ID

22544

Beskrivning

Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00349557

Länk

https://clinicaltrials.gov/show/NCT00349557

Nyckelord

Versioner (1)
  1. 2017-06-07 2017-06-07 -
Uppladdad den

7 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00349557

Engelsk

Eligibility Prostate Cancer NCT00349557

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
high risk prostate cancer as defined as one of the following:
Beskrivning

Prostate carcinoma High risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0332167
1. clinical t2b-t4
Beskrivning

TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1]
C3258246
2. gleason sum score 8-10
Beskrivning

Gleason score

Datatyp

boolean

Alias
UMLS CUI [1]
C3203027
3. psa more than 20 and gleason sum score 7
Beskrivning

Prostate specific antigen measurement | Gleason score

Datatyp

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2]
C3203027
4. in addition, clinical t2a patients are eligible if 5 or more biopsies contain gleason 4+3 cancer (minimum of 10 biopsies total required)
Beskrivning

TNM clinical staging | Biopsy Quantity | Gleason score

Datatyp

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C3203027
no evidence of metastatic disease within 60 days of enrollment, confirmed by physical examination, chest x-ray, bone scan, and computed tomography of the abdomen and pelvis
Beskrivning

Neoplasm Metastasis Absent | Physical Examination | Plain chest X-ray | Bone scan | CT of abdomen | CT of Pelvis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0039985
UMLS CUI [4]
C0203668
UMLS CUI [5]
C0412620
UMLS CUI [6]
C0412628
ecog performance status of 0, 1 or 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer; any major surgery within four weeks, prior hormonal therapy (except finasteride for obstructive voiding symptoms)
Beskrivning

Therapeutic radiology procedure Prostate carcinoma | Cytotoxic therapy Prostate carcinoma | Biological treatment Prostate carcinoma | major surgery | Hormone Therapy | Finasteride | Voiding Symptoms Obstructive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0677881
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C1531518
UMLS CUI [3,2]
C0600139
UMLS CUI [4]
C0679637
UMLS CUI [5]
C0279025
UMLS CUI [6]
C0060389
UMLS CUI [7,1]
C0042034
UMLS CUI [7,2]
C1457887
UMLS CUI [7,3]
C0549186
major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0, anticipation of need for major surgical procedure during the course of the study; minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to day 0
Beskrivning

Major surgery | Incisional biopsy | Traumatic injury | Major surgery Anticipated | Minor Surgical Procedures | Fine needle aspiration biopsy | Core needle biopsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
UMLS CUI [4,1]
C0679637
UMLS CUI [4,2]
C3840775
UMLS CUI [5]
C0038904
UMLS CUI [6]
C1510483
UMLS CUI [7]
C1318309
presence of central nervous system or brain metastases
Beskrivning

CNS metastases | Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220650
blood pressure of >150/100 mmhg
Beskrivning

Blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C1271104
history of myocardial infarction within 6 months
Beskrivning

Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
history of stroke within 6 months
Beskrivning

Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a genentech-sponsored bevacizumab cancer study
Beskrivning

Study Subject Participation Status | Investigational New Drugs | bevacizumab

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0796392
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Similar models

Eligibility Prostate Cancer NCT00349557

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma High risk
Item
high risk prostate cancer as defined as one of the following:
boolean
C0600139 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
TNM clinical staging
Item
1. clinical t2b-t4
boolean
C3258246 (UMLS CUI [1])
Gleason score
Item
2. gleason sum score 8-10
boolean
C3203027 (UMLS CUI [1])
Prostate specific antigen measurement | Gleason score
Item
3. psa more than 20 and gleason sum score 7
boolean
C0201544 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
TNM clinical staging | Biopsy Quantity | Gleason score
Item
4. in addition, clinical t2a patients are eligible if 5 or more biopsies contain gleason 4+3 cancer (minimum of 10 biopsies total required)
boolean
C3258246 (UMLS CUI [1])
C0005558 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C3203027 (UMLS CUI [3])
Neoplasm Metastasis Absent | Physical Examination | Plain chest X-ray | Bone scan | CT of abdomen | CT of Pelvis
Item
no evidence of metastatic disease within 60 days of enrollment, confirmed by physical examination, chest x-ray, bone scan, and computed tomography of the abdomen and pelvis
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2])
C0039985 (UMLS CUI [3])
C0203668 (UMLS CUI [4])
C0412620 (UMLS CUI [5])
C0412628 (UMLS CUI [6])
ECOG performance status
Item
ecog performance status of 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure Prostate carcinoma | Cytotoxic therapy Prostate carcinoma | Biological treatment Prostate carcinoma | major surgery | Hormone Therapy | Finasteride | Voiding Symptoms Obstructive
Item
concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer; any major surgery within four weeks, prior hormonal therapy (except finasteride for obstructive voiding symptoms)
boolean
C1522449 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0677881 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C1531518 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
C0679637 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C0060389 (UMLS CUI [6])
C0042034 (UMLS CUI [7,1])
C1457887 (UMLS CUI [7,2])
C0549186 (UMLS CUI [7,3])
Major surgery | Incisional biopsy | Traumatic injury | Major surgery Anticipated | Minor Surgical Procedures | Fine needle aspiration biopsy | Core needle biopsy
Item
major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0, anticipation of need for major surgical procedure during the course of the study; minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to day 0
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C0679637 (UMLS CUI [4,1])
C3840775 (UMLS CUI [4,2])
C0038904 (UMLS CUI [5])
C1510483 (UMLS CUI [6])
C1318309 (UMLS CUI [7])
CNS metastases | Metastatic malignant neoplasm to brain
Item
presence of central nervous system or brain metastases
boolean
C0686377 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
Blood pressure
Item
blood pressure of >150/100 mmhg
boolean
C1271104 (UMLS CUI [1])
Myocardial Infarction
Item
history of myocardial infarction within 6 months
boolean
C0027051 (UMLS CUI [1])
Cerebrovascular accident
Item
history of stroke within 6 months
boolean
C0038454 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | bevacizumab
Item
current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a genentech-sponsored bevacizumab cancer study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0796392 (UMLS CUI [3])
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