ID

30563

Descripción

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

Palabras clave

Versiones (1)
  1. 14/6/18 14/6/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

14 de junio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Prostate Cancer With Intermediate Risk NCT01039038

Inglés

Eligibility Prostate Cancer With Intermediate Risk NCT01039038

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Age

Tipo de datos

boolean

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

Life Expectancy

Tipo de datos

boolean

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

Adenocarcinoma of prostate; Localized

Tipo de datos

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
Descripción

Malignant Neoplasms; Intermediate Risk; criteria

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

WHO performance status scale

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

Hormone Therapy; Authorized

Tipo de datos

boolean

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

rectal; Pathology | Ureter; vesical; Pathology

Tipo de datos

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
Descripción

Informed Consent

Tipo de datos

boolean

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

Social security systems; Affiliate

Tipo de datos

boolean

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

Freedom; Deprivation; guardianship

Tipo de datos

boolean

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

Medical contraindication; Anesthesia procedures

Tipo de datos

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
adenocarcinoma not histologically proven
Descripción

Adenocarcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001418
metastases presence
Descripción

Neoplasm Metastasis

Tipo de datos

boolean

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

Anatomic Node; Pathologic

Tipo de datos

boolean

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

Prostate; Excision; Endoscopy (procedure)

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Medical contraindication; Anesthesia procedures

Tipo de datos

boolean

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

Mental disorders; Uncontrolled | Disease; Study Protocol; incompatibility

Tipo de datos

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
Descripción

follow-up; Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Prostate Cancer With Intermediate Risk NCT01039038

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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