ID

31572

Beskrivning

Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers; ODM derived from: https://clinicaltrials.gov/show/NCT00676286

Länk

https://clinicaltrials.gov/show/NCT00676286

Nyckelord

Versioner (1)
  1. 2018-09-06 2018-09-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 september 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Prostate Cancer NCT00676286

Engelsk

Eligibility Prostate Cancer NCT00676286

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven adenocarcinoma of the prostate
Beskrivning

Adenocarcinoma of prostate

Datatyp

boolean

Alias
UMLS CUI [1]
C0007112
registration must occur within 16 weeks of last biopsy
Beskrivning

Biopsy Recently

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0332185
history and physical exam (including dre) within 8 weeks prior to registration
Beskrivning

Medical History Recently | Physical Examination Recently | Digital Rectal Examination Recently

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C1384593
UMLS CUI [3,2]
C0332185
patients must have indolent prostate cancer including all of the following: low risk prostate cancer, less or equal to 50 % of core biopsies involved with disease, and less or equal to three biopsies involved with disease
Beskrivning

Prostate carcinoma indolent | Prostate carcinoma Low Risk | Involvement with Disease Core biopsy Percentage | Involvement with Disease Biopsy Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0234227
UMLS CUI [2,1]
C0600139
UMLS CUI [2,2]
C3538919
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C1318309
UMLS CUI [3,4]
C0439165
UMLS CUI [4,1]
C1314939
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0005558
UMLS CUI [4,4]
C1265611
patients must have a minimum of six biopsies (sextant) at registration
Beskrivning

Sextant biopsy Quantity Minimum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3846092
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1524031
psa test within 8 weeks registration
Beskrivning

Prostate specific antigen measurement Recently

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C0332185
creatinine level below 100 umol/l within 8 weeks of registration
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
patients must have no contraindications to mri scans
Beskrivning

Medical contraindication Absent MRI scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0024485
no history of previous malignancies except non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
Beskrivning

Malignant Neoplasms Previous Absent | Exception Skin carcinoma | Exception Cancer Other Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1707251
UMLS CUI [3,3]
C0023671
patients must be reliable for follow up
Beskrivning

Patients Available Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient does not have histologically-proven adenocarcinoma of the prostate
Beskrivning

Adenocarcinoma of prostate Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0332197
last biopsy greater than 16 weeks prior to registration
Beskrivning

Biopsy Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0205156
history and physical exam (including dre) greater that 8 weeks prior to registration
Beskrivning

Medical History Previous | Physical Examination Previous | Digital Rectal Examination Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C1384593
UMLS CUI [3,2]
C0205156
patient does not have indolent disease
Beskrivning

Disease indolent Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0234227
UMLS CUI [1,3]
C0332197
patient has less than six sextant biopsies at registration
Beskrivning

Sextant biopsy Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3846092
UMLS CUI [1,2]
C1265611
psa test done greater than 8 weeks from registration
Beskrivning

Prostate specific antigen measurement Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C0205156
creatinine level greater than 100 umol/l within 8 weeks of registration
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
contraindications to mri scans
Beskrivning

Medical contraindication MRI scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
history of previous malignancies other than non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
Beskrivning

Malignant Neoplasms Previous | Exception Skin carcinoma | Exception Cancer Other Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1707251
UMLS CUI [3,3]
C0023671
patients that are not reliable for follow up
Beskrivning

Patients Unreliable Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C4061925
UMLS CUI [1,3]
C3274571
Tillbaka till toppen

Similar models

Eligibility Prostate Cancer NCT00676286

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically proven adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Biopsy Recently
Item
registration must occur within 16 weeks of last biopsy
boolean
C0005558 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Medical History Recently | Physical Examination Recently | Digital Rectal Examination Recently
Item
history and physical exam (including dre) within 8 weeks prior to registration
boolean
C0262926 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1384593 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
Prostate carcinoma indolent | Prostate carcinoma Low Risk | Involvement with Disease Core biopsy Percentage | Involvement with Disease Biopsy Quantity
Item
patients must have indolent prostate cancer including all of the following: low risk prostate cancer, less or equal to 50 % of core biopsies involved with disease, and less or equal to three biopsies involved with disease
boolean
C0600139 (UMLS CUI [1,1])
C0234227 (UMLS CUI [1,2])
C0600139 (UMLS CUI [2,1])
C3538919 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C1318309 (UMLS CUI [3,3])
C0439165 (UMLS CUI [3,4])
C1314939 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0005558 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
Sextant biopsy Quantity Minimum
Item
patients must have a minimum of six biopsies (sextant) at registration
boolean
C3846092 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
Prostate specific antigen measurement Recently
Item
psa test within 8 weeks registration
boolean
C0201544 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
creatinine level below 100 umol/l within 8 weeks of registration
boolean
C0201976 (UMLS CUI [1])
Medical contraindication Absent MRI scan
Item
patients must have no contraindications to mri scans
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
Malignant Neoplasms Previous Absent | Exception Skin carcinoma | Exception Cancer Other Life Expectancy
Item
no history of previous malignancies except non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1707251 (UMLS CUI [3,2])
C0023671 (UMLS CUI [3,3])
Patients Available Follow-up
Item
patients must be reliable for follow up
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Adenocarcinoma of prostate Absent
Item
patient does not have histologically-proven adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Biopsy Previous
Item
last biopsy greater than 16 weeks prior to registration
boolean
C0005558 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Medical History Previous | Physical Examination Previous | Digital Rectal Examination Previous
Item
history and physical exam (including dre) greater that 8 weeks prior to registration
boolean
C0262926 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1384593 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Disease indolent Absent
Item
patient does not have indolent disease
boolean
C0012634 (UMLS CUI [1,1])
C0234227 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Sextant biopsy Quantity
Item
patient has less than six sextant biopsies at registration
boolean
C3846092 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Prostate specific antigen measurement Previous
Item
psa test done greater than 8 weeks from registration
boolean
C0201544 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
creatinine level greater than 100 umol/l within 8 weeks of registration
boolean
C0201976 (UMLS CUI [1])
Medical contraindication MRI scan
Item
contraindications to mri scans
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Malignant Neoplasms Previous | Exception Skin carcinoma | Exception Cancer Other Life Expectancy
Item
history of previous malignancies other than non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1707251 (UMLS CUI [3,2])
C0023671 (UMLS CUI [3,3])
Patients Unreliable Follow-up
Item
patients that are not reliable for follow up
boolean
C0030705 (UMLS CUI [1,1])
C4061925 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial