ID

18933

Descripción

Study of CEP-701 in Treatment of Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00081601

Link

https://clinicaltrials.gov/show/NCT00081601

Palabras clave

Versiones (1)
  1. 25/11/16 25/11/16 -
Subido en

25 de noviembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00081601

Inglés

Eligibility Prostate Cancer NCT00081601

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least 18 yrs of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of adenocarcinoma of the prostate
Descripción

Adenocarcinoma of prostate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007112
no detectable metastatic disease as assessed by bone and ct scans
Descripción

Neoplasm Metastasis Detectable | Radioisotope scan of bone | X-Ray Computed Tomography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C3830527
UMLS CUI [2]
C0203668
UMLS CUI [3]
C0040405
has increasing serum psa concentrations
Descripción

Serum Prostate Specific Antigen Increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1883014
life expectancy of at least 3 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
ecog of 0 or 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period
Descripción

Antiandrogen therapy Withdrawn

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0424092
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
has asymptomatic disease
Descripción

Asymptomatic Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2936329
has active gi ulceration or bleeding
Descripción

Gastrointestinal ulcer | Gastrointestinal Hemorrhage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0237938
UMLS CUI [2]
C0017181
has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit
Descripción

cancer treatment Systemic Hormonal | Therapeutic radiology procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0458083
UMLS CUI [2]
C1522449
bilirubin >2x uln or alt or ast >2xuln or serum creatinine >1.5mg/dl
Descripción

Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201976
hemoglobin <9g/dl or platelets below 100,000/ul or anc below 1500/ul
Descripción

Hemoglobin | Platelet Count measurement | Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0948762
receiving treatment for hiv with protease inhibitors
Descripción

HIV Protease Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0162714
has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin
Descripción

Malignant Neoplasms | Basal cell carcinoma Resected | Squamous cell carcinoma of skin Resected

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1521996
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1521996
has used investigational drug with previous one month
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Prostate Cancer NCT00081601

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
at least 18 yrs of age
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Neoplasm Metastasis Detectable | Radioisotope scan of bone | X-Ray Computed Tomography
Item
no detectable metastatic disease as assessed by bone and ct scans
boolean
C0027627 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0203668 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
Serum Prostate Specific Antigen Increased
Item
has increasing serum psa concentrations
boolean
C1883014 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Antiandrogen therapy Withdrawn
Item
has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period
boolean
C0279492 (UMLS CUI [1,1])
C0424092 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Asymptomatic Disease
Item
has asymptomatic disease
boolean
C2936329 (UMLS CUI [1])
Gastrointestinal ulcer | Gastrointestinal Hemorrhage
Item
has active gi ulceration or bleeding
boolean
C0237938 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
cancer treatment Systemic Hormonal | Therapeutic radiology procedure
Item
has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0458083 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
bilirubin >2x uln or alt or ast >2xuln or serum creatinine >1.5mg/dl
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
Hemoglobin | Platelet Count measurement | Absolute neutrophil count
Item
hemoglobin <9g/dl or platelets below 100,000/ul or anc below 1500/ul
boolean
C0019046 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
HIV Protease Inhibitors
Item
receiving treatment for hiv with protease inhibitors
boolean
C0162714 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma Resected | Squamous cell carcinoma of skin Resected
Item
has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1521996 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1521996 (UMLS CUI [3,2])
Investigational New Drugs
Item
has used investigational drug with previous one month
boolean
C0013230 (UMLS CUI [1])
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