ID

31537

Beschreibung

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

Stichworte

Versionen (1)
  1. 03.09.18 03.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. September 2018

DOI

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Eligibility Prostate Cancer NCT00427999

Englisch

Eligibility Prostate Cancer NCT00427999

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

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

Datentyp

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.
Beschreibung

Serum Prostate Specific Antigen Increased Measurement Quantity

Datentyp

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
Beschreibung

Prostate specific antigen measurement

Datentyp

boolean

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

Age

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Hormone Therapy Change

Datentyp

boolean

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

Prior Chemotherapy

Datentyp

boolean

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

imatinib | Tyrosine kinase inhibitor

Datentyp

boolean

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

Second Cancer

Datentyp

boolean

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

Warfarin Required

Datentyp

boolean

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

HIV Infection | Hepatitis B | Hepatitis C

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

Operative Surgical Procedures Recently

Datentyp

boolean

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

Strontium Isotopes | rhenium

Datentyp

boolean

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

Therapeutic radiology procedure Bone Marrow Percentage

Datentyp

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.
Beschreibung

Experimental drug

Datentyp

boolean

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

Eligibility Criteria Study Protocol

Datentyp

boolean

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

Eligibility Prostate Cancer NCT00427999

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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