ID

30563

Description

Feasibility Study of a Dose Increase by a Boost of Curietherapy in Pulse Dose Rate (PDR) Associated With the Extern Radiotherapy in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01039038

Link

https://clinicaltrials.gov/show/NCT01039038

Keywords

Versions (1)
  1. 6/14/18 6/14/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 14, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Prostate Cancer With Intermediate Risk NCT01039038

English

Eligibility Prostate Cancer With Intermediate Risk NCT01039038

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 50 years and ≤ 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy >10 years
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
localized prostatic adenocarcinoma and histologically proven
Description

Adenocarcinoma of prostate; Localized

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0392752
intermediate risk cancer(t2b or psa between 10 and 20 or gleason = 7(3+4) according to amico criteria
Description

Malignant Neoplasms; Intermediate Risk; criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3640764
UMLS CUI [1,3]
C0243161
metastasis or pelvic pathologic ganglion (≥ 10 mm) absence
Description

Neoplasm Metastasis; Absent | Ganglia; Pelvis; Pathologic; Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0017067
UMLS CUI [2,2]
C0030797
UMLS CUI [2,3]
C1521733
UMLS CUI [2,4]
C0332197
oms < 2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
no previous treatment by radiotherapy and/or curietherapy
Description

Therapeutic radiology procedure; Previous; no | Brachytherapy; Previous; no

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C1298908
UMLS CUI [2,1]
C0006098
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C1298908
hormonotherapy authorized before and during the study
Description

Hormone Therapy; Authorized

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1555472
rectal or uretero-vesical pathology
Description

rectal; Pathology | Ureter; vesical; Pathology

Data type

boolean

Alias
UMLS CUI [1,1]
C0205052
UMLS CUI [1,2]
C0030664
UMLS CUI [2,1]
C0041951
UMLS CUI [2,2]
C0205058
UMLS CUI [2,3]
C0030664
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
social security system affiliation
Description

Social security systems; Affiliate

Data type

boolean

Alias
UMLS CUI [1,1]
C2371809
UMLS CUI [1,2]
C1510825
individual deprived of liberty or placed under the authority of a tutor.
Description

Freedom; Deprivation; guardianship

Data type

boolean

Alias
UMLS CUI [1,1]
C0016694
UMLS CUI [1,2]
C0871712
UMLS CUI [1,3]
C0870627
no anesthesia contraindication
Description

Medical contraindication; Anesthesia procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0002903
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
adenocarcinoma not histologically proven
Description

Adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0001418
metastases presence
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
pathological nodes presence(≥ 10 mm)
Description

Anatomic Node; Pathologic

Data type

boolean

Alias
UMLS CUI [1,1]
C0746922
UMLS CUI [1,2]
C1521733
prior prostate endoscopic resection
Description

Prostate; Excision; Endoscopy (procedure)

Data type

boolean

Alias
UMLS CUI [1,1]
C0033572
UMLS CUI [1,2]
C0728940
UMLS CUI [1,3]
C0014245
history of other malignancy except for appropriately treated superficial basal cell skin cancer
Description

Malignant Neoplasms | Basal cell carcinoma; Superficial; Therapeutic procedure; Appropriate

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C0205124
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C1548787
medical contraindications to anesthesia
Description

Medical contraindication; Anesthesia procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0002903
patients with uncontrolled psychiatric disease or medical disease incompatible with the protocol
Description

Mental disorders; Uncontrolled | Disease; Study Protocol; incompatibility

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0679426
impossibility to respect the medical follow-up of the protocol for geographical, social or psychic reasons
Description

follow-up; Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C1299582
Back to the top of the page

Similar models

Eligibility Prostate Cancer With Intermediate Risk NCT01039038

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 50 years and ≤ 75 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy >10 years
boolean
C0023671 (UMLS CUI [1])
Adenocarcinoma of prostate; Localized
Item
localized prostatic adenocarcinoma and histologically proven
boolean
C0007112 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
Malignant Neoplasms; Intermediate Risk; criteria
Item
intermediate risk cancer(t2b or psa between 10 and 20 or gleason = 7(3+4) according to amico criteria
boolean
C0006826 (UMLS CUI [1,1])
C3640764 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Neoplasm Metastasis; Absent | Ganglia; Pelvis; Pathologic; Absent
Item
metastasis or pelvic pathologic ganglion (≥ 10 mm) absence
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0017067 (UMLS CUI [2,1])
C0030797 (UMLS CUI [2,2])
C1521733 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
WHO performance status scale
Item
oms < 2
boolean
C1298650 (UMLS CUI [1])
Therapeutic radiology procedure; Previous; no | Brachytherapy; Previous; no
Item
no previous treatment by radiotherapy and/or curietherapy
boolean
C1522449 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C0006098 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1298908 (UMLS CUI [2,3])
Hormone Therapy; Authorized
Item
hormonotherapy authorized before and during the study
boolean
C0279025 (UMLS CUI [1,1])
C1555472 (UMLS CUI [1,2])
rectal; Pathology | Ureter; vesical; Pathology
Item
rectal or uretero-vesical pathology
boolean
C0205052 (UMLS CUI [1,1])
C0030664 (UMLS CUI [1,2])
C0041951 (UMLS CUI [2,1])
C0205058 (UMLS CUI [2,2])
C0030664 (UMLS CUI [2,3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Social security systems; Affiliate
Item
social security system affiliation
boolean
C2371809 (UMLS CUI [1,1])
C1510825 (UMLS CUI [1,2])
Freedom; Deprivation; guardianship
Item
individual deprived of liberty or placed under the authority of a tutor.
boolean
C0016694 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0870627 (UMLS CUI [1,3])
Medical contraindication; Anesthesia procedures
Item
no anesthesia contraindication
boolean
C1301624 (UMLS CUI [1,1])
C0002903 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Adenocarcinoma
Item
adenocarcinoma not histologically proven
boolean
C0001418 (UMLS CUI [1])
Neoplasm Metastasis
Item
metastases presence
boolean
C0027627 (UMLS CUI [1])
Anatomic Node; Pathologic
Item
pathological nodes presence(≥ 10 mm)
boolean
C0746922 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
Prostate; Excision; Endoscopy (procedure)
Item
prior prostate endoscopic resection
boolean
C0033572 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C0014245 (UMLS CUI [1,3])
Malignant Neoplasms | Basal cell carcinoma; Superficial; Therapeutic procedure; Appropriate
Item
history of other malignancy except for appropriately treated superficial basal cell skin cancer
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C0205124 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1548787 (UMLS CUI [2,4])
Medical contraindication; Anesthesia procedures
Item
medical contraindications to anesthesia
boolean
C1301624 (UMLS CUI [1,1])
C0002903 (UMLS CUI [1,2])
Mental disorders; Uncontrolled | Disease; Study Protocol; incompatibility
Item
patients with uncontrolled psychiatric disease or medical disease incompatible with the protocol
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0679426 (UMLS CUI [2,3])
follow-up; Unable
Item
impossibility to respect the medical follow-up of the protocol for geographical, social or psychic reasons
boolean
C1522577 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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