ID

40921

Beschreibung

A Study of IMC-A12 in Combination With Sorafenib in Patients With Advanced Cancer of the Liver; ODM derived from: https://clinicaltrials.gov/show/NCT00906373

Link

https://clinicaltrials.gov/show/NCT00906373

Stichworte

  1. 05.06.20 05.06.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. Juni 2020

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Hepatocellular Carcinoma NCT00906373

Eligibility Hepatocellular Carcinoma NCT00906373

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient has histologically or cytologically confirmed, unresectable hcc
Beschreibung

Liver cell carcinoma non-resectable

Datentyp

boolean

Alias
UMLS CUI [1]
C1112459
the patient has at least one target lesion measurable according to response evaluation criteria in solid tumors (recist) guidelines. target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area. if a lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity, in order for such a lesion to be considered a target lesion
Beschreibung

Target Lesion Measurable Quantity | Target Lesion Therapeutic radiology procedure Absent | Target Lesion Ablation Absent | Target Lesion Chemoembolization Absent | Tumor growth | Tumor hypervascular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C2986546
UMLS CUI [3,2]
C0547070
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C2986546
UMLS CUI [4,2]
C0796679
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C0598934
UMLS CUI [6,1]
C0027651
UMLS CUI [6,2]
C1512560
the patient has not received prior systemic therapy for hcc. patients may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery
Beschreibung

Systemic therapy Absent Liver carcinoma | Embolization | Chemoembolization | Chemotherapy by intra-arterial infusion | Ethanol Injection | Radiofrequency ablation | Cryosurgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C2239176
UMLS CUI [2]
C0013931
UMLS CUI [3]
C0796679
UMLS CUI [4]
C2045832
UMLS CUI [5]
C4307245
UMLS CUI [6]
C0850292
UMLS CUI [7]
C0010408
the patient has fasting serum glucose < 160 mg/dl or below the uln and/or hemoglobin a1c < 7%. if baseline nonfasting glucose < 160 mg/dl, fasting glucose measurement is not required
Beschreibung

Serum fasting glucose measurement | Hemoglobin A1c measurement | Glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0583334
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0337438
the patient has the ability to understand and the willingness to sign a written informed consent document
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient has brain metastases
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
the patient has acute hepatitis
Beschreibung

Hepatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0019158
the patient has poorly controlled diabetes mellitus. patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range and that they are on a stable dietary or therapeutic regimen for this condition
Beschreibung

Poorly controlled diabetes mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0554876
the patient has congestive heart failure > class ii nyha, unstable angina pectoris, new onset of angina pectoris, myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy
Beschreibung

Congestive heart failure New York Heart Association Classification | Angina, Unstable | New onset angina | Myocardial Infarction | Ventricular arrhythmia Requirement Anti-Arrhythmia Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0340289
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0085612
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0003195
the patient has experienced a hemorrhage or bleeding event ≥ nci-ctcae grade 3 within 4 weeks prior first dose of study therapy
Beschreibung

Hemorrhage CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1516728

Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT00906373

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver cell carcinoma non-resectable
Item
the patient has histologically or cytologically confirmed, unresectable hcc
boolean
C1112459 (UMLS CUI [1])
Target Lesion Measurable Quantity | Target Lesion Therapeutic radiology procedure Absent | Target Lesion Ablation Absent | Target Lesion Chemoembolization Absent | Tumor growth | Tumor hypervascular
Item
the patient has at least one target lesion measurable according to response evaluation criteria in solid tumors (recist) guidelines. target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area. if a lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity, in order for such a lesion to be considered a target lesion
boolean
C2986546 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C2986546 (UMLS CUI [3,1])
C0547070 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C2986546 (UMLS CUI [4,1])
C0796679 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0598934 (UMLS CUI [5])
C0027651 (UMLS CUI [6,1])
C1512560 (UMLS CUI [6,2])
Systemic therapy Absent Liver carcinoma | Embolization | Chemoembolization | Chemotherapy by intra-arterial infusion | Ethanol Injection | Radiofrequency ablation | Cryosurgery
Item
the patient has not received prior systemic therapy for hcc. patients may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery
boolean
C1515119 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C0013931 (UMLS CUI [2])
C0796679 (UMLS CUI [3])
C2045832 (UMLS CUI [4])
C4307245 (UMLS CUI [5])
C0850292 (UMLS CUI [6])
C0010408 (UMLS CUI [7])
Serum fasting glucose measurement | Hemoglobin A1c measurement | Glucose measurement
Item
the patient has fasting serum glucose < 160 mg/dl or below the uln and/or hemoglobin a1c < 7%. if baseline nonfasting glucose < 160 mg/dl, fasting glucose measurement is not required
boolean
C0583334 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0337438 (UMLS CUI [3])
Informed Consent
Item
the patient has the ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain
Item
the patient has brain metastases
boolean
C0220650 (UMLS CUI [1])
Hepatitis
Item
the patient has acute hepatitis
boolean
C0019158 (UMLS CUI [1])
Poorly controlled diabetes mellitus
Item
the patient has poorly controlled diabetes mellitus. patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range and that they are on a stable dietary or therapeutic regimen for this condition
boolean
C0554876 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification | Angina, Unstable | New onset angina | Myocardial Infarction | Ventricular arrhythmia Requirement Anti-Arrhythmia Agents
Item
the patient has congestive heart failure > class ii nyha, unstable angina pectoris, new onset of angina pectoris, myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0340289 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085612 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0003195 (UMLS CUI [5,3])
Hemorrhage CTCAE Grades
Item
the patient has experienced a hemorrhage or bleeding event ≥ nci-ctcae grade 3 within 4 weeks prior first dose of study therapy
boolean
C0019080 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])

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