ID

35896

Beschreibung

Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02501759

Link

https://clinicaltrials.gov/show/NCT02501759

Stichworte

Versionen (1)
  1. 02.04.19 02.04.19 -
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See clinicaltrials.gov

Hochgeladen am

2. April 2019

DOI

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Eligibility Health Status Unknown NCT02501759

Englisch

Eligibility Health Status Unknown NCT02501759

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
scheduled trus-guided biopsy because of clinically suspected prostate cancer (abnormal serum prostate-specific antigen [psa] level and/or abnormal digital rectal examination)
Beschreibung

TRUS Biopsy Scheduled | Prostate carcinoma Suspected | Prostate specific antigen abnormal | Digital Rectal Examination Abnormal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0373345
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C0600139
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0580555
UMLS CUI [4,1]
C1384593
UMLS CUI [4,2]
C0205161
no treatment for prostate cancer has been administered or will be administered before trus guided biopsy
Beschreibung

Therapeutic procedure Absent Prostate carcinoma | Status pre- TRUS Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0600139
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0373345
UMLS CUI [2,3]
C0005558
patient willing to undergo scheduled standard of care trus guided biopsy
Beschreibung

Standard of Care TRUS Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0373345
UMLS CUI [1,3]
C0005558
patient willing and able to provide written informed consent, including willingness to undergo both endorectal multiparametric mri and transrectal mri-guided biopsy at oregon health & science university (ohsu)
Beschreibung

Informed Consent | Multiparametric MRI Endorectal | MRI guided biopsy Transrectal

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C3898221
UMLS CUI [2,2]
C0524447
UMLS CUI [3,1]
C0456854
UMLS CUI [3,2]
C0205518
laboratory values and anticoagulation management per consensus guidelines, including:
Beschreibung

Laboratory Results | Anticoagulation Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0003281
international normalized ratio (inr) >= 1.5
Beschreibung

International Normalized Ratio

Datentyp

boolean

Alias
UMLS CUI [1]
C0525032
platelets >= 50,000
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known contraindication to mri (e.g., severe claustrophobia, intracranial aneurysm clips, intraocular metallic foreign body, cardiac pacemaker); an extensive screening questionnaire will be completed by the subject as part of standard ohsu mri safety measures
Beschreibung

Medical contraindication MRI | Claustrophobia Severe | Aneurysm clip Intracranial | Metallic foreign body Intraocular | Artificial cardiac pacemaker | Screening Questionnaire Completion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C0008909
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0179977
UMLS CUI [3,2]
C0524466
UMLS CUI [4,1]
C1720389
UMLS CUI [4,2]
C3282905
UMLS CUI [5]
C0030163
UMLS CUI [6,1]
C1710032
UMLS CUI [6,2]
C0034394
UMLS CUI [6,3]
C0205197
known contraindication to intravenous gadolinium contrast administration (e.g., renal impairment, known allergy); standard institutional policies on gadolinium and renal function will be followed
Beschreibung

Medical contraindication Intravenous administration Gadolinium-based Contrast Agent | Renal Insufficiency | Hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013125
UMLS CUI [1,3]
C3249258
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0020517
contraindication to placement of endorectal mri coil, biopsy device or ultrasound probe (e.g., severe hemorrhoids, anal fissure, recent rectal surgery, or prior abdominoperineal resection)
Beschreibung

Medical contraindication Placement Endorectal MRI Coil | Medical contraindication Placement Biopsy device | Medical contraindication Placement Ultrasound device | Hemorrhoids Severe | Anal Fissure | Rectal surgery | Abdominoperineal resection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0441587
UMLS CUI [1,3]
C3857139
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0441587
UMLS CUI [2,3]
C0492861
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0441587
UMLS CUI [3,3]
C1875843
UMLS CUI [4,1]
C0019112
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0016167
UMLS CUI [6]
C2066000
UMLS CUI [7]
C2004459
previous inclusion in the study (e.g., a patient who has had negative trus and mri-guided biopsies but continues to have a rising psa)
Beschreibung

Study Subject Participation Status | TRUS Negative | MRI guided biopsy Negative | Raised PSA

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0373345
UMLS CUI [2,2]
C1513916
UMLS CUI [3,1]
C0456854
UMLS CUI [3,2]
C1513916
UMLS CUI [4]
C0178415
active urinary tract infection
Beschreibung

Urinary tract infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0042029
member of vulnerable population including prisoners or mentally disabled patients, in accordance with u.s. department of health and human services (dhhs) definitions
Beschreibung

Vulnerable Population | Prisoners | Mental handicap

Datentyp

boolean

Alias
UMLS CUI [1]
C0949366
UMLS CUI [2]
C0033167
UMLS CUI [3]
C1306341
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Ähnliche Modelle

