ID

36896

Beschrijving

Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02409212

Link

https://clinicaltrials.gov/show/NCT02409212

Trefwoorden

Versies (1)
  1. 19-06-19 19-06-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 juni 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02409212

Engels

Eligibility Prostate Cancer NCT02409212

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
in accordance with nice active surveillance guidelines, men:
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
who have been evaluated using a combination of clinical, bio-chemical, imaging and/or biopsy, within the last 12 months
Beschrijving

Evaluation | Clinical examination | Biochemical finding | Imaging | Biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C1261322
UMLS CUI [2]
C1456356
UMLS CUI [3]
C0428132
UMLS CUI [4]
C0011923
UMLS CUI [5]
C0005558
with histologically confirmed low or intermediate risk prostate cancer, gleason score
Beschrijving

Low Risk Prostate carcinoma Gleason score | Intermediate Risk Prostate carcinoma Gleason score

Datatype

boolean

Alias
UMLS CUI [1,1]
C3538919
UMLS CUI [1,2]
C0600139
UMLS CUI [1,3]
C3203027
UMLS CUI [2,1]
C3640764
UMLS CUI [2,2]
C0600139
UMLS CUI [2,3]
C3203027
≤7 (3+4, not 4+3)
Beschrijving

ID.4

Datatype

boolean

with up to t2a clinical stage tumours
Beschrijving

Neoplasms TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3258246
with pre-treatment psa ≤20 ng/ml
Beschrijving

Prostate specific antigen measurement pre treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C2709094
who are willing to participate in optimal active surveillance and provide written informed consent
Beschrijving

Participation Active surveillance | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0700325
UMLS CUI [2]
C0021430
with life expectancy of ≥10 years
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
men:
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
with unstable angina
Beschrijving

Angina, Unstable

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
with uncontrolled hypertension
Beschrijving

Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
with recent myocardial infarction (within the past 6 months)
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
with pacemakers
Beschrijving

Artificial cardiac pacemaker

Datatype

boolean

Alias
UMLS CUI [1]
C0030163
already undertaking regular physical activity (greater than 90 minutes of moderate intensity exercise, per week) will be excluded
Beschrijving

Regular physical activity | Moderate exercise intensity Duration Weekly

Datatype

boolean

Alias
UMLS CUI [1]
C0815170
UMLS CUI [2,1]
C3841231
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0332174
with any other physical or mental limitation preventing participation in trial assessments
Beschrijving

Physical disability Preventing Participation Assessment | Mental handicap Preventing Participation Assessment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0520817
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0679823
UMLS CUI [1,4]
C1516048
UMLS CUI [2,1]
C1306341
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0679823
UMLS CUI [2,4]
C1516048
participating in other clinical trials which might bias the evaluation of the primary objectives of the present study
Beschrijving

Study Subject Participation Status Biases Evaluation Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0242568
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0008976
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Similar models

Eligibility Prostate Cancer NCT02409212

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
in accordance with nice active surveillance guidelines, men:
boolean
C0079399 (UMLS CUI [1])
Evaluation | Clinical examination | Biochemical finding | Imaging | Biopsy
Item
who have been evaluated using a combination of clinical, bio-chemical, imaging and/or biopsy, within the last 12 months
boolean
C1261322 (UMLS CUI [1])
C1456356 (UMLS CUI [2])
C0428132 (UMLS CUI [3])
C0011923 (UMLS CUI [4])
C0005558 (UMLS CUI [5])
Low Risk Prostate carcinoma Gleason score | Intermediate Risk Prostate carcinoma Gleason score
Item
with histologically confirmed low or intermediate risk prostate cancer, gleason score
boolean
C3538919 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C3203027 (UMLS CUI [1,3])
C3640764 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C3203027 (UMLS CUI [2,3])
ID.4
Item
≤7 (3+4, not 4+3)
boolean
Neoplasms TNM clinical staging
Item
with up to t2a clinical stage tumours
boolean
C0027651 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Prostate specific antigen measurement pre treatment
Item
with pre-treatment psa ≤20 ng/ml
boolean
C0201544 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
Participation Active surveillance | Informed Consent
Item
who are willing to participate in optimal active surveillance and provide written informed consent
boolean
C0679823 (UMLS CUI [1,1])
C0700325 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Life Expectancy
Item
with life expectancy of ≥10 years
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gender
Item
men:
boolean
C0079399 (UMLS CUI [1])
Angina, Unstable
Item
with unstable angina
boolean
C0002965 (UMLS CUI [1])
Uncontrolled hypertension
Item
with uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Myocardial Infarction
Item
with recent myocardial infarction (within the past 6 months)
boolean
C0027051 (UMLS CUI [1])
Artificial cardiac pacemaker
Item
with pacemakers
boolean
C0030163 (UMLS CUI [1])
Regular physical activity | Moderate exercise intensity Duration Weekly
Item
already undertaking regular physical activity (greater than 90 minutes of moderate intensity exercise, per week) will be excluded
boolean
C0815170 (UMLS CUI [1])
C3841231 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
Physical disability Preventing Participation Assessment | Mental handicap Preventing Participation Assessment
Item
with any other physical or mental limitation preventing participation in trial assessments
boolean
C0520817 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
C1306341 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,3])
C1516048 (UMLS CUI [2,4])
Study Subject Participation Status Biases Evaluation Clinical Trial
Item
participating in other clinical trials which might bias the evaluation of the primary objectives of the present study
boolean
C2348568 (UMLS CUI [1,1])
C0242568 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
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