ID

36881

Description

Focal Prostate Radio-Frequency Ablation; ODM derived from: https://clinicaltrials.gov/show/NCT02328807

Link

https://clinicaltrials.gov/show/NCT02328807

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 NCT02328807

English

Eligibility Prostate Cancer NCT02328807

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men 18 years of age or older
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
diagnosis of adenocarcinoma of the prostate, confirmed by h.l. moffitt cancer center review
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
no prior treatment for prostate cancer
Description

Prostate carcinoma Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0332155
eastern cooperative oncology group (ecog) performance status of 0 or1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
prostate cancer clinical stage t2a and below
Description

Prostate carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C3258246
psa <10 ng/ml (this will be the prostatic specific antigen (psa) level prompting the initial prostate biopsy)
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
prostate size <60 cc on transrectal ultrasound
Description

Size of prostate TRUS

Data type

boolean

Alias
UMLS CUI [1,1]
C1287816
UMLS CUI [1,2]
C0373345
pre-enrollment biopsy parameters (as per h.l. moffitt c.c. review): minimum of 10 biopsy cores; no primary pattern biopsy gleason grade 4 or 5; unilateral cancer (only right-sided or left-sided, not bilateral); no more than 1 core with 50% cancer; no more than 4 cores with positive biopsies with gleason pattern 3 + 3 and no more than 2 cores with positive biopsies containing gleason pattern 3 + 4.
Description

Biopsy Parameters | Status pre- Enrollment | Core biopsy Quantity Minimum | Primary Gleason pattern | Neoplasm Unilateral | Neoplasm Percentage Core biopsy | Core biopsy Positive Quantity Gleason pattern

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0449381
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C1516879
UMLS CUI [3,1]
C1318309
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C1524031
UMLS CUI [4]
C1273604
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C0205092
UMLS CUI [6,1]
C0027651
UMLS CUI [6,2]
C0439165
UMLS CUI [6,3]
C1318309
UMLS CUI [7,1]
C1318309
UMLS CUI [7,2]
C1514241
UMLS CUI [7,3]
C1265611
UMLS CUI [7,4]
C1273606
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
men less than 18 years of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
medically unfit for anesthesia
Description

Medically unfit Anesthesia

Data type

boolean

Alias
UMLS CUI [1,1]
C3841806
UMLS CUI [1,2]
C0002903
histology other than adenocarcinoma
Description

Histology | Exception Adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0344441
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001418
biopsy does not meet inclusion criteria
Description

Biopsy Inclusion criteria failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1512693
UMLS CUI [1,3]
C0231175
men who have received any hormonal manipulation (antiandrogens; luteinizing hormone releasing hormone (lhrh) agonist; 5-alpha-reductase inhibitors) within the previous 6 months
Description

Gender Hormone manipulation | Androgen Antagonists | LHRH Agonist | 5-alpha Reductase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0586971
UMLS CUI [2]
C0002842
UMLS CUI [3]
C1518041
UMLS CUI [4]
C2936788
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Similar models

Eligibility Prostate Cancer NCT02328807

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
men 18 years of age or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Adenocarcinoma of prostate
Item
diagnosis of adenocarcinoma of the prostate, confirmed by h.l. moffitt cancer center review
boolean
C0007112 (UMLS CUI [1])
Prostate carcinoma Untreated
Item
no prior treatment for prostate cancer
boolean
C0600139 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or1
boolean
C1520224 (UMLS CUI [1])
Prostate carcinoma TNM clinical staging
Item
prostate cancer clinical stage t2a and below
boolean
C0600139 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Prostate specific antigen measurement
Item
psa <10 ng/ml (this will be the prostatic specific antigen (psa) level prompting the initial prostate biopsy)
boolean
C0201544 (UMLS CUI [1])
Size of prostate TRUS
Item
prostate size <60 cc on transrectal ultrasound
boolean
C1287816 (UMLS CUI [1,1])
C0373345 (UMLS CUI [1,2])
Biopsy Parameters | Status pre- Enrollment | Core biopsy Quantity Minimum | Primary Gleason pattern | Neoplasm Unilateral | Neoplasm Percentage Core biopsy | Core biopsy Positive Quantity Gleason pattern
Item
pre-enrollment biopsy parameters (as per h.l. moffitt c.c. review): minimum of 10 biopsy cores; no primary pattern biopsy gleason grade 4 or 5; unilateral cancer (only right-sided or left-sided, not bilateral); no more than 1 core with 50% cancer; no more than 4 cores with positive biopsies with gleason pattern 3 + 3 and no more than 2 cores with positive biopsies containing gleason pattern 3 + 4.
boolean
C0005558 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C1516879 (UMLS CUI [2,2])
C1318309 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1524031 (UMLS CUI [3,3])
C1273604 (UMLS CUI [4])
C0027651 (UMLS CUI [5,1])
C0205092 (UMLS CUI [5,2])
C0027651 (UMLS CUI [6,1])
C0439165 (UMLS CUI [6,2])
C1318309 (UMLS CUI [6,3])
C1318309 (UMLS CUI [7,1])
C1514241 (UMLS CUI [7,2])
C1265611 (UMLS CUI [7,3])
C1273606 (UMLS CUI [7,4])
Item Group
C0680251 (UMLS CUI)
Gender | Age
Item
men less than 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Medically unfit Anesthesia
Item
medically unfit for anesthesia
boolean
C3841806 (UMLS CUI [1,1])
C0002903 (UMLS CUI [1,2])
Histology | Exception Adenocarcinoma
Item
histology other than adenocarcinoma
boolean
C0344441 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0001418 (UMLS CUI [2,2])
Biopsy Inclusion criteria failed
Item
biopsy does not meet inclusion criteria
boolean
C0005558 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Gender Hormone manipulation | Androgen Antagonists | LHRH Agonist | 5-alpha Reductase Inhibitors
Item
men who have received any hormonal manipulation (antiandrogens; luteinizing hormone releasing hormone (lhrh) agonist; 5-alpha-reductase inhibitors) within the previous 6 months
boolean
C0079399 (UMLS CUI [1,1])
C0586971 (UMLS CUI [1,2])
C0002842 (UMLS CUI [2])
C1518041 (UMLS CUI [3])
C2936788 (UMLS CUI [4])
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