ID

31622

Beschrijving

Prostate Conformal Cryotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00877682

Link

https://clinicaltrials.gov/show/NCT00877682

Trefwoorden

Versies (1)
  1. 13-09-18 13-09-18 -
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See clinicaltrials.gov

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13 september 2018

DOI

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Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00877682

Engels

Eligibility Prostate Cancer NCT00877682

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically identified adenocarcinoma of the prostate by minimum 6 core prostate biopsy.
Beschrijving

Adenocarcinoma of prostate | Core needle biopsy of prostate Quantity Minimum

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2,1]
C0194806
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1524031
2. serum psa </= 10 ng/ml before prostate biopsy
Beschrijving

Prostate specific antigen measurement | Status pre- Biopsy of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0194804
3. less than 50% of samples from one side of the prostate positive for prostate cancer.
Beschrijving

Specimen from prostate Percentage Positive Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0586596
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1514241
UMLS CUI [1,4]
C0600139
4. no greater than 50% of a single core total length occupied by prostate cancer.
Beschrijving

Core Length Involvement with Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0444669
UMLS CUI [1,2]
C1444754
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0600139
5. no dominant gleason 4 component. (e.g.; 4+x is not allowed, but x+4 is eligible)
Beschrijving

Gleason Grading System

Datatype

boolean

Alias
UMLS CUI [1]
C0332326
6. no gleason 5 component (primary, secondary or tertiary).
Beschrijving

Gleason Grading System | Primary Gleason pattern | Secondary Gleason pattern | Tertiary Gleason pattern

Datatype

boolean

Alias
UMLS CUI [1]
C0332326
UMLS CUI [2]
C1273604
UMLS CUI [3]
C1273605
UMLS CUI [4]
C1273608
7. subjects may have contralateral positive prostate biopsy in a single core within the eligibility biopsy so long as the involvement of this core is 2mm or less and no gleason 4 or gleason 5 pattern exists. this is considered to be non-dominant (contralateral) tumor burden and is not exclusionary.
Beschrijving

Core Prostate biopsy Contralateral Positive | Core Involvement Length | Gleason pattern Number Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0444669
UMLS CUI [1,2]
C0194804
UMLS CUI [1,3]
C0441988
UMLS CUI [1,4]
C1514241
UMLS CUI [2,1]
C0444669
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C1444754
UMLS CUI [3,1]
C1273606
UMLS CUI [3,2]
C0237753
UMLS CUI [3,3]
C0332197
8. in the case that the confirmatory biopsy fails to sample the tumor again, patients will be allowed to continue into the therapeutic phase using the laterality information obtained during the eligibility biopsy.
Beschrijving

Biopsy Tumor tissue sample failed | Therapeutic procedure Continued

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0475358
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0549178
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. medical history or concurrent disease which in the investigators mind places the patient at significant preoperative risk or for which the investigator does not feel this therapy is appropriate. investigator believes subject is unwilling or unable to comply with study protocol requirements.
Beschrijving

Medical History Risk Preoperative | Comorbidity Risk Preoperative | Medical History Therapeutic procedure Inappropriate | Comorbidity Therapeutic procedure Inappropriate | Protocol Compliance Unwilling | Protocol Compliance Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0445204
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0445204
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C1548788
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C1548788
UMLS CUI [5,1]
C0525058
UMLS CUI [5,2]
C0558080
UMLS CUI [6,1]
C0525058
UMLS CUI [6,2]
C1299582
2. auasi (american urologic association symptom index) score >/=20
Beschrijving

Symptom score [AUASI]

Datatype

boolean

Alias
UMLS CUI [1]
C4265843
3. active urinary tract infection
Beschrijving

Urinary tract infection

Datatype

boolean

Alias
UMLS CUI [1]
C0042029
4. active treatment with anticoagulant/anti-platelet agent that cannot be safely stopped at the time of prostate biopsy and cryotherapy.
Beschrijving

Anticoagulant therapy | Antiplatelet therapy | Anticoagulants Discontinue Unsuccessful | Antiplatelet Agents Discontinue Unsuccessful | Biopsy of prostate | Cold Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0150457
UMLS CUI [2]
C1096021
UMLS CUI [3,1]
C0003280
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C1272705
UMLS CUI [4,1]
C0085826
UMLS CUI [4,2]
C1444662
UMLS CUI [4,3]
C1272705
UMLS CUI [5]
C0194804
UMLS CUI [6]
C0010412
5. medical or surgical castration initiated before or after the eligibility biopsy.
Beschrijving

Medical Castration Initiation Before Biopsy | Male Castration Initiation Before Biopsy | Medical Castration Initiation Post Biopsy | Male Castration Initiation Post Biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513054
UMLS CUI [1,2]
C1704686
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0005558
UMLS CUI [2,1]
C0007347
UMLS CUI [2,2]
C1704686
UMLS CUI [2,3]
C0332152
UMLS CUI [2,4]
C0005558
UMLS CUI [3,1]
C1513054
UMLS CUI [3,2]
C1704686
UMLS CUI [3,3]
C0687676
UMLS CUI [3,4]
C0005558
UMLS CUI [4,1]
C0007347
UMLS CUI [4,2]
C1704686
UMLS CUI [4,3]
C0687676
UMLS CUI [4,4]
C0005558
6. patient is unable to provide informed consent.
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
7. patients will undergo base line bone scan prior to cryoablation to evaluate for regions of abnormal uptake before therapeutic intervention. metastatic disease by bone scintigraphy is exclusionary. bone scans performed within 12 months prior to study entry will be used for study base line purposes and will not need to be repeated, unless clinically indicated.
Beschrijving

Bone scan Before Cryosurgery | Neoplasm Metastasis Bone scintigraphy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0203668
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0010408
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C3889015
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Similar models

Eligibility Prostate Cancer NCT00877682

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate | Core needle biopsy of prostate Quantity Minimum
Item
1. histologically identified adenocarcinoma of the prostate by minimum 6 core prostate biopsy.
boolean
C0007112 (UMLS CUI [1])
C0194806 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1524031 (UMLS CUI [2,3])
Prostate specific antigen measurement | Status pre- Biopsy of prostate
Item
2. serum psa </= 10 ng/ml before prostate biopsy
boolean
C0201544 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0194804 (UMLS CUI [2,2])
Specimen from prostate Percentage Positive Prostate carcinoma
Item
3. less than 50% of samples from one side of the prostate positive for prostate cancer.
boolean
C0586596 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0600139 (UMLS CUI [1,4])
Core Length Involvement with Prostate carcinoma
Item
4. no greater than 50% of a single core total length occupied by prostate cancer.
boolean
C0444669 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0600139 (UMLS CUI [1,4])
Gleason Grading System
Item
5. no dominant gleason 4 component. (e.g.; 4+x is not allowed, but x+4 is eligible)
boolean
C0332326 (UMLS CUI [1])
Gleason Grading System | Primary Gleason pattern | Secondary Gleason pattern | Tertiary Gleason pattern
Item
6. no gleason 5 component (primary, secondary or tertiary).
boolean
C0332326 (UMLS CUI [1])
C1273604 (UMLS CUI [2])
C1273605 (UMLS CUI [3])
C1273608 (UMLS CUI [4])
Core Prostate biopsy Contralateral Positive | Core Involvement Length | Gleason pattern Number Absent
Item
7. subjects may have contralateral positive prostate biopsy in a single core within the eligibility biopsy so long as the involvement of this core is 2mm or less and no gleason 4 or gleason 5 pattern exists. this is considered to be non-dominant (contralateral) tumor burden and is not exclusionary.
boolean
C0444669 (UMLS CUI [1,1])
C0194804 (UMLS CUI [1,2])
C0441988 (UMLS CUI [1,3])
C1514241 (UMLS CUI [1,4])
C0444669 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C1444754 (UMLS CUI [2,3])
C1273606 (UMLS CUI [3,1])
C0237753 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Biopsy Tumor tissue sample failed | Therapeutic procedure Continued
Item
8. in the case that the confirmatory biopsy fails to sample the tumor again, patients will be allowed to continue into the therapeutic phase using the laterality information obtained during the eligibility biopsy.
boolean
C0005558 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical History Risk Preoperative | Comorbidity Risk Preoperative | Medical History Therapeutic procedure Inappropriate | Comorbidity Therapeutic procedure Inappropriate | Protocol Compliance Unwilling | Protocol Compliance Unable
Item
1. medical history or concurrent disease which in the investigators mind places the patient at significant preoperative risk or for which the investigator does not feel this therapy is appropriate. investigator believes subject is unwilling or unable to comply with study protocol requirements.
boolean
C0262926 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0445204 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1548788 (UMLS CUI [3,3])
C0009488 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
C0525058 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
C0525058 (UMLS CUI [6,1])
C1299582 (UMLS CUI [6,2])
Symptom score [AUASI]
Item
2. auasi (american urologic association symptom index) score >/=20
boolean
C4265843 (UMLS CUI [1])
Urinary tract infection
Item
3. active urinary tract infection
boolean
C0042029 (UMLS CUI [1])
Anticoagulant therapy | Antiplatelet therapy | Anticoagulants Discontinue Unsuccessful | Antiplatelet Agents Discontinue Unsuccessful | Biopsy of prostate | Cold Therapy
Item
4. active treatment with anticoagulant/anti-platelet agent that cannot be safely stopped at the time of prostate biopsy and cryotherapy.
boolean
C0150457 (UMLS CUI [1])
C1096021 (UMLS CUI [2])
C0003280 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
C0085826 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C1272705 (UMLS CUI [4,3])
C0194804 (UMLS CUI [5])
C0010412 (UMLS CUI [6])
Medical Castration Initiation Before Biopsy | Male Castration Initiation Before Biopsy | Medical Castration Initiation Post Biopsy | Male Castration Initiation Post Biopsy
Item
5. medical or surgical castration initiated before or after the eligibility biopsy.
boolean
C1513054 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005558 (UMLS CUI [1,4])
C0007347 (UMLS CUI [2,1])
C1704686 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0005558 (UMLS CUI [2,4])
C1513054 (UMLS CUI [3,1])
C1704686 (UMLS CUI [3,2])
C0687676 (UMLS CUI [3,3])
C0005558 (UMLS CUI [3,4])
C0007347 (UMLS CUI [4,1])
C1704686 (UMLS CUI [4,2])
C0687676 (UMLS CUI [4,3])
C0005558 (UMLS CUI [4,4])
Informed Consent Unable
Item
6. patient is unable to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Bone scan Before Cryosurgery | Neoplasm Metastasis Bone scintigraphy
Item
7. patients will undergo base line bone scan prior to cryoablation to evaluate for regions of abnormal uptake before therapeutic intervention. metastatic disease by bone scintigraphy is exclusionary. bone scans performed within 12 months prior to study entry will be used for study base line purposes and will not need to be repeated, unless clinically indicated.
boolean
C0203668 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0010408 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C3889015 (UMLS CUI [2,2])
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