ID

21631

Beschreibung

High-Intensity Focused Ultrasound Therapy in Treating Patients With Localized Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00561262

Link

https://clinicaltrials.gov/show/NCT00561262

Stichworte

Versionen (1)
  1. 27.04.17 27.04.17 -
Hochgeladen am

27. April 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00561262

Englisch

Eligibility Prostate Cancer NCT00561262

1 Formulare  
Criteria
Beschreibung

Criteria

histologically confirmed adenocarcinoma of the prostate, meeting the following criteria:
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
gleason score ≤ 7 (patterns 3+4 or 4+3 or less are acceptable)
Beschreibung

Gleason Score

Datentyp

boolean

Alias
UMLS CUI [1]
C0332326
cancer prostate-confined only
Beschreibung

Tumor confined within the prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C1276626
cancer confined to one lobe as defined by transrectal ultrasound (trus) biopsy
Beschreibung

TRUS finding: tumor confined to one lobe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0373345
UMLS CUI [1,2]
C1276487
serum prostate-specific antigen (psa) ≤ 15 ng/ml
Beschreibung

PSA measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201544
prostate volume ≤ 40 cc or ap length of prostate < 4 cm
Beschreibung

Prostate volume and size

Datentyp

boolean

Alias
UMLS CUI [1]
C1441416
UMLS CUI [2]
C1287816
unilateral prostate adenocarcinoma must be verified in stage 1 of this trial unless the patient has had multi-sequence mri and transperineal template biopsies outside of this trial in similar procedure protocols to this trial
Beschreibung

Unilateral prostate adenocarcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0205092
no evidence of metastatic disease
Beschreibung

Metastatic disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
no intraprostatic calcifications ≥ 10 mm in size in cancer-positive side of prostate
Beschreibung

Prostatic calcifications

Datentyp

boolean

Alias
UMLS CUI [1]
C1868729
patient characteristics:
Beschreibung

Patients characterisitics

Datentyp

boolean

Alias
UMLS CUI [1]
C0815172
life expectancy ≥ 5 years
Beschreibung

Life expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
no latex allergies
Beschreibung

Hypersensitivity to latex

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0023115
no american society of anesthesiology surgical risk score iii or iv
Beschreibung

ASA score

Datentyp

boolean

Alias
UMLS CUI [1]
C1531480
no contraindications to mri scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artefact to images)
Beschreibung

Contraindication to MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
must be fit for general anesthesia or regional anesthesia as assessed by the consultant anesthetist
Beschreibung

Health Status: fit for general or regional anesthesia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0002915
UMLS CUI [2,1]
C0018759
UMLS CUI [2,2]
C0002911
prior concurrent therapy:
Beschreibung

Prior concurrent therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0009429
more than 6 months since prior androgen suppression therapy
Beschreibung

Prior antiandrogen therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0205156
no prior radiotherapy for prostate cancer
Beschreibung

Prior radiotherapy for prostate cancer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0600139
no prior chemotherapy for prostate cancer
Beschreibung

Prior chemotherapy for prostate cancer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0600139
no prior significant rectal surgery preventing insertion of transrectal probe
Beschreibung

Prior rectal surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2066000
UMLS CUI [1,2]
C0205156
no prior transurethral resection of the prostate or laser prostatectomy
Beschreibung

Prior transurethral resection or laser prostatectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040771
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0860124
UMLS CUI [2,2]
C0205156
no prior high-intensity focused ultrasound, cryosurgery, thermal, or microwave therapy to the prostate
Beschreibung

Prior high-intensity focused ultrasound, cryosurgery, thermal, or microwave therapy to the prostate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0441583
UMLS CUI [2,1]
C0205156
UMLS CUI [2,2]
C0010408
UMLS CUI [3,1]
C0205156
UMLS CUI [3,2]
C0454527
UMLS CUI [4,1]
C0438673
UMLS CUI [4,2]
C0205156
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00561262

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Adenocarcinoma of prostate
Item
histologically confirmed adenocarcinoma of the prostate, meeting the following criteria:
boolean
C0007112 (UMLS CUI [1])
Gleason Score
Item
gleason score ≤ 7 (patterns 3+4 or 4+3 or less are acceptable)
boolean
C0332326 (UMLS CUI [1])
Tumor confined within the prostate
Item
cancer prostate-confined only
boolean
C1276626 (UMLS CUI [1])
TRUS finding: tumor confined to one lobe
Item
cancer confined to one lobe as defined by transrectal ultrasound (trus) biopsy
boolean
C0373345 (UMLS CUI [1,1])
C1276487 (UMLS CUI [1,2])
PSA measurement
Item
serum prostate-specific antigen (psa) ≤ 15 ng/ml
boolean
C0201544 (UMLS CUI [1])
Prostate volume and size
Item
prostate volume ≤ 40 cc or ap length of prostate < 4 cm
boolean
C1441416 (UMLS CUI [1])
C1287816 (UMLS CUI [2])
Unilateral prostate adenocarcinoma
Item
unilateral prostate adenocarcinoma must be verified in stage 1 of this trial unless the patient has had multi-sequence mri and transperineal template biopsies outside of this trial in similar procedure protocols to this trial
boolean
C0007112 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
Metastatic disease
Item
no evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1])
Prostatic calcifications
Item
no intraprostatic calcifications ≥ 10 mm in size in cancer-positive side of prostate
boolean
C1868729 (UMLS CUI [1])
Patients characterisitics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Life expectancy
Item
life expectancy ≥ 5 years
boolean
C0023671 (UMLS CUI [1])
Hypersensitivity to latex
Item
no latex allergies
boolean
C0020517 (UMLS CUI [1,1])
C0023115 (UMLS CUI [1,2])
ASA score
Item
no american society of anesthesiology surgical risk score iii or iv
boolean
C1531480 (UMLS CUI [1])
Contraindication to MRI
Item
no contraindications to mri scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artefact to images)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Health Status: fit for general or regional anesthesia
Item
must be fit for general anesthesia or regional anesthesia as assessed by the consultant anesthetist
boolean
C0018759 (UMLS CUI [1,1])
C0002915 (UMLS CUI [1,2])
C0018759 (UMLS CUI [2,1])
C0002911 (UMLS CUI [2,2])
Prior concurrent therapy
Item
prior concurrent therapy:
boolean
C0009429 (UMLS CUI [1])
Prior antiandrogen therapy
Item
more than 6 months since prior androgen suppression therapy
boolean
C0279492 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Prior radiotherapy for prostate cancer
Item
no prior radiotherapy for prostate cancer
boolean
C0279134 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Prior chemotherapy for prostate cancer
Item
no prior chemotherapy for prostate cancer
boolean
C1514457 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Prior rectal surgery
Item
no prior significant rectal surgery preventing insertion of transrectal probe
boolean
C2066000 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Prior transurethral resection or laser prostatectomy
Item
no prior transurethral resection of the prostate or laser prostatectomy
boolean
C0040771 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0860124 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Prior high-intensity focused ultrasound, cryosurgery, thermal, or microwave therapy to the prostate
Item
no prior high-intensity focused ultrasound, cryosurgery, thermal, or microwave therapy to the prostate
boolean
C0205156 (UMLS CUI [1,1])
C0441583 (UMLS CUI [1,2])
C0205156 (UMLS CUI [2,1])
C0010408 (UMLS CUI [2,2])
C0205156 (UMLS CUI [3,1])
C0454527 (UMLS CUI [3,2])
C0438673 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
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