ID

31537

Beschrijving

Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00427999

Link

https://clinicaltrials.gov/show/NCT00427999

Trefwoorden

  1. 03-09-18 03-09-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

3 september 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00427999

Eligibility Prostate Cancer NCT00427999

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed prostate carcinoma, which has proven progression after primary hormone therapy (surgical or medicinal castration).
Beschrijving

Prostate carcinoma | Disease Progression | Status post Hormone Therapy Primary | Male Castration | Medical Castration

Datatype

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0279025
UMLS CUI [3,3]
C0205225
UMLS CUI [4]
C0007347
UMLS CUI [5]
C1513054
patients must have increasing psa levels (within 3 months prior to enrollment) with at least two consecutively increasing psa levels.
Beschrijving

Serum Prostate Specific Antigen Increased Measurement Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1883014
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C1265611
psa value before inclusion must be at least 5 ng/ml
Beschrijving

Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
at least 18 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
at least capable of self care and up of at least 50% of waking hours (ecog performance status 0 - 2), adequate bone marrow function and lab results.
Beschrijving

Able to perform self care | Waking Hour Percentage | ECOG performance status | Bone Marrow function | Laboratory Results

Datatype

boolean

Alias
UMLS CUI [1]
C2712073
UMLS CUI [2,1]
C0442696
UMLS CUI [2,2]
C0439227
UMLS CUI [2,3]
C0439165
UMLS CUI [3]
C1520224
UMLS CUI [4,1]
C0005953
UMLS CUI [4,2]
C0031843
UMLS CUI [5]
C1254595
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
change of hormone therapy within 6 weeks prior inclusion
Beschrijving

Hormone Therapy Change

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0392747
prior chemotherapy
Beschrijving

Prior Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
therapy with imatinib, or therapy with other inhibitors of tyrosinkinase.
Beschrijving

imatinib | Tyrosine kinase inhibitor

Datatype

boolean

Alias
UMLS CUI [1]
C0935989
UMLS CUI [2]
C1268567
second neoplasm diagnosed within 5 years before study start.
Beschrijving

Second Cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0751623
patients who require therapy with warfarin
Beschrijving

Warfarin Required

Datatype

boolean

Alias
UMLS CUI [1,1]
C0043031
UMLS CUI [1,2]
C1514873
known diagnosis of hiv, hepatitis b, or hepatitis c infection.
Beschrijving

HIV Infection | Hepatitis B | Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
severe, unstable, or uncontrolled medical disease which would confound diagnoses or evaluations required by the protocol, including severe cardiac insufficiency
Beschrijving

Disease Severe Interferes with Diagnosis | Disease Unstable Interferes with Diagnosis | Disease Uncontrolled Interferes with Diagnosis | Disease Severe Interferes with Evaluation | Disease Unstable Interferes with Evaluation | Disease Uncontrolled Interferes with Evaluation | Heart failure Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0011900
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0011900
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0011900
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C1261322
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0443343
UMLS CUI [5,3]
C0521102
UMLS CUI [5,4]
C1261322
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0205318
UMLS CUI [6,3]
C0521102
UMLS CUI [6,4]
C1261322
UMLS CUI [7,1]
C0018801
UMLS CUI [7,2]
C0205082
surgical therapy within 4 weeks before inclusion.
Beschrijving

Operative Surgical Procedures Recently

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332185
prior therapy with isotopes strontium or rhenium.
Beschrijving

Strontium Isotopes | rhenium

Datatype

boolean

Alias
UMLS CUI [1]
C0038468
UMLS CUI [2]
C0035419
radiation therapy to > 25% of bone marrow within 4 weeks before inclusion.
Beschrijving

Therapeutic radiology procedure Bone Marrow Percentage

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
treatment with other experimental substances within 30 days before study start.
Beschrijving

Experimental drug

Datatype

boolean

Alias
UMLS CUI [1]
C0304229
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Prostate Cancer NCT00427999

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma | Disease Progression | Status post Hormone Therapy Primary | Male Castration | Medical Castration
Item
histologically confirmed prostate carcinoma, which has proven progression after primary hormone therapy (surgical or medicinal castration).
boolean
C0600139 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
C0205225 (UMLS CUI [3,3])
C0007347 (UMLS CUI [4])
C1513054 (UMLS CUI [5])
Serum Prostate Specific Antigen Increased Measurement Quantity
Item
patients must have increasing psa levels (within 3 months prior to enrollment) with at least two consecutively increasing psa levels.
boolean
C1883014 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Prostate specific antigen measurement
Item
psa value before inclusion must be at least 5 ng/ml
boolean
C0201544 (UMLS CUI [1])
Age
Item
at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Able to perform self care | Waking Hour Percentage | ECOG performance status | Bone Marrow function | Laboratory Results
Item
at least capable of self care and up of at least 50% of waking hours (ecog performance status 0 - 2), adequate bone marrow function and lab results.
boolean
C2712073 (UMLS CUI [1])
C0442696 (UMLS CUI [2,1])
C0439227 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C1520224 (UMLS CUI [3])
C0005953 (UMLS CUI [4,1])
C0031843 (UMLS CUI [4,2])
C1254595 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy Change
Item
change of hormone therapy within 6 weeks prior inclusion
boolean
C0279025 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Prior Chemotherapy
Item
prior chemotherapy
boolean
C1514457 (UMLS CUI [1])
imatinib | Tyrosine kinase inhibitor
Item
therapy with imatinib, or therapy with other inhibitors of tyrosinkinase.
boolean
C0935989 (UMLS CUI [1])
C1268567 (UMLS CUI [2])
Second Cancer
Item
second neoplasm diagnosed within 5 years before study start.
boolean
C0751623 (UMLS CUI [1])
Warfarin Required
Item
patients who require therapy with warfarin
boolean
C0043031 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
HIV Infection | Hepatitis B | Hepatitis C
Item
known diagnosis of hiv, hepatitis b, or hepatitis c infection.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Disease Severe Interferes with Diagnosis | Disease Unstable Interferes with Diagnosis | Disease Uncontrolled Interferes with Diagnosis | Disease Severe Interferes with Evaluation | Disease Unstable Interferes with Evaluation | Disease Uncontrolled Interferes with Evaluation | Heart failure Severe
Item
severe, unstable, or uncontrolled medical disease which would confound diagnoses or evaluations required by the protocol, including severe cardiac insufficiency
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0011900 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0011900 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C1261322 (UMLS CUI [4,4])
C0012634 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0521102 (UMLS CUI [5,3])
C1261322 (UMLS CUI [5,4])
C0012634 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C1261322 (UMLS CUI [6,4])
C0018801 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
Operative Surgical Procedures Recently
Item
surgical therapy within 4 weeks before inclusion.
boolean
C0543467 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Strontium Isotopes | rhenium
Item
prior therapy with isotopes strontium or rhenium.
boolean
C0038468 (UMLS CUI [1])
C0035419 (UMLS CUI [2])
Therapeutic radiology procedure Bone Marrow Percentage
Item
radiation therapy to > 25% of bone marrow within 4 weeks before inclusion.
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Experimental drug
Item
treatment with other experimental substances within 30 days before study start.
boolean
C0304229 (UMLS CUI [1])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])

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