ID

36864

Beskrivning

Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2; ODM derived from: https://clinicaltrials.gov/show/NCT02229734

Länk

https://clinicaltrials.gov/show/NCT02229734

Nyckelord

Versioner (1)
  1. 2019-06-17 2019-06-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 juni 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02229734

Engelsk

Eligibility Prostate Cancer NCT02229734

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
high risk prostate cancer
Beskrivning

High risk Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0600139
has had multidisciplinary consultation with radiation oncologist and urologist
Beskrivning

Multidisciplinary assessment Radiation Oncologist Urologist

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0729737
UMLS CUI [1,2]
C1514693
UMLS CUI [1,3]
C0260314
age >70 or refuses standard treatment
Beskrivning

Age | Standard therapy Refused

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C1705116
no evidence of extra-prostatic disease on screening bone scan and ct scan (non-contrast ct used for ct simulation acceptable)
Beskrivning

Disease Extraprostatic Absent Bone scan | Disease Extraprostatic Absent CT scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517078
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C0203668
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1517078
UMLS CUI [2,3]
C0332197
UMLS CUI [2,4]
C0040405
signed written and voluntary informed consent provided.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients not meeting the eligibility criteria
Beskrivning

Inclusion criteria failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0231175
prior pelvic radiotherapy or brachytherapy
Beskrivning

Radiotherapy to pelvis | Brachytherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1536155
UMLS CUI [2]
C0006098
use of anti-coagulation (low molecular weight heparin or coumadin)
Beskrivning

Use of anticoagulation | Heparin, Low-Molecular-Weight | Coumadin

Datatyp

boolean

Alias
UMLS CUI [1]
C0449867
UMLS CUI [2]
C0019139
UMLS CUI [3]
C0699129
history of inflammatory bowel disease, crohn's disease, diverticulitis or collagen vascular disease (other than rheumatoid arthritis)
Beskrivning

Inflammatory Bowel Disease | Crohn Disease | Diverticulitis | Collagen-vascular disease | Exception Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0012813
UMLS CUI [4]
C0262428
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0003873
previous treatment for malignancy (other than basal or squamous cell skin cancer) within 3 years of prostate cancer diagnosis
Beskrivning

Prior Therapy Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
patients on androgen deprivation therapy > 2 months prior to study enrolment
Beskrivning

Antiandrogen therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0279492
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Similar models

Eligibility Prostate Cancer NCT02229734

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
High risk Prostate carcinoma
Item
high risk prostate cancer
boolean
C0332167 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Multidisciplinary assessment Radiation Oncologist Urologist
Item
has had multidisciplinary consultation with radiation oncologist and urologist
boolean
C0729737 (UMLS CUI [1,1])
C1514693 (UMLS CUI [1,2])
C0260314 (UMLS CUI [1,3])
Age | Standard therapy Refused
Item
age >70 or refuses standard treatment
boolean
C0001779 (UMLS CUI [1])
C2936643 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Disease Extraprostatic Absent Bone scan | Disease Extraprostatic Absent CT scan
Item
no evidence of extra-prostatic disease on screening bone scan and ct scan (non-contrast ct used for ct simulation acceptable)
boolean
C0012634 (UMLS CUI [1,1])
C1517078 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0203668 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C1517078 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0040405 (UMLS CUI [2,4])
Informed Consent
Item
signed written and voluntary informed consent provided.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria failed
Item
patients not meeting the eligibility criteria
boolean
C1512693 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Radiotherapy to pelvis | Brachytherapy
Item
prior pelvic radiotherapy or brachytherapy
boolean
C1536155 (UMLS CUI [1])
C0006098 (UMLS CUI [2])
Use of anticoagulation | Heparin, Low-Molecular-Weight | Coumadin
Item
use of anti-coagulation (low molecular weight heparin or coumadin)
boolean
C0449867 (UMLS CUI [1])
C0019139 (UMLS CUI [2])
C0699129 (UMLS CUI [3])
Inflammatory Bowel Disease | Crohn Disease | Diverticulitis | Collagen-vascular disease | Exception Rheumatoid Arthritis
Item
history of inflammatory bowel disease, crohn's disease, diverticulitis or collagen vascular disease (other than rheumatoid arthritis)
boolean
C0021390 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0012813 (UMLS CUI [3])
C0262428 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0003873 (UMLS CUI [5,2])
Prior Therapy Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
previous treatment for malignancy (other than basal or squamous cell skin cancer) within 3 years of prostate cancer diagnosis
boolean
C1514463 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Antiandrogen therapy
Item
patients on androgen deprivation therapy > 2 months prior to study enrolment
boolean
C0279492 (UMLS CUI [1])
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