ID

31625

Beskrivning

Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00895466

Länk

https://clinicaltrials.gov/show/NCT00895466

Nyckelord

Versioner (1)
  1. 2018-09-14 2018-09-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 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 Prostate Cancer NCT00895466

Engelsk

Eligibility Prostate Cancer NCT00895466

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathological confirmed prostatic adenocarcinoma, clinical stage (c) ct1-3, cn0-1/x, cm0
Beskrivning

Adenocarcinoma of prostate TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C3258246
baseline testosterone levels of > 4 nmol/l
Beskrivning

Testosterone measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0523912
baseline psa level of > 10 microg/l
Beskrivning

Prostate specific antigen measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201544
eligible for hormone therapy
Beskrivning

Eligibility Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0279025
willingness to comply with the protocol conditions and procedures
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
willing and able to give informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinical evidence of distant metastases
Beskrivning

Distant metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C1269798
previous hormonal therapy administered specifically for prostatic carcinoma
Beskrivning

Prior Hormone Therapy Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C0600139
development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin
Beskrivning

Invasive cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datatyp

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications
Beskrivning

Primary immunodeficiency | Secondary immunodeficiency | Immunosuppression | Adrenal Cortex Hormones | Immunosuppressive Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0398686
UMLS CUI [2]
C0398795
UMLS CUI [3]
C4048329
UMLS CUI [4]
C0001617
UMLS CUI [5]
C0021081
concomitant administration - or administration during the 12 weeks preceding study inclusion - of immune enhancing medication or testosterone supplements
Beskrivning

Immunologic Adjuvants | Testosterone Supplement

Datatyp

boolean

Alias
UMLS CUI [1]
C0001551
UMLS CUI [2,1]
C0039601
UMLS CUI [2,2]
C2348609
concomitant radiotherapy for prostate cancer
Beskrivning

Therapeutic radiology procedure Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0600139
presence of bacterial prostatitis causing a psa increase during the 8 weeks preceding study inclusion
Beskrivning

Bacterial prostatitis Causing Raised prostate specific antigen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0748023
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0178415
simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrollment into the present study
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
bmi > 30 kg/square meter
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
previous serious reaction to a vaccine such as angioedema or anaphylaxis
Beskrivning

Reaction Serious Vaccines | Angioedema | Anaphylaxis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0443286
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0042210
UMLS CUI [2]
C0002994
UMLS CUI [3]
C0002792
Tillbaka till toppen

Similar models

Eligibility Prostate Cancer NCT00895466

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate TNM clinical staging
Item
pathological confirmed prostatic adenocarcinoma, clinical stage (c) ct1-3, cn0-1/x, cm0
boolean
C0007112 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Testosterone measurement
Item
baseline testosterone levels of > 4 nmol/l
boolean
C0523912 (UMLS CUI [1])
Prostate specific antigen measurement
Item
baseline psa level of > 10 microg/l
boolean
C0201544 (UMLS CUI [1])
Eligibility Hormone Therapy
Item
eligible for hormone therapy
boolean
C1548635 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
Protocol Compliance
Item
willingness to comply with the protocol conditions and procedures
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
willing and able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Distant metastasis
Item
clinical evidence of distant metastases
boolean
C1269798 (UMLS CUI [1])
Prior Hormone Therapy Prostate carcinoma
Item
previous hormonal therapy administered specifically for prostatic carcinoma
boolean
C1514460 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Invasive cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Primary immunodeficiency | Secondary immunodeficiency | Immunosuppression | Adrenal Cortex Hormones | Immunosuppressive Agents
Item
primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications
boolean
C0398686 (UMLS CUI [1])
C0398795 (UMLS CUI [2])
C4048329 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
C0021081 (UMLS CUI [5])
Immunologic Adjuvants | Testosterone Supplement
Item
concomitant administration - or administration during the 12 weeks preceding study inclusion - of immune enhancing medication or testosterone supplements
boolean
C0001551 (UMLS CUI [1])
C0039601 (UMLS CUI [2,1])
C2348609 (UMLS CUI [2,2])
Therapeutic radiology procedure Prostate carcinoma
Item
concomitant radiotherapy for prostate cancer
boolean
C1522449 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Bacterial prostatitis Causing Raised prostate specific antigen
Item
presence of bacterial prostatitis causing a psa increase during the 8 weeks preceding study inclusion
boolean
C0748023 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0178415 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrollment into the present study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Body mass index
Item
bmi > 30 kg/square meter
boolean
C1305855 (UMLS CUI [1])
Reaction Serious Vaccines | Angioedema | Anaphylaxis
Item
previous serious reaction to a vaccine such as angioedema or anaphylaxis
boolean
C0443286 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0002994 (UMLS CUI [2])
C0002792 (UMLS CUI [3])
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