ID

36967

Descrizione

Standard Dose Versus High Dose and Versus Extended Standard Dose Radium-223 Dichloride in Castration-resistant Prostate Cancer Metastatic to the Bone; ODM derived from: https://clinicaltrials.gov/show/NCT02023697

collegamento

https://clinicaltrials.gov/show/NCT02023697

Keywords

versioni (1)
  1. 24/06/19 24/06/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

24 giugno 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Prostatic Neoplasms NCT02023697

Inglese

Eligibility Prostatic Neoplasms NCT02023697

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma of the prostate
Descrizione

Adenocarcinoma of prostate

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0007112
castration-resistant disease defined as:
Descrizione

Hormone refractory prostate cancer

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1328504
serum testosterone level: ≤ 50 ng/dl (1.7 nmol/l)
Descrizione

Serum testosterone measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0428413
bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (lhrh) agonist or antagonist, or polyestradiol phosphate
Descrizione

Male Castration | Maintenance Androgen suppression | Luteinizing Hormone-releasing Hormone Agonist | Luteinizing hormone releasing hormone antagonist product | polyestradiol phosphate

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0007347
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C1515985
UMLS CUI [3]
C1518041
UMLS CUI [4]
C1276926
UMLS CUI [5]
C0071554
serum psa (prostate specific antigen) progression defined as 2 subsequent increases in psa over a previous reference value (a minimum of 2 ng/ml [μg/l]) or
Descrizione

Raised prostate specific antigen Quantity | Prostate specific antigen measurement

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0201544
radiographic evidence of disease progression in bone (according to prostate cancer clinical trials working group 2 [pcwg2] criteria) with or without psa progression
Descrizione

Disease Progression Bone Radiography | Raised prostate specific antigen | Raised prostate specific antigen Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0262950
UMLS CUI [1,3]
C0034571
UMLS CUI [2]
C0178415
UMLS CUI [3,1]
C0178415
UMLS CUI [3,2]
C0332197
eastern cooperative oncology group performance status (ecog ps) 0 to 2. in case of ecog ps 2, the ps has to be due to metastatic prostate cancer to the bone.
Descrizione

ECOG performance status | Relationship Prostate cancer metastatic to bone

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C4076671
two or more skeletal metastases (≥ 2 hot spots) on bone scintigraphy within 8 weeks of randomization
Descrizione

Neoplasm Metastasis Skeletal Quantity | Hot spot Quantity Bone scintigraphy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0521324
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3829661
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C3889015
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of visceral metastasis, or visceral metastases
Descrizione

Neoplasm Metastasis Visceral

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
Descrizione

Lymphadenopathy | Lymph nodes Diameter Short axis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0497156
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0522488
central nervous system (cns) metastases
Descrizione

CNS metastases

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0686377
treatment with cytotoxic chemotherapy for prostate cancer within the previous 4 weeks prior to randomization, or planned treatment with cytotoxic chemotherapy agents for prostate cancer during the treatment period or follow-up
Descrizione

Cytotoxic Chemotherapy Prostate carcinoma | Cytotoxic Chemotherapy Planned Prostate carcinoma

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0677881
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C0600139
chronic conditions associated with non-malignant abnormal bone growth (e.g. confirmed paget's disease of bone)
Descrizione

Chronic condition Associated with Abnormal bone growth | Osteitis Deformans

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C4315615
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0005941
UMLS CUI [2]
C0029401
prior treatment with radium-223 dichloride
Descrizione

Radium-223 dichloride

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3541342
prior systemic radiotherapy and hemibody external radiotherapy
Descrizione

Therapeutic radiology procedure Systemic | Teleradiotherapy procedure Hemibody

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0419095
UMLS CUI [2,2]
C3846139
Ritorna all'inizio della pagina

Similar models

Eligibility Prostatic Neoplasms NCT02023697

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically or cytologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Hormone refractory prostate cancer
Item
castration-resistant disease defined as:
boolean
C1328504 (UMLS CUI [1])
Serum testosterone measurement
Item
serum testosterone level: ≤ 50 ng/dl (1.7 nmol/l)
boolean
C0428413 (UMLS CUI [1])
Male Castration | Maintenance Androgen suppression | Luteinizing Hormone-releasing Hormone Agonist | Luteinizing hormone releasing hormone antagonist product | polyestradiol phosphate
Item
bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (lhrh) agonist or antagonist, or polyestradiol phosphate
boolean
C0007347 (UMLS CUI [1])
C0024501 (UMLS CUI [2,1])
C1515985 (UMLS CUI [2,2])
C1518041 (UMLS CUI [3])
C1276926 (UMLS CUI [4])
C0071554 (UMLS CUI [5])
Raised prostate specific antigen Quantity | Prostate specific antigen measurement
Item
serum psa (prostate specific antigen) progression defined as 2 subsequent increases in psa over a previous reference value (a minimum of 2 ng/ml [μg/l]) or
boolean
C0178415 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2])
Disease Progression Bone Radiography | Raised prostate specific antigen | Raised prostate specific antigen Absent
Item
radiographic evidence of disease progression in bone (according to prostate cancer clinical trials working group 2 [pcwg2] criteria) with or without psa progression
boolean
C0242656 (UMLS CUI [1,1])
C0262950 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C0178415 (UMLS CUI [2])
C0178415 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
ECOG performance status | Relationship Prostate cancer metastatic to bone
Item
eastern cooperative oncology group performance status (ecog ps) 0 to 2. in case of ecog ps 2, the ps has to be due to metastatic prostate cancer to the bone.
boolean
C1520224 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C4076671 (UMLS CUI [2,2])
Neoplasm Metastasis Skeletal Quantity | Hot spot Quantity Bone scintigraphy
Item
two or more skeletal metastases (≥ 2 hot spots) on bone scintigraphy within 8 weeks of randomization
boolean
C0027627 (UMLS CUI [1,1])
C0521324 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3829661 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C3889015 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis Visceral
Item
history of visceral metastasis, or visceral metastases
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
Lymphadenopathy | Lymph nodes Diameter Short axis
Item
lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
boolean
C0497156 (UMLS CUI [1])
C0024204 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0522488 (UMLS CUI [2,3])
CNS metastases
Item
central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Cytotoxic Chemotherapy Prostate carcinoma | Cytotoxic Chemotherapy Planned Prostate carcinoma
Item
treatment with cytotoxic chemotherapy for prostate cancer within the previous 4 weeks prior to randomization, or planned treatment with cytotoxic chemotherapy agents for prostate cancer during the treatment period or follow-up
boolean
C0677881 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0677881 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
Chronic condition Associated with Abnormal bone growth | Osteitis Deformans
Item
chronic conditions associated with non-malignant abnormal bone growth (e.g. confirmed paget's disease of bone)
boolean
C4315615 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0005941 (UMLS CUI [1,3])
C0029401 (UMLS CUI [2])
Radium-223 dichloride
Item
prior treatment with radium-223 dichloride
boolean
C3541342 (UMLS CUI [1])
Therapeutic radiology procedure Systemic | Teleradiotherapy procedure Hemibody
Item
prior systemic radiotherapy and hemibody external radiotherapy
boolean
C1522449 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0419095 (UMLS CUI [2,1])
C3846139 (UMLS CUI [2,2])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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