ID

41178

Beschreibung

Laser Based Focal Ablation of Low Grade Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01192438

Link

https://clinicaltrials.gov/show/NCT01192438

Stichworte

Versionen (1)
  1. 06.07.20 06.07.20 -
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See clinicaltrials.gov

Hochgeladen am

6. Juli 2020

DOI

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Creative Commons BY-NC 4.0
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Eligibility Low Grade Prostate Cancer NCT01192438

Englisch

Eligibility Low Grade Prostate Cancer NCT01192438

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male, 45 years of age or older
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
diagnosis of prostate adenocarcinoma
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
clinical stage t1c or t2a
Beschreibung

TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C3258246
gleason score of 7 or less
Beschreibung

Gleason score

Datentyp

boolean

Alias
UMLS CUI [1]
C3203027
a minimum of 12 biopsy cores sampled during diagnostic biopsy
Beschreibung

Core needle biopsy Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C1265611
three or fewer biopsy cores with prostate cancer
Beschreibung

Core needle biopsy Quantity Prostate carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0600139
no single biopsy core with greater than 50% of tumor involvement
Beschreibung

Core needle biopsy Neoplasm Involvement Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0439165
a radiographically visible prostate lesion on mri with concordance to biopsy sextant
Beschreibung

Lesion of prostate MRI | Lesion of prostate Sextant biopsy | Concordance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0577255
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C0577255
UMLS CUI [2,2]
C3846092
UMLS CUI [3]
C4553529
a documented karnofsky performance status of at least 70
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
estimated survival of 20 years or greater, as determined by treating physician
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
ability to give informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous surgery, radiation, or androgen deprivation therapy for prostate cancer
Beschreibung

Operative Surgical Procedure Prostate carcinoma | Therapeutic radiology procedure Prostate carcinoma | Antiandrogen therapy Prostate carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C0279492
UMLS CUI [3,2]
C0600139
presence of any condition (e.g., metal implant, shrapnel) not compatible with mri
Beschreibung

Condition Incompatible MRI | Metallic implant | Shrapnel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C4698019
UMLS CUI [1,3]
C0024485
UMLS CUI [2]
C3693688
UMLS CUI [3]
C0522670
history of previous pelvic radiation
Beschreibung

Radiotherapy to pelvis

Datentyp

boolean

Alias
UMLS CUI [1]
C1536155
severe lower urinary tract symptoms as measured by an international prostate symptom score (ipss) of 20 or greater. (see appendix a)
Beschreibung

Lower Urinary Tract Symptoms Severe IPSS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0574785
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1998280
history of other primary non-skin malignancy within previous three years
Beschreibung

Cancer Other | Exception Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
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Ähnliche Modelle

Eligibility Low Grade Prostate Cancer NCT01192438

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
male, 45 years of age or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Adenocarcinoma of prostate
Item
diagnosis of prostate adenocarcinoma
boolean
C0007112 (UMLS CUI [1])
TNM clinical staging
Item
clinical stage t1c or t2a
boolean
C3258246 (UMLS CUI [1])
Gleason score
Item
gleason score of 7 or less
boolean
C3203027 (UMLS CUI [1])
Core needle biopsy Quantity
Item
a minimum of 12 biopsy cores sampled during diagnostic biopsy
boolean
C1318309 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Core needle biopsy Quantity Prostate carcinoma
Item
three or fewer biopsy cores with prostate cancer
boolean
C1318309 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Core needle biopsy Neoplasm Involvement Percentage
Item
no single biopsy core with greater than 50% of tumor involvement
boolean
C1318309 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
Lesion of prostate MRI | Lesion of prostate Sextant biopsy | Concordance
Item
a radiographically visible prostate lesion on mri with concordance to biopsy sextant
boolean
C0577255 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0577255 (UMLS CUI [2,1])
C3846092 (UMLS CUI [2,2])
C4553529 (UMLS CUI [3])
Karnofsky Performance Status
Item
a documented karnofsky performance status of at least 70
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
estimated survival of 20 years or greater, as determined by treating physician
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
ability to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Operative Surgical Procedure Prostate carcinoma | Therapeutic radiology procedure Prostate carcinoma | Antiandrogen therapy Prostate carcinoma
Item
previous surgery, radiation, or androgen deprivation therapy for prostate cancer
boolean
C0543467 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0279492 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
Condition Incompatible MRI | Metallic implant | Shrapnel
Item
presence of any condition (e.g., metal implant, shrapnel) not compatible with mri
boolean
C0348080 (UMLS CUI [1,1])
C4698019 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C3693688 (UMLS CUI [2])
C0522670 (UMLS CUI [3])
Radiotherapy to pelvis
Item
history of previous pelvic radiation
boolean
C1536155 (UMLS CUI [1])
Lower Urinary Tract Symptoms Severe IPSS
Item
severe lower urinary tract symptoms as measured by an international prostate symptom score (ipss) of 20 or greater. (see appendix a)
boolean
C0574785 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1998280 (UMLS CUI [1,3])
Cancer Other | Exception Skin carcinoma
Item
history of other primary non-skin malignancy within previous three years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
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