ID

36880

Description

MR-guided Focal Laser Ablation of the Prostate; ODM derived from: https://clinicaltrials.gov/show/NCT02200809

Link

https://clinicaltrials.gov/show/NCT02200809

Keywords

Versions (1)
  1. 6/18/19 6/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02200809

English

Eligibility Prostate Cancer NCT02200809

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed and biopsy proven prostate cancer
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
intermediate risk patients (psa <= 20 ng/ml, gleason ≤ 7, t2b)
Description

Patients Intermediate Risk | Prostate specific antigen measurement | Gleason score | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3640764
UMLS CUI [2]
C0201544
UMLS CUI [3]
C3203027
UMLS CUI [4]
C3258246
no previous treatment for prostate cancer
Description

Prostate carcinoma Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0332155
cancer lesion located at least 1 cm away from the neurovascular bundle according to multimodality mr images
Description

Neoplasm Lesion | Location With distance Neurovascular bundle Multimodal Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0221198
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C2979906
UMLS CUI [2,3]
C0824497
UMLS CUI [2,4]
C1513743
signed informed consent by patient
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
age 18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia)
Description

Screening form Signed | Exclusion Metal device | Exclusion Foreign Bodies | Exclusion Claustrophobia

Data type

boolean

Alias
UMLS CUI [1,1]
C3173811
UMLS CUI [1,2]
C1519316
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0336536
UMLS CUI [3,1]
C2828389
UMLS CUI [3,2]
C0016542
UMLS CUI [4,1]
C2828389
UMLS CUI [4,2]
C0008909
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
impossibility to obtain a valid informed consent
Description

Informed Consent Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
patients unable to undergo mr imaging, including those with contra-indications
Description

MRI Receive Unable | Medical contraindication MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0024485
contra-indications to mr guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection)
Description

Medical contraindication Laser Therapy Focal | Ulcerative Colitis | Rectal Diseases | Abdominoperineal resection

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1955835
UMLS CUI [1,3]
C0205234
UMLS CUI [2]
C0009324
UMLS CUI [3]
C0034882
UMLS CUI [4]
C2004459
metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of mr imaging
Description

Hip Implant Metallic | Metallic device / implant distorts Magnetic Field | Metallic device / implant compromises Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0019560
UMLS CUI [1,2]
C2986473
UMLS CUI [2,1]
C3693688
UMLS CUI [2,2]
C0700135
UMLS CUI [2,3]
C0563533
UMLS CUI [3,1]
C3693688
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0024485
patients with evidence for nodal or metastatic disease
Description

Disorder of lymph node | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0272394
UMLS CUI [2]
C0027627
patients with an estimated glomerular filtration ratio (egfr) < 40 ml/min/1.73 m2
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
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Similar models

Eligibility Prostate Cancer NCT02200809

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma
Item
newly diagnosed and biopsy proven prostate cancer
boolean
C0600139 (UMLS CUI [1])
Patients Intermediate Risk | Prostate specific antigen measurement | Gleason score | TNM clinical staging
Item
intermediate risk patients (psa <= 20 ng/ml, gleason ≤ 7, t2b)
boolean
C0030705 (UMLS CUI [1,1])
C3640764 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2])
C3203027 (UMLS CUI [3])
C3258246 (UMLS CUI [4])
Prostate carcinoma Untreated
Item
no previous treatment for prostate cancer
boolean
C0600139 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Neoplasm Lesion | Location With distance Neurovascular bundle Multimodal Imaging
Item
cancer lesion located at least 1 cm away from the neurovascular bundle according to multimodality mr images
boolean
C0027651 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C2979906 (UMLS CUI [2,2])
C0824497 (UMLS CUI [2,3])
C1513743 (UMLS CUI [2,4])
Informed Consent
Item
signed informed consent by patient
boolean
C0021430 (UMLS CUI [1])
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Screening form Signed | Exclusion Metal device | Exclusion Foreign Bodies | Exclusion Claustrophobia
Item
signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia)
boolean
C3173811 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C2828389 (UMLS CUI [2,1])
C0336536 (UMLS CUI [2,2])
C2828389 (UMLS CUI [3,1])
C0016542 (UMLS CUI [3,2])
C2828389 (UMLS CUI [4,1])
C0008909 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Lacking
Item
impossibility to obtain a valid informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
MRI Receive Unable | Medical contraindication MRI
Item
patients unable to undergo mr imaging, including those with contra-indications
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Medical contraindication Laser Therapy Focal | Ulcerative Colitis | Rectal Diseases | Abdominoperineal resection
Item
contra-indications to mr guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection)
boolean
C1301624 (UMLS CUI [1,1])
C1955835 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,3])
C0009324 (UMLS CUI [2])
C0034882 (UMLS CUI [3])
C2004459 (UMLS CUI [4])
Hip Implant Metallic | Metallic device / implant distorts Magnetic Field | Metallic device / implant compromises Magnetic Resonance Imaging
Item
metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of mr imaging
boolean
C0019560 (UMLS CUI [1,1])
C2986473 (UMLS CUI [1,2])
C3693688 (UMLS CUI [2,1])
C0700135 (UMLS CUI [2,2])
C0563533 (UMLS CUI [2,3])
C3693688 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
Disorder of lymph node | Neoplasm Metastasis
Item
patients with evidence for nodal or metastatic disease
boolean
C0272394 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Estimated Glomerular Filtration Rate
Item
patients with an estimated glomerular filtration ratio (egfr) < 40 ml/min/1.73 m2
boolean
C3811844 (UMLS CUI [1])
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