ID

34249

Description

Active Surveillance Magnetic Resonance Imaging Study; ODM derived from: https://clinicaltrials.gov/show/NCT01354171

Link

https://clinicaltrials.gov/show/NCT01354171

Keywords

Versions (1)
  1. 1/15/19 1/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT01354171

English

Eligibility Prostate Cancer NCT01354171

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological confirmation of adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
candidate for active surveillance (favourable risk prostate cancer) as defined by the following:
Description

Patient Appropriate Surveillance | At risk Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0733511
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0600139
clinical stage t1b, t1c, t2a or t2b at the time of diagnosis
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
clinical (diagnostic biopsy) gleason sum < 6
Description

Biopsy Gleason score

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C3203027
psa < 10.0 ng/ml (ug/l)
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy, hormonal therapy (e.g. megestrol, medroxyprogesterone, cyproterone, des), glucocorticoids (except inhaled or topical), lhrh analogues (e.g. leuprolide, goserelin), ketoconazole, non-steroidal antiandrogens (e.g. bicalutamide, flutamide) and/or any 5α-reductase inhibitors within 3 months of randomization
Description

Prior Therapy Prostate carcinoma | Operative Surgical Procedures Except Biopsy | Therapeutic radiology procedure | Hormone Therapy | Megestrol | Medroxyprogesterone | Cyproterone | DES | Glucocorticoids | Exception Glucocorticoids Inhaled | Exception Topical glucocorticoid | LHRH Analog | Leuprolide | Goserelin | Ketoconazole | Nonsteroidal Anti-Androgens | bicalutamide | Flutamide | 5-alpha Reductase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0005558
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0279025
UMLS CUI [5]
C0025175
UMLS CUI [6]
C0025147
UMLS CUI [7]
C0010621
UMLS CUI [8]
C0012203
UMLS CUI [9]
C0017710
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0017710
UMLS CUI [10,3]
C0001559
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0017712
UMLS CUI [12]
C1518041
UMLS CUI [13]
C0085272
UMLS CUI [14]
C0120107
UMLS CUI [15]
C0022625
UMLS CUI [16]
C1320169
UMLS CUI [17]
C0285590
UMLS CUI [18]
C0016384
UMLS CUI [19]
C2936788
planned anti-androgen therapy
Description

Antiandrogen therapy Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C1301732
inability to undergo trus biopsy
Description

Transrectal ultrasound Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0373345
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
inability to undergo multi-parametric mri
Description

Multiparametric MRI Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3898221
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Prostate Cancer NCT01354171

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histological confirmation of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Patient Appropriate Surveillance | At risk Prostate carcinoma
Item
candidate for active surveillance (favourable risk prostate cancer) as defined by the following:
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0733511 (UMLS CUI [1,3])
C1444641 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
TNM clinical staging
Item
clinical stage t1b, t1c, t2a or t2b at the time of diagnosis
boolean
C3258246 (UMLS CUI [1])
Biopsy Gleason score
Item
clinical (diagnostic biopsy) gleason sum < 6
boolean
C0005558 (UMLS CUI [1,1])
C3203027 (UMLS CUI [1,2])
Prostate specific antigen measurement
Item
psa < 10.0 ng/ml (ug/l)
boolean
C0201544 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Prostate carcinoma | Operative Surgical Procedures Except Biopsy | Therapeutic radiology procedure | Hormone Therapy | Megestrol | Medroxyprogesterone | Cyproterone | DES | Glucocorticoids | Exception Glucocorticoids Inhaled | Exception Topical glucocorticoid | LHRH Analog | Leuprolide | Goserelin | Ketoconazole | Nonsteroidal Anti-Androgens | bicalutamide | Flutamide | 5-alpha Reductase Inhibitors
Item
previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy, hormonal therapy (e.g. megestrol, medroxyprogesterone, cyproterone, des), glucocorticoids (except inhaled or topical), lhrh analogues (e.g. leuprolide, goserelin), ketoconazole, non-steroidal antiandrogens (e.g. bicalutamide, flutamide) and/or any 5α-reductase inhibitors within 3 months of randomization
boolean
C1514463 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0005558 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C0025175 (UMLS CUI [5])
C0025147 (UMLS CUI [6])
C0010621 (UMLS CUI [7])
C0012203 (UMLS CUI [8])
C0017710 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0017710 (UMLS CUI [10,2])
C0001559 (UMLS CUI [10,3])
C1705847 (UMLS CUI [11,1])
C0017712 (UMLS CUI [11,2])
C1518041 (UMLS CUI [12])
C0085272 (UMLS CUI [13])
C0120107 (UMLS CUI [14])
C0022625 (UMLS CUI [15])
C1320169 (UMLS CUI [16])
C0285590 (UMLS CUI [17])
C0016384 (UMLS CUI [18])
C2936788 (UMLS CUI [19])
Antiandrogen therapy Planned
Item
planned anti-androgen therapy
boolean
C0279492 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Transrectal ultrasound Receive Unable
Item
inability to undergo trus biopsy
boolean
C0373345 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Multiparametric MRI Receive Unable
Item
inability to undergo multi-parametric mri
boolean
C3898221 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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