Eligibility Health Status Unknown NCT02501759

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
TRUS Biopsy Scheduled | Prostate carcinoma Suspected | Prostate specific antigen abnormal | Digital Rectal Examination Abnormal
Item
scheduled trus-guided biopsy because of clinically suspected prostate cancer (abnormal serum prostate-specific antigen [psa] level and/or abnormal digital rectal examination)
boolean
C0373345 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0600139 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0580555 (UMLS CUI [3])
C1384593 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
Therapeutic procedure Absent Prostate carcinoma | Status pre- TRUS Biopsy
Item
no treatment for prostate cancer has been administered or will be administered before trus guided biopsy
boolean
C0087111 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C0332152 (UMLS CUI [2,1])
C0373345 (UMLS CUI [2,2])
C0005558 (UMLS CUI [2,3])
Standard of Care TRUS Biopsy
Item
patient willing to undergo scheduled standard of care trus guided biopsy
boolean
C2936643 (UMLS CUI [1,1])
C0373345 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Informed Consent | Multiparametric MRI Endorectal | MRI guided biopsy Transrectal
Item
patient willing and able to provide written informed consent, including willingness to undergo both endorectal multiparametric mri and transrectal mri-guided biopsy at oregon health & science university (ohsu)
boolean
C0021430 (UMLS CUI [1])
C3898221 (UMLS CUI [2,1])
C0524447 (UMLS CUI [2,2])
C0456854 (UMLS CUI [3,1])
C0205518 (UMLS CUI [3,2])
Laboratory Results | Anticoagulation Therapy
Item
laboratory values and anticoagulation management per consensus guidelines, including:
boolean
C1254595 (UMLS CUI [1])
C0003281 (UMLS CUI [2])
International Normalized Ratio
Item
international normalized ratio (inr) >= 1.5
boolean
C0525032 (UMLS CUI [1])
Platelet Count measurement
Item
platelets >= 50,000
boolean
C0032181 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication MRI | Claustrophobia Severe | Aneurysm clip Intracranial | Metallic foreign body Intraocular | Artificial cardiac pacemaker | Screening Questionnaire Completion
Item
known contraindication to mri (e.g., severe claustrophobia, intracranial aneurysm clips, intraocular metallic foreign body, cardiac pacemaker); an extensive screening questionnaire will be completed by the subject as part of standard ohsu mri safety measures
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0008909 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0179977 (UMLS CUI [3,1])
C0524466 (UMLS CUI [3,2])
C1720389 (UMLS CUI [4,1])
C3282905 (UMLS CUI [4,2])
C0030163 (UMLS CUI [5])
C1710032 (UMLS CUI [6,1])
C0034394 (UMLS CUI [6,2])
C0205197 (UMLS CUI [6,3])
Medical contraindication Intravenous administration Gadolinium-based Contrast Agent | Renal Insufficiency | Hypersensitivity
Item
known contraindication to intravenous gadolinium contrast administration (e.g., renal impairment, known allergy); standard institutional policies on gadolinium and renal function will be followed
boolean
C1301624 (UMLS CUI [1,1])
C0013125 (UMLS CUI [1,2])
C3249258 (UMLS CUI [1,3])
C1565489 (UMLS CUI [2])
C0020517 (UMLS CUI [3])
Medical contraindication Placement Endorectal MRI Coil | Medical contraindication Placement Biopsy device | Medical contraindication Placement Ultrasound device | Hemorrhoids Severe | Anal Fissure | Rectal surgery | Abdominoperineal resection
Item
contraindication to placement of endorectal mri coil, biopsy device or ultrasound probe (e.g., severe hemorrhoids, anal fissure, recent rectal surgery, or prior abdominoperineal resection)
boolean
C1301624 (UMLS CUI [1,1])
C0441587 (UMLS CUI [1,2])
C3857139 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0441587 (UMLS CUI [2,2])
C0492861 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0441587 (UMLS CUI [3,2])
C1875843 (UMLS CUI [3,3])
C0019112 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0016167 (UMLS CUI [5])
C2066000 (UMLS CUI [6])
C2004459 (UMLS CUI [7])
Study Subject Participation Status | TRUS Negative | MRI guided biopsy Negative | Raised PSA
Item
previous inclusion in the study (e.g., a patient who has had negative trus and mri-guided biopsies but continues to have a rising psa)
boolean
C2348568 (UMLS CUI [1])
C0373345 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0456854 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0178415 (UMLS CUI [4])
Urinary tract infection
Item
active urinary tract infection
boolean
C0042029 (UMLS CUI [1])
Vulnerable Population | Prisoners | Mental handicap
Item
member of vulnerable population including prisoners or mentally disabled patients, in accordance with u.s. department of health and human services (dhhs) definitions
boolean
C0949366 (UMLS CUI [1])
C0033167 (UMLS CUI [2])
C1306341 (UMLS CUI [3])
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