ID

44516

Beschreibung

The Effect of Postoperative Interferon- Alpha Treatment in Low miR-26 Expression Patients With HCC; ODM derived from: https://clinicaltrials.gov/show/NCT01681446

Link

https://clinicaltrials.gov/show/NCT01681446

Stichworte

Versionen (2)
  1. 20.02.20 20.02.20 -
  2. 27.09.21 27.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01681446

Englisch

Eligibility Hepatocellular Carcinoma NCT01681446

1 Formulare  
Criteria
Beschreibung

Criteria

1. signed informed consent;
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. aged ≥ 18 years and ≤ 75 years old, male or female；
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. patients with low mir-26 expression(confirmed by rt-pcr) underwent a curative resection of hcc;
Beschreibung

Other Coding | Excision Curative Liver carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0728940
UMLS CUI [2,2]
C1276305
UMLS CUI [2,3]
C2239176
4. the tumor characteristics must meet the following:
Beschreibung

Tumor Characteristics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1521970
1. tumor diameter is between 3 to 8 centimeters,and the number of tumor is less tnan 3
Beschreibung

Tumor Diameter | Tumor Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1301886
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1265611
2. no thrombosis is detected in the main branches of the portal vein, hepatic vein and bile duct
Beschreibung

Portal vein thrombosis Absent | Hepatic Vein Thrombosis Absent | Bile duct Thrombosis Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0155773
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0019154
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0005400
UMLS CUI [3,2]
C0040053
UMLS CUI [3,3]
C0332197
3. no extrahepatic and lymphnode metastasis
Beschreibung

Neoplasm Metastasis Extrahepatic Absent | Secondary malignant neoplasm of lymph node Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0686619
UMLS CUI [2,2]
C0332197
perioperative period exclusion criteria:
Beschreibung

Perioperative Period Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712230
UMLS CUI [1,2]
C0680251
1. concomitant malignant primary tumor(s) in other systems is/are present;
Beschreibung

Primary tumor System Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0460002
UMLS CUI [1,3]
C0205394
2. the subject receives any previous systemic anti-hcc therapy prior to the resection surgery (except the resection surgery), such as liver transplantation, intervention, ablation, radiotherapy, chemotherapy, molecular targeted therapy or other anti-hcc therapy;
Beschreibung

Systemic therapy Liver carcinoma | Status pre- Excision | Transplantation of liver | Intervention | Ablation | Therapeutic radiology procedure | Chemotherapy | Molecular Targeted Therapy | Therapy Liver carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C2239176
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0728940
UMLS CUI [3]
C0023911
UMLS CUI [4]
C0184661
UMLS CUI [5]
C0547070
UMLS CUI [6]
C1522449
UMLS CUI [7]
C0392920
UMLS CUI [8]
C2699893
UMLS CUI [9,1]
C0087111
UMLS CUI [9,2]
C2239176
3. the subject takes other study/investigational drugs during this study;
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
4. the subject has cerebrovascular accident, renal insufficiency, depression, hyperthyreosis, hypothyroidism or other severe uncontrolled diseases;
Beschreibung

Cerebrovascular accident | Renal Insufficiency | Depressive disorder | Hyperthyroidism | Hypothyroidism | Disease Severe Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0011581
UMLS CUI [4]
C0020550
UMLS CUI [5]
C0020676
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C0205318
5. the subject has a history of study drug or similar drug allergy.
Beschreibung

Hypersensitivity Investigational New Drugs | Drug Allergy Similar

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0013182
UMLS CUI [2,2]
C2348205
baseline (post-surgeryday 25 ± 5) inclusion criteria:
Beschreibung

Postoperative Period Inclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032790
UMLS CUI [1,2]
C1512693
1. baseline (post-resection) blood routine examination shows that the number of leukocyte>2.5*10^9/l and platelet count>40*10^9/l;
Beschreibung

Status post Excision | Blood Examination | White Blood Cell Count procedure | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0728940
UMLS CUI [2]
C3826648
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0032181
2. child-pugh score of class a at baseline.
Beschreibung

Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C4050412
baseline (post-surgeryday 25 ± 5) exclusion criteria:
Beschreibung

Postoperative Period Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032790
UMLS CUI [1,2]
C0680251
1. concomitant malignant primary tumor(s) in other systems is/are present;
Beschreibung

Primary tumor System Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0460002
UMLS CUI [1,3]
C0205394
2. the subject takes other study/investigational drugs within 4 weeks prior to randomization;
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
3. the baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present;
Beschreibung

Communicable Disease | Hemorrhage | Leakage of bile | Postoperative Complications

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019080
UMLS CUI [3]
C0400997
UMLS CUI [4]
C0032787
4. the baseline examination suggests the presence of tumor metastasis;
Beschreibung

Suggestive of Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332299
UMLS CUI [1,2]
C0027627
5. the subject has cerebrovascular accident, renal insufficiency, depression, hyperthyreosis, hypothyroidism or other severe uncontrolled diseases;
Beschreibung

Cerebrovascular accident | Renal Insufficiency | Depressive disorder | Hyperthyroidism | Hypothyroidism | Disease Severe Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0011581
UMLS CUI [4]
C0020550
UMLS CUI [5]
C0020676
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C0205318
6. the subject has a history of investigational drug or similar drug allergy;
Beschreibung

Hypersensitivity Investigational New Drugs | Drug Allergy Similar

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0013182
UMLS CUI [2,2]
C2348205
7. the subject is pregnant, lactating, or urine pregnancy test result is positive.
Beschreibung

