ID

14652

Descripción

Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT00223171

Link

https://clinicaltrials.gov/show/NCT00223171

Palabras clave

  1. 25/4/16 25/4/16 -
Subido en

25 de abril de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00223171

Eligibility Prostate Cancer NCT00223171

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
to have at least one of the following three risk factors:
Descripción

Risk factor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035648
tumour classified t3 or t4
Descripción

Prostate Cancer stage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0280280
gleason score 8-10
Descripción

Gleason score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0332326
prostate-specific antigen (psa) level > 20
Descripción

PSA measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201544
performance status score of 0-1.
Descripción

Performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518965
patients must sign a consent form before the start of the study.
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
no evidence of regional disease: clinically negative regional adenopathies are revealed by imaging (computed axial tomography [cat] scan, magnetic resonance imaging [mri], lymphography) or surgical staging or negative pelvic node dissection.
Descripción

Regional disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514819
no distant metastasis. these patients must all have a negative bone scan 12 weeks prior to randomization.
Descripción

Distant metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1269798
hormonal therapy is allowed up to a maximum of two months before the consent form is signed, as long as the initial work-up was done, including having the requested deadlines respected.
Descripción

Hormonal therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279025
patients with a previous history of cancer are eligible on the condition that they have not had any disease progression for more than five years.
Descripción

Malignancy: disease free survival

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0242793
the patient must be available for treatments and follow-up visits.
Descripción

Treatment and follow up

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C1522577
treatments must start in the three weeks following randomization.
Descripción

Treatment start date

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3173309
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe medical or psychiatric problems that could compromise study compliance.
Descripción

Comorbidity limiting compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
chronic hepatic disease, abnormal hepatic functions, i.e. aspartate aminotransferase, alanine aminotransferase > 1.5 times the upper normal limit.
Descripción

ALT and AST

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836

Similar models

Eligibility Prostate Cancer NCT00223171

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Risk factor
Item
to have at least one of the following three risk factors:
boolean
C0035648 (UMLS CUI [1])
Prostate Cancer stage
Item
tumour classified t3 or t4
boolean
C0280280 (UMLS CUI [1])
Gleason score
Item
gleason score 8-10
boolean
C0332326 (UMLS CUI [1])
PSA measurement
Item
prostate-specific antigen (psa) level > 20
boolean
C0201544 (UMLS CUI [1])
Performance status
Item
performance status score of 0-1.
boolean
C1518965 (UMLS CUI [1])
Informed consent
Item
patients must sign a consent form before the start of the study.
boolean
C0021430 (UMLS CUI [1])
Regional disease
Item
no evidence of regional disease: clinically negative regional adenopathies are revealed by imaging (computed axial tomography [cat] scan, magnetic resonance imaging [mri], lymphography) or surgical staging or negative pelvic node dissection.
boolean
C1514819 (UMLS CUI [1])
Distant metastasis
Item
no distant metastasis. these patients must all have a negative bone scan 12 weeks prior to randomization.
boolean
C1269798 (UMLS CUI [1])
Hormonal therapy
Item
hormonal therapy is allowed up to a maximum of two months before the consent form is signed, as long as the initial work-up was done, including having the requested deadlines respected.
boolean
C0279025 (UMLS CUI [1])
Malignancy: disease free survival
Item
patients with a previous history of cancer are eligible on the condition that they have not had any disease progression for more than five years.
boolean
C0006826 (UMLS CUI [1,1])
C0242793 (UMLS CUI [1,2])
Treatment and follow up
Item
the patient must be available for treatments and follow-up visits.
boolean
C0087111 (UMLS CUI [1])
C1522577 (UMLS CUI [2])
Treatment start date
Item
treatments must start in the three weeks following randomization.
boolean
C3173309 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity limiting compliance
Item
severe medical or psychiatric problems that could compromise study compliance.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
ALT and AST
Item
chronic hepatic disease, abnormal hepatic functions, i.e. aspartate aminotransferase, alanine aminotransferase > 1.5 times the upper normal limit.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])

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