ID

36939

Description

Improving Quality of Life After Prostate Brachytherapy: a Comparison of HDR and LDR Brachytherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01936883

Lien

https://clinicaltrials.gov/show/NCT01936883

Mots-clés

  1. 22/06/2019 22/06/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

22 juin 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Prostate Cancer Upper Tier Intermediate Risk or High Risk NCT01936883

Eligibility Prostate Cancer Upper Tier Intermediate Risk or High Risk NCT01936883

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
upper tier intermediate risk with at least 2 of the following factors
Description

Intermediate Risk Prostate carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C3640764
UMLS CUI [1,2]
C0600139
1. tumor-nodes-metastases tumor stage 2b or greater
Description

Secondary malignant neoplasm of lymph node TNM clinical staging

Type de données

boolean

Alias
UMLS CUI [1,1]
C0686619
UMLS CUI [1,2]
C3258246
2. gleason score 7
Description

Gleason score

Type de données

boolean

Alias
UMLS CUI [1]
C3203027
3. psa > 10
Description

Prostate specific antigen measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201544
4. > 50% of the biopsies positive
Description

Biopsy Percentage Positive

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1514241
or high risk prostate cancer with one of the following factors
Description

High risk Prostate carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0600139
1. t3a
Description

TNM clinical staging

Type de données

boolean

Alias
UMLS CUI [1]
C3258246
2. gleason score8-10
Description

Gleason score

Type de données

boolean

Alias
UMLS CUI [1]
C3203027
3. psa >20
Description

Prostate specific antigen measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201544
positive prostate biopsy within 6 months (reviewed centrally)
Description

Biopsy of prostate Positive

Type de données

boolean

Alias
UMLS CUI [1,1]
C0194804
UMLS CUI [1,2]
C1514241
international prostate symptom score < 16
Description

International Prostate Symptom Score

Type de données

boolean

Alias
UMLS CUI [1]
C1998280
prostate volume < 60 cc
Description

Prostate volume

Type de données

boolean

Alias
UMLS CUI [1]
C1441416
negative staging ct and bone scan within 3 months prior to registration
Description

TNM clinical staging Negative CT | TNM clinical staging Negative Bone scan

Type de données

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C3258246
UMLS CUI [2,2]
C1513916
UMLS CUI [2,3]
C0203668
history and physical examination within 90 days prior to registration
Description

Medical History | Physical Examination

Type de données

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0031809
european cooperative oncology group performance status 0-1 prior to registration
Description

Performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1518965
age >45
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
patient suitable for procedure under anesthesia
Description

Patient Suitable Procedure Anesthesia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0184661
UMLS CUI [1,4]
C0002903
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior invasive malignancy (except non melanoma skin cancer) unless disease-free for at least 3 years prior to registration
Description

Invasive cancer | Exception Skin carcinoma | Exception Disease Free of Duration

Type de données

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
UMLS CUI [3,4]
C0449238
previous prostatectomy, cryotherapy or high intensity focussed ultrasound for prostate cancer
Description

Prostatectomy Prostate carcinoma | Cold Therapy Prostate carcinoma | High intensity focused ultrasound Prostate carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0033573
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0010412
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C0441583
UMLS CUI [3,2]
C0600139
previous pelvic irradiation or prostate brachytherapy
Description

Radiotherapy to pelvis | Brachytherapy to prostate

Type de données

boolean

Alias
UMLS CUI [1]
C1536155
UMLS CUI [2]
C0854662

Similar models

Eligibility Prostate Cancer Upper Tier Intermediate Risk or High Risk NCT01936883

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Intermediate Risk Prostate carcinoma
Item
upper tier intermediate risk with at least 2 of the following factors
boolean
C3640764 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Secondary malignant neoplasm of lymph node TNM clinical staging
Item
1. tumor-nodes-metastases tumor stage 2b or greater
boolean
C0686619 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Gleason score
Item
2. gleason score 7
boolean
C3203027 (UMLS CUI [1])
Prostate specific antigen measurement
Item
3. psa > 10
boolean
C0201544 (UMLS CUI [1])
Biopsy Percentage Positive
Item
4. > 50% of the biopsies positive
boolean
C0005558 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
High risk Prostate carcinoma
Item
or high risk prostate cancer with one of the following factors
boolean
C0332167 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
TNM clinical staging
Item
1. t3a
boolean
C3258246 (UMLS CUI [1])
Gleason score
Item
2. gleason score8-10
boolean
C3203027 (UMLS CUI [1])
Prostate specific antigen measurement
Item
3. psa >20
boolean
C0201544 (UMLS CUI [1])
Biopsy of prostate Positive
Item
positive prostate biopsy within 6 months (reviewed centrally)
boolean
C0194804 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
International Prostate Symptom Score
Item
international prostate symptom score < 16
boolean
C1998280 (UMLS CUI [1])
Prostate volume
Item
prostate volume < 60 cc
boolean
C1441416 (UMLS CUI [1])
TNM clinical staging Negative CT | TNM clinical staging Negative Bone scan
Item
negative staging ct and bone scan within 3 months prior to registration
boolean
C3258246 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C3258246 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0203668 (UMLS CUI [2,3])
Medical History | Physical Examination
Item
history and physical examination within 90 days prior to registration
boolean
C0262926 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
Performance status
Item
european cooperative oncology group performance status 0-1 prior to registration
boolean
C1518965 (UMLS CUI [1])
Age
Item
age >45
boolean
C0001779 (UMLS CUI [1])
Patient Suitable Procedure Anesthesia
Item
patient suitable for procedure under anesthesia
boolean
C0030705 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C0002903 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Invasive cancer | Exception Skin carcinoma | Exception Disease Free of Duration
Item
prior invasive malignancy (except non melanoma skin cancer) unless disease-free for at least 3 years prior to registration
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
Prostatectomy Prostate carcinoma | Cold Therapy Prostate carcinoma | High intensity focused ultrasound Prostate carcinoma
Item
previous prostatectomy, cryotherapy or high intensity focussed ultrasound for prostate cancer
boolean
C0033573 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0010412 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0441583 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
Radiotherapy to pelvis | Brachytherapy to prostate
Item
previous pelvic irradiation or prostate brachytherapy
boolean
C1536155 (UMLS CUI [1])
C0854662 (UMLS CUI [2])

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