ID

18934

Beschreibung

Magnetic Resonance Imaging to Locate and Characterize Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00082147

Link

https://clinicaltrials.gov/show/NCT00082147

Stichworte

Versionen (1)
  1. 25.11.16 25.11.16 -
Hochgeladen am

25. November 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00082147

Englisch

Eligibility Prostate Cancer NCT00082147

1 Formulare  
Criteria
Beschreibung

Criteria

ecog performance status 0 or 1.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
patients with a trus-guided biopsy for suspected prostate cancer in the past twelve months, or patients with pathologically confirmed adenocarcinoma of the prostate gland and who have not received definitive local therapy.
Beschreibung

Suspected prostate cancer Biopsy TRUS | Adenocarcinoma of prostate Local Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277615
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C2960324
UMLS CUI [2,1]
C0007112
UMLS CUI [2,2]
C1517925
age greater than or equal to 18 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
informed consent: all patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindication to trans-rectal biopsy:
Beschreibung

Medical contraindication Transrectal biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0401641
bleeding disorder;
Beschreibung

Blood Coagulation Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
pt/ptt greater than or equal to 1.5 times the upper limit of normal;
Beschreibung

Prothrombin time | Partial Thromboplastin Time measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0030605
platelets less than or equal to 50k;
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
active anticoagulation;
Beschreibung

anticoagulation

Datentyp

boolean

Alias
UMLS CUI [1]
C0449867
severe immunocompromise;
Beschreibung

Immunodeficiency Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C0205082
severe hemorrhoids;
Beschreibung

Hemorrhoids Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019112
UMLS CUI [1,2]
C0205082
surgically absent rectum.
Beschreibung

Rectum Absent Surgically

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034896
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0543467
contraindication to mri:
Beschreibung

Medical contraindication Magnetic Resonance Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
patients weighing greater than 136 kgs (weight limit for the scanner tables);
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
allergy to mr contrast agent;
Beschreibung

Magnetic resonance imaging contrast media allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0570564
patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with mri.
Beschreibung

Artificial cardiac pacemaker | Cerebral aneurysm clip | Shrapnel injury | Implant device Electronic | MRI Compatible

Datentyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C3266151
UMLS CUI [3,1]
C0522670
UMLS CUI [3,2]
C3263723
UMLS CUI [4,1]
C0021102
UMLS CUI [4,2]
C0013850
UMLS CUI [5,1]
C0024485
UMLS CUI [5,2]
C1524057
allergy to local anesthetics or quinolone antibiotics.
Beschreibung

Hypersensitivity Local Anesthetics | Hypersensitivity Quinolone Antibiotic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002934
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1882518
patients with a known diagnosis of prostate cancer and a known treatment plan to proceed to prostatectomy if the result of the biopsy would not affect surgical management.
Beschreibung

Prostate carcinoma | Prostatectomy planned | Biopsy Affecting Surgical Management

Datentyp

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2]
C0580730
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1515089
other medical conditions deemed by the pi or associates to make the patient ineligible for protocol procedures.
Beschreibung

Medical condition Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C1299582
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00082147

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
ECOG performance status
Item
ecog performance status 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Suspected prostate cancer Biopsy TRUS | Adenocarcinoma of prostate Local Therapy
Item
patients with a trus-guided biopsy for suspected prostate cancer in the past twelve months, or patients with pathologically confirmed adenocarcinoma of the prostate gland and who have not received definitive local therapy.
boolean
C1277615 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C2960324 (UMLS CUI [1,3])
C0007112 (UMLS CUI [2,1])
C1517925 (UMLS CUI [2,2])
Age
Item
age greater than or equal to 18 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
informed consent: all patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Transrectal biopsy
Item
contraindication to trans-rectal biopsy:
boolean
C1301624 (UMLS CUI [1,1])
C0401641 (UMLS CUI [1,2])
Blood Coagulation Disorders
Item
bleeding disorder;
boolean
C0005779 (UMLS CUI [1])
Prothrombin time | Partial Thromboplastin Time measurement
Item
pt/ptt greater than or equal to 1.5 times the upper limit of normal;
boolean
C0033707 (UMLS CUI [1])
C0030605 (UMLS CUI [2])
Platelet Count measurement
Item
platelets less than or equal to 50k;
boolean
C0032181 (UMLS CUI [1])
anticoagulation
Item
active anticoagulation;
boolean
C0449867 (UMLS CUI [1])
Immunodeficiency Severe
Item
severe immunocompromise;
boolean
C0021051 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Hemorrhoids Severe
Item
severe hemorrhoids;
boolean
C0019112 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Rectum Absent Surgically
Item
surgically absent rectum.
boolean
C0034896 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Medical contraindication Magnetic Resonance Imaging
Item
contraindication to mri:
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Body Weight
Item
patients weighing greater than 136 kgs (weight limit for the scanner tables);
boolean
C0005910 (UMLS CUI [1])
Magnetic resonance imaging contrast media allergy
Item
allergy to mr contrast agent;
boolean
C0570564 (UMLS CUI [1])
Artificial cardiac pacemaker | Cerebral aneurysm clip | Shrapnel injury | Implant device Electronic | MRI Compatible
Item
patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with mri.
boolean
C0030163 (UMLS CUI [1])
C3266151 (UMLS CUI [2])
C0522670 (UMLS CUI [3,1])
C3263723 (UMLS CUI [3,2])
C0021102 (UMLS CUI [4,1])
C0013850 (UMLS CUI [4,2])
C0024485 (UMLS CUI [5,1])
C1524057 (UMLS CUI [5,2])
Hypersensitivity Local Anesthetics | Hypersensitivity Quinolone Antibiotic
Item
allergy to local anesthetics or quinolone antibiotics.
boolean
C0020517 (UMLS CUI [1,1])
C0002934 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1882518 (UMLS CUI [2,2])
Prostate carcinoma | Prostatectomy planned | Biopsy Affecting Surgical Management
Item
patients with a known diagnosis of prostate cancer and a known treatment plan to proceed to prostatectomy if the result of the biopsy would not affect surgical management.
boolean
C0600139 (UMLS CUI [1])
C0580730 (UMLS CUI [2])
C0005558 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1515089 (UMLS CUI [3,3])
Medical condition Protocol Compliance Unable
Item
other medical conditions deemed by the pi or associates to make the patient ineligible for protocol procedures.
boolean
C3843040 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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