ID

34357

Descrição

Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02238366

Link

https://clinicaltrials.gov/show/NCT02238366

Palavras-chave

  1. 16/01/2019 16/01/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

16 de janeiro de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT02238366

Eligibility Prostate Cancer NCT02238366

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult men, ≥18 years old, with recently diagnosed locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy as monotherapy or as concomitant and adjuvant therapy in association with radiation therapy, with a 1 or 3 month gnrh analogue triptorelin formulation
Descrição

Adult | Age | Prostate carcinoma Advanced Locally | Metastatic Prostate Carcinoma | Antiandrogen therapy Scheduled | Therapeutic radiology procedure | GnRH Analog | Triptorelin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0600139
UMLS CUI [3,2]
C0205179
UMLS CUI [3,3]
C1517927
UMLS CUI [4]
C0936223
UMLS CUI [5,1]
C0279492
UMLS CUI [5,2]
C0205539
UMLS CUI [6]
C1522449
UMLS CUI [7]
C1518041
UMLS CUI [8]
C0077275
expected survival > 12 months.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
patients having provided written informed consent.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
patients mentally fit for completing a questionnaire.
Descrição

Patients Mentally alert | Questionnaire Completion

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0424536
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any investigational drug within the last 3 months before study entry or planning to participate in a study.
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
patients who already have been treated with a gnrh analogue within the last year.
Descrição

GnRH Analog preceding

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1518041
UMLS CUI [1,2]
C0332152
patients with hypersensitivity to gnrh, gnrh analogue, triptorelin or its excipients.
Descrição

Hypersensitivity GnRH | Hypersensitivity GnRH Analog | Triptorelin allergy | Hypersensitivity GnRH Excipient | Hypersensitivity GnRH Analog Excipient | Hypersensitivity Triptorelin Excipient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0023610
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1518041
UMLS CUI [3]
C0571725
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0023610
UMLS CUI [4,3]
C0015237
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1518041
UMLS CUI [5,3]
C0015237
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0077275
UMLS CUI [6,3]
C0015237
patients with a contraindication according to smpc.
Descrição

Medical contraindication

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1301624

Similar models

Eligibility Prostate Cancer NCT02238366

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | Prostate carcinoma Advanced Locally | Metastatic Prostate Carcinoma | Antiandrogen therapy Scheduled | Therapeutic radiology procedure | GnRH Analog | Triptorelin
Item
adult men, ≥18 years old, with recently diagnosed locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy as monotherapy or as concomitant and adjuvant therapy in association with radiation therapy, with a 1 or 3 month gnrh analogue triptorelin formulation
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0600139 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C0936223 (UMLS CUI [4])
C0279492 (UMLS CUI [5,1])
C0205539 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6])
C1518041 (UMLS CUI [7])
C0077275 (UMLS CUI [8])
Life Expectancy
Item
expected survival > 12 months.
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
patients having provided written informed consent.
boolean
C0021430 (UMLS CUI [1])
Patients Mentally alert | Questionnaire Completion
Item
patients mentally fit for completing a questionnaire.
boolean
C0030705 (UMLS CUI [1,1])
C0424536 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
treatment with any investigational drug within the last 3 months before study entry or planning to participate in a study.
boolean
C0013230 (UMLS CUI [1])
GnRH Analog preceding
Item
patients who already have been treated with a gnrh analogue within the last year.
boolean
C1518041 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
Hypersensitivity GnRH | Hypersensitivity GnRH Analog | Triptorelin allergy | Hypersensitivity GnRH Excipient | Hypersensitivity GnRH Analog Excipient | Hypersensitivity Triptorelin Excipient
Item
patients with hypersensitivity to gnrh, gnrh analogue, triptorelin or its excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0023610 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1518041 (UMLS CUI [2,2])
C0571725 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0023610 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C1518041 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0077275 (UMLS CUI [6,2])
C0015237 (UMLS CUI [6,3])
Medical contraindication
Item
patients with a contraindication according to smpc.
boolean
C1301624 (UMLS CUI [1])

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