ID

22715

Description

Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01578902

Lien

https://clinicaltrials.gov/show/NCT01578902

Mots-clés

  1. 10/06/2017 10/06/2017 -
Téléchargé le

10 juin 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT01578902

Eligibility Prostate Cancer NCT01578902

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent signed (appendix a)
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
adult men greater than 18 years of age
Description

Gender | Adult | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001675
UMLS CUI [3]
C0001779
histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally reviewed).
Description

Adenocarcinoma of prostate

Type de données

boolean

Alias
UMLS CUI [1]
C0007112
clinical stage t1-t2b, gleason score < 6, and psa < 10 ng/ml
Description

TNM clinical staging | Gleason score | Prostate specific antigen measurement

Type de données

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C3203027
UMLS CUI [3]
C0201544
less than 50% of biopsy cores +ve for cancer
Description

Biopsy Percentage Positive Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1514241
UMLS CUI [1,4]
C0006826
less than 50% overall surface area involved with cancer
Description

Body Surface Area Percentage Involvement with Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005902
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0006826
neoadjuvant hormone suppression therapy is allowed. however, psa, must have been performed within 2 months of starting androgen suppression therapy. if androgen suppression therapy has been started lhrh agonist must be continued for a minimum of 3 months before initiation of gold fiducial marker insertion & radiotherapy planning.
Description

Hormone suppression therapy Neoadjuvant | Prostate specific antigen measurement | Androgen suppression | Luteinizing Hormone-releasing Hormone Agonist | Therapeutic radiology procedure Planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C1535931
UMLS CUI [1,2]
C0600558
UMLS CUI [2]
C0201544
UMLS CUI [3]
C1515985
UMLS CUI [4]
C1518041
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C1301732
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior pelvic radiotherapy.
Description

Radiotherapy to pelvis

Type de données

boolean

Alias
UMLS CUI [1]
C1536155
concurrent anticoagulation medication (if it is unsafe to discontinue for gold seed insertion)
Description

Anticoagulants

Type de données

boolean

Alias
UMLS CUI [1]
C0003280
diagnosis of bleeding diathesis
Description

Bleeding tendency

Type de données

boolean

Alias
UMLS CUI [1]
C1458140
presence of a hip prosthesis
Description

Hip Prosthesis

Type de données

boolean

Alias
UMLS CUI [1]
C0019560
pelvic girth >40cm (to ensure visibility of gold seeds on electronic portal imaging device)
Description

Pelvis Measurement of girth

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030797
UMLS CUI [1,2]
C0203911
large prostate (> 60 cm3) on imaging
Description

Large prostate Imaging

Type de données

boolean

Alias
UMLS CUI [1,1]
C0426732
UMLS CUI [1,2]
C0011923
severe lower urinary tract symptoms (international prostate symptom score > 15 or nocturia > 3)
Description

Lower Urinary Tract Symptoms Severe International prostate symptom score | Nocturia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0574785
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1998280
UMLS CUI [2]
C0028734

Similar models

Eligibility Prostate Cancer NCT01578902

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent signed (appendix a)
boolean
C0021430 (UMLS CUI [1])
Gender | Adult | Age
Item
adult men greater than 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Adenocarcinoma of prostate
Item
histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally reviewed).
boolean
C0007112 (UMLS CUI [1])
TNM clinical staging | Gleason score | Prostate specific antigen measurement
Item
clinical stage t1-t2b, gleason score < 6, and psa < 10 ng/ml
boolean
C3258246 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
Biopsy Percentage Positive Malignant Neoplasms
Item
less than 50% of biopsy cores +ve for cancer
boolean
C0005558 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
Body Surface Area Percentage Involvement with Malignant Neoplasms
Item
less than 50% overall surface area involved with cancer
boolean
C0005902 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
Hormone suppression therapy Neoadjuvant | Prostate specific antigen measurement | Androgen suppression | Luteinizing Hormone-releasing Hormone Agonist | Therapeutic radiology procedure Planned
Item
neoadjuvant hormone suppression therapy is allowed. however, psa, must have been performed within 2 months of starting androgen suppression therapy. if androgen suppression therapy has been started lhrh agonist must be continued for a minimum of 3 months before initiation of gold fiducial marker insertion & radiotherapy planning.
boolean
C1535931 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2])
C1515985 (UMLS CUI [3])
C1518041 (UMLS CUI [4])
C1522449 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to pelvis
Item
prior pelvic radiotherapy.
boolean
C1536155 (UMLS CUI [1])
Anticoagulants
Item
concurrent anticoagulation medication (if it is unsafe to discontinue for gold seed insertion)
boolean
C0003280 (UMLS CUI [1])
Bleeding tendency
Item
diagnosis of bleeding diathesis
boolean
C1458140 (UMLS CUI [1])
Hip Prosthesis
Item
presence of a hip prosthesis
boolean
C0019560 (UMLS CUI [1])
Pelvis Measurement of girth
Item
pelvic girth >40cm (to ensure visibility of gold seeds on electronic portal imaging device)
boolean
C0030797 (UMLS CUI [1,1])
C0203911 (UMLS CUI [1,2])
Large prostate Imaging
Item
large prostate (> 60 cm3) on imaging
boolean
C0426732 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
Lower Urinary Tract Symptoms Severe International prostate symptom score | Nocturia
Item
severe lower urinary tract symptoms (international prostate symptom score > 15 or nocturia > 3)
boolean
C0574785 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1998280 (UMLS CUI [1,3])
C0028734 (UMLS CUI [2])

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