

Eligibility Hepatocellular Carcinoma NCT00149565

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
hepatocellular carcinoma
Item
1. histologically proven hepatocellular carcinoma.
boolean
C2239176 (UMLS CUI [1])
surgery
Item
2. hcc underwent curative resection within 6 weeks before registration.
boolean
C0543467 (UMLS CUI [1])
resection margin
Item
3. grossly, the resection margin should be > 1 cm.
boolean
C0229985 (UMLS CUI [1])
Age
Item
4. patients must be younger than 70 year-old.
boolean
C0001779 (UMLS CUI [1])
ecog
Item
5. patients must have a performance status of ecog score < 2.
boolean
C1520224 (UMLS CUI [1])
liver function and hemogram
Item
6. patients must have adequate liver reservation and adequate hemogram.
boolean
C0232741 (UMLS CUI [1])
C0200631 (UMLS CUI [2])
pugh-child score
Item
7. pugh-child‘s score < 7.
boolean
C4050412 (UMLS CUI [1])
bilirubin
Item
8. the serum total bilirubin level are < 2 mg/dl.
boolean
C1278039 (UMLS CUI [1])
prothrombin time
Item
9. the prothrombin times are < 3 sec above normal control.
boolean
C0033707 (UMLS CUI [1])
platelets
Item
10. the platelet are > 10 x 104 / mm3.
boolean
C0005821 (UMLS CUI [1])
wbc
Item
11. the wbc are > 3,000 / mm3.
boolean
C0023508 (UMLS CUI [1])
creatinine
Item
12. patient must have serum creatinine < 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
nyha
Item
13. cardiac function with nyha classification < grade ii
boolean
C1275491 (UMLS CUI [1])
hbv or hcv
Item
14. known hbv or hcv status.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
informed consent
Item
15. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
ID.16
Item
exclusion criteria:
boolean
surgery
Item
1. patients who have non-curative resection are not eligible.
boolean
C0543467 (UMLS CUI [1])
resection margins
Item
2. resected hccs with histologically positive margins are not eligible.
boolean
C0229985 (UMLS CUI [1])
portal vein thrombus
Item
3. hccs with radiological evidence of portal vein thrombus are not eligible.
boolean
C2239176 (UMLS CUI [1])
C0087086 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
steroids or immunosuppressant agents
Item
4. patients with other systemic diseases which required concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
boolean
C0038317 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
malignancies
Item
5. patients with advanced second primary malignancy are not eligible.
boolean
C0006826 (UMLS CUI [1])
pregnant or breast-feeding
Item
6. patients with pregnacy or breast-feeding are not eligible.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
cardiopulmonary disease
Item
7. patients with severe cardiopulmonary diseases are not eligible.
boolean
C0009488 (UMLS CUI [1])
psychiatric disorder
Item
8. patients with clinically significant psychiatric disorder are not eligible.
boolean
C0004936 (UMLS CUI [1])
chemotherapy, immuno-therapeutic drugs or steroids within 6 weeks
Item
9. patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
boolean
C3665472 (UMLS CUI [1])
C0876248 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
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