ID

18998

Beskrivning

Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy; ODM derived from: https://clinicaltrials.gov/show/NCT00237146

Länk

https://clinicaltrials.gov/show/NCT00237146

Nyckelord

Versioner (1)
  1. 2016-11-29 2016-11-29 -
Uppladdad den

29 november 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00237146

Engelsk

Eligibility Prostate Cancer NCT00237146

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed adenocarcinoma of the prostate.
Beskrivning

Adenocarcinoma of prostate

Datatyp

boolean

Alias
UMLS CUI [1]
C0007112
orchidectomy within the four previous weeks to enter the study.
Beskrivning

Orchiectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0029189
bone metastasis evidenced by bone scan.
Beskrivning

Secondary malignant neoplasm of bone Scan of bone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C0203668
a hip dexa study with a ds < 3.
Beskrivning

Hip DEXA scan

Datatyp

boolean

Alias
UMLS CUI [1]
C1272029
no hormonal therapy previous to enter the study.
Beskrivning

Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0279025
ecog performance score of 0-2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
signed written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
abnormal renal function evidenced by a creatinine clearance ≤60 ml/min.
Beskrivning

Abnormal renal function | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C0373595
any kind of hormonal therapy for prostate cancer previous to enter the study.
Beskrivning

Hormone Therapy Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600139
serum calcium corrected for albumin level < 8.0 mg/dl.
Beskrivning

Corrected serum calcium measurement | Serum albumin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0455288
UMLS CUI [2]
C0523465
wbc < 3.0x10^3, anc < 1500/mm3, hemoglobin < 8.0 g/dl, platelets < 75 x 10^3/l.
Beskrivning

White Blood Cell Count procedure | Absolute neutrophil count | Hemoglobin | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0019046
UMLS CUI [4]
C0032181
abnormal hepatic function evidenced by alt and ast value >2.5 unl
Beskrivning

Liver Dysfunction | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
subjects with any other malignant disease that can affect the bone.
Beskrivning

Malignant Neoplasm Affecting Bone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0262950
subjects with any other non malignant disease that can jeopardize the evaluation of the primary objectives of this trial (severe osteoporosis) or that do not aloud perform the trial evaluations.
Beskrivning

Disease Non-Malignant At risk Clinical Trial | Osteoporosis Severe | Disease Non-Malignant Preventing Trial Evaluation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518371
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0008976
UMLS CUI [2,1]
C0029456
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1518371
UMLS CUI [3,3]
C1292733
UMLS CUI [3,4]
C0008976
UMLS CUI [3,5]
C0220825
known hypersensibility to zoledronic acid or other bisphosphonates.
Beskrivning

Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0257685
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0012544
subjects that in the investigator's opinion can not cooperate with the protocol.
Beskrivning

Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
other protocol inclusion/exclusion criteria may apply.
Beskrivning

Clinical Trial Eligibility Criteria Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Prostate Cancer NCT00237146

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥18
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
histologically confirmed adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
Orchiectomy
Item
orchidectomy within the four previous weeks to enter the study.
boolean
C0029189 (UMLS CUI [1])
Secondary malignant neoplasm of bone Scan of bone
Item
bone metastasis evidenced by bone scan.
boolean
C0153690 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
Hip DEXA scan
Item
a hip dexa study with a ds < 3.
boolean
C1272029 (UMLS CUI [1])
Hormone Therapy
Item
no hormonal therapy previous to enter the study.
boolean
C0279025 (UMLS CUI [1])
ECOG performance status
Item
ecog performance score of 0-2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Abnormal renal function | Creatinine clearance measurement
Item
abnormal renal function evidenced by a creatinine clearance ≤60 ml/min.
boolean
C0151746 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Hormone Therapy Prostate carcinoma
Item
any kind of hormonal therapy for prostate cancer previous to enter the study.
boolean
C0279025 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Corrected serum calcium measurement | Serum albumin measurement
Item
serum calcium corrected for albumin level < 8.0 mg/dl.
boolean
C0455288 (UMLS CUI [