ID

31673

Beskrivning

Phase II Study of ASP3550 in Patients With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00568516

Länk

https://clinicaltrials.gov/show/NCT00568516

Nyckelord

Versioner (1)
  1. 2018-09-19 2018-09-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 september 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Prostatic Neoplasms NCT00568516

Engelsk

Eligibility Prostatic Neoplasms NCT00568516

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
Beskrivning

Adenocarcinoma of prostate TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C3258246
is a patient in whom endocrine treatment is indicated. patients with rising serum psa after having prostatectomy or radiotherapy performed with curative intention may be included
Beskrivning

Indication Hormone Therapy | Raised prostate specific antigen Post Prostatectomy Curative | Raised prostate specific antigen Post Therapeutic radiology procedure Curative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0279025
UMLS CUI [2,1]
C0178415
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0033573
UMLS CUI [2,4]
C1276305
UMLS CUI [3,1]
C0178415
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1522449
UMLS CUI [3,4]
C1276305
has a serum testosterone level above 1.5 ng/ml at screening
Beskrivning

Serum testosterone measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0428413
has an ecog (eastern co-operative oncology group) p.s. (performance status) score of 0 to 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous or present endocrine treatment for prostate cancer. however, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months preceding screening visit may be included
Beskrivning

Hormone Therapy Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600139
is being treated with a 5α-reductase inhibitor
Beskrivning

5-alpha Reductase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C2936788
is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
Beskrivning

Patient Appropriate Curative treatment | Patient Appropriate Radical prostatectomy | Patient Appropriate Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1273390
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0194810
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C1522449
has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema
Beskrivning

Severe asthma | Patient need for Inhaled steroids Daily | Anaphylaxis | Urticaria Severe | Angioedema

Datatyp

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C2065041
UMLS CUI [2,3]
C0332173
UMLS CUI [3]
C0002792
UMLS CUI [4,1]
C0042109
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0002994
Tillbaka till toppen

Similar models

Eligibility Prostatic Neoplasms NCT00568516

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate TNM clinical staging
Item
is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
boolean
C0007112 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Indication Hormone Therapy | Raised prostate specific antigen Post Prostatectomy Curative | Raised prostate specific antigen Post Therapeutic radiology procedure Curative
Item
is a patient in whom endocrine treatment is indicated. patients with rising serum psa after having prostatectomy or radiotherapy performed with curative intention may be included
boolean
C3146298 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0033573 (UMLS CUI [2,3])
C1276305 (UMLS CUI [2,4])
C0178415 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C1276305 (UMLS CUI [3,4])
Serum testosterone measurement
Item
has a serum testosterone level above 1.5 ng/ml at screening
boolean
C0428413 (UMLS CUI [1])
ECOG performance status
Item
has an ecog (eastern co-operative oncology group) p.s. (performance status) score of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy Prostate carcinoma
Item
previous or present endocrine treatment for prostate cancer. however, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months preceding screening visit may be included
boolean
C0279025 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
5-alpha Reductase Inhibitors
Item
is being treated with a 5α-reductase inhibitor
boolean
C2936788 (UMLS CUI [1])
Patient Appropriate Curative treatment | Patient Appropriate Radical prostatectomy | Patient Appropriate Therapeutic radiology procedure
Item
is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1273390 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0194810 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
Severe asthma | Patient need for Inhaled steroids Daily | Anaphylaxis | Urticaria Severe | Angioedema
Item
has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema
boolean
C0581126 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C2065041 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0002792 (UMLS CUI [3])
C0042109 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0002994 (UMLS CUI [5])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial