Informações:
Falhas:
ID
13367
Descrição
Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01122121
Link
https://clinicaltrials.gov/show/NCT01122121
Palavras-chave
Versões (1)
- 09/02/2016 09/02/2016 -
Transferido a
9 de fevereiro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms, Locally Advanced NCT01122121
Eligibility Prostatic Neoplasms, Locally Advanced NCT01122121
- StudyEvent: Eligibility
Similar models
Eligibility Prostatic Neoplasms, Locally Advanced NCT01122121
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
prostate adenocarcinoma
Item
histologically confirmed locally advanced adenocarcinoma of the prostate, graded: t3 or t4 or pt3 on biopsies (presence of tumour tissue in periprostatic fat observed on biopsies), n0 (absence of metastatic), m0 (no distant metastases detectable on the following examinations: bone scan, chest x-ray, abdominal and pelvic ultrasound).
boolean
C0007112 (UMLS CUI [1])
C1300072 (UMLS CUI [2])
C1300072 (UMLS CUI [2])
therapy
Item
patient in whom the prostatic adenocarcinoma has received no prior treatment of any type, with the possible exception of transurethral resection due to obstructive symptoms.
boolean
C0087111 (UMLS CUI [1])
karnofsky
Item
patient with a karnofsky index greater than or equal to (≥) 70.
boolean
C0206065 (UMLS CUI [1])
age
Item
patient aged under 80 years on the randomization date.
boolean
C0001779 (UMLS CUI [1])
life expectancy
Item
patient with a life expectancy of at least 7 years.
boolean
C0023671 (UMLS CUI [1])
consent
Item
patient who, after having received clear information, gave his written consent to participate and cooperate in the study.
boolean
C0021430 (UMLS CUI [1])
transaminases
Item
patient for whom a recent blood test (less than [<] 2 months) has not revealed elevated transaminases ≥ 3 times the normal laboratory range.
boolean
C0002594 (UMLS CUI [1])
informed consent
Item
patient incapable of understanding the information supplied concerning the study or of giving his consent, or having refused to sign the informed consent form,
boolean
C0021430 (UMLS CUI [1])
compliance
Item
patient for whom there is a risk that follow-up in compliance with the conditions stipulated by the protocol will not be possible,
boolean
C1321605 (UMLS CUI [1])
therapy
Item
patient having already received prior treatment for prostate cancer, excluding transurethral resection of the prostate to relieve obstruction,
boolean
C0087111 (UMLS CUI [1])
surgical castration
Item
patient having undergone surgical castration, or with a history of bilateral adrenalectomy or hypophysectomy,
boolean
C0007347 (UMLS CUI [1])
cancer
Item
patient having had another cancer within the previous 5 years (including carcinoma in situ of the bladder) excluding basocellular epithelioma or carcinoma in situ (other than in the bladder),
boolean
C0006826 (UMLS CUI [1])
metastasis
Item
patient with lymph node or metastatic spread of the prostatic adenocarcinoma suspected on imaging,
boolean
C0027627 (UMLS CUI [1])
comorbidity
Item
patient with a non-controlled severe active disease,
boolean
C0009488 (UMLS CUI [1])
contraindication
Item
patient with a contraindication to external prostatic radiotherapy,
boolean
C1301624 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,2])
study subject participation status
Item
patient receiving or having received another experimental treatment within 3 months prior to inclusion in the study,
boolean
C2348568 (UMLS CUI [1])
liver dysfunction
Item
patient with impaired liver function or elevated transaminases ≥3 times the normal laboratory range.
boolean
C0086565 (UMLS CUI [1])