ID

13665

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00149565

Trefwoorden

Versies (2)
  1. 24-02-16 24-02-16 -
  2. 20-09-21 20-09-21 -
Geüploaded op

24 februari 2016

DOI

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Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00149565

Engels

Eligibility Hepatocellular Carcinoma NCT00149565

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

hepatocellular carcinoma

Datatype

boolean

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

surgery

Datatype

boolean

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

resection margin

Datatype

boolean

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

Age

Datatype

boolean

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

ecog

Datatype

boolean

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

liver function and hemogram

Datatype

boolean

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

pugh-child score

Datatype

boolean

Alias
UMLS CUI [1]
C2347612
8. the serum total bilirubin level are < 2 mg/dl.
Beschrijving

bilirubin

Datatype

boolean

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

prothrombin time

Datatype

boolean

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

platelets

Datatype

boolean

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

wbc

Datatype

boolean

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

creatinine

Datatype

boolean

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

nyha

Datatype

boolean

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

hbv or hcv

Datatype

boolean

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

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
exclusion criteria:
Beschrijving

ID.16

Datatype

boolean

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

surgery

Datatype

boolean

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

resection margins

Datatype

boolean

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

portal vein thrombus

Datatype

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.
Beschrijving

steroids or immunosuppressant agents

Datatype

boolean

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

malignancies

Datatype

boolean

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

pregnant or breast-feeding

Datatype

boolean

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

cardiopulmonary disease

Datatype

boolean

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

psychiatric disorder

Datatype

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.
Beschrijving

chemotherapy, immuno-therapeutic drugs or steroids within 6 weeks

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
C2347612 (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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