Pregnancy | Breast Feeding | Urine pregnancy test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0430059
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Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT01681446

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Informed Consent
Item
1. signed informed consent;
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. aged ≥ 18 years and ≤ 75 years old, male or female；
boolean
C0001779 (UMLS CUI [1])
Other Coding | Excision Curative Liver carcinoma
Item
3. patients with low mir-26 expression(confirmed by rt-pcr) underwent a curative resection of hcc;
boolean
C3846158 (UMLS CUI [1])
C0728940 (UMLS CUI [2,1])
C1276305 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
Tumor Characteristics
Item
4. the tumor characteristics must meet the following:
boolean
C0027651 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
Tumor Diameter | Tumor Quantity
Item
1. tumor diameter is between 3 to 8 centimeters,and the number of tumor is less tnan 3
boolean
C0027651 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Portal vein thrombosis Absent | Hepatic Vein Thrombosis Absent | Bile duct Thrombosis Absent
Item
2. no thrombosis is detected in the main branches of the portal vein, hepatic vein and bile duct
boolean
C0155773 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019154 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0005400 (UMLS CUI [3,1])
C0040053 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Neoplasm Metastasis Extrahepatic Absent | Secondary malignant neoplasm of lymph node Absent
Item
3. no extrahepatic and lymphnode metastasis
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0686619 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Perioperative Period Exclusion Criteria
Item
perioperative period exclusion criteria:
boolean
C2712230 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Primary tumor System Other
Item
1. concomitant malignant primary tumor(s) in other systems is/are present;
boolean
C0677930 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Systemic therapy Liver carcinoma | Status pre- Excision | Transplantation of liver | Intervention | Ablation | Therapeutic radiology procedure | Chemotherapy | Molecular Targeted Therapy | Therapy Liver carcinoma
Item
2. the subject receives any previous systemic anti-hcc therapy prior to the resection surgery (except the resection surgery), such as liver transplantation, intervention, ablation, radiotherapy, chemotherapy, molecular targeted therapy or other anti-hcc therapy;
boolean
C1515119 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C0728940 (UMLS CUI [2,2])
C0023911 (UMLS CUI [3])
C0184661 (UMLS CUI [4])
C0547070 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
C0392920 (UMLS CUI [7])
C2699893 (UMLS CUI [8])
C0087111 (UMLS CUI [9,1])
C2239176 (UMLS CUI [9,2])
Investigational New Drugs
Item
3. the subject takes other study/investigational drugs during this study;
boolean
C0013230 (UMLS CUI [1])
Cerebrovascular accident | Renal Insufficiency | Depressive disorder | Hyperthyroidism | Hypothyroidism | Disease Severe Uncontrolled
Item
4. the subject has cerebrovascular accident, renal insufficiency, depression, hyperthyreosis, hypothyroidism or other severe uncontrolled diseases;
boolean
C0038454 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0011581 (UMLS CUI [3])
C0020550 (UMLS CUI [4])
C0020676 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0205318 (UMLS CUI [6,3])
Hypersensitivity Investigational New Drugs | Drug Allergy Similar
Item
5. the subject has a history of study drug or similar drug allergy.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2,1])
C2348205 (UMLS CUI [2,2])
Postoperative Period Inclusion criteria
Item
baseline (post-surgeryday 25 ± 5) inclusion criteria:
boolean
C0032790 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Status post Excision | Blood Examination | White Blood Cell Count procedure | Platelet Count measurement
Item
1. baseline (post-resection) blood routine examination shows that the number of leukocyte>2.5*10^9/l and platelet count>40*10^9/l;
boolean
C0231290 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C3826648 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Child-Pugh Classification
Item
2. child-pugh score of class a at baseline.
boolean
C4050412 (UMLS CUI [1])
Postoperative Period Exclusion Criteria
Item
baseline (post-surgeryday 25 ± 5) exclusion criteria:
boolean
C0032790 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Primary tumor System Other
Item
1. concomitant malignant primary tumor(s) in other systems is/are present;
boolean
C0677930 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Investigational New Drugs
Item
2. the subject takes other study/investigational drugs within 4 weeks prior to randomization;
boolean
C0013230 (UMLS CUI [1])
Communicable Disease | Hemorrhage | Leakage of bile | Postoperative Complications
Item
3. the baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present;
boolean
C0009450 (UMLS CUI [1])
C0019080 (UMLS CUI [2])
C0400997 (UMLS CUI [3])
C0032787 (UMLS CUI [4])
Suggestive of Neoplasm Metastasis
Item
4. the baseline examination suggests the presence of tumor metastasis;
boolean
C0332299 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Cerebrovascular accident | Renal Insufficiency | Depressive disorder | Hyperthyroidism | Hypothyroidism | Disease Severe Uncontrolled
Item
5. the subject has cerebrovascular accident, renal insufficiency, depression, hyperthyreosis, hypothyroidism or other severe uncontrolled diseases;
boolean
C0038454 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0011581 (UMLS CUI [3])
C0020550 (UMLS CUI [4])
C0020676 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0205318 (UMLS CUI [6,3])
Hypersensitivity Investigational New Drugs | Drug Allergy Similar
Item
6. the subject has a history of investigational drug or similar drug allergy;
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2,1])
C2348205 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Urine pregnancy test positive
Item
7. the subject is pregnant, lactating, or urine pregnancy test result is positive.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430059 (UMLS CUI [3])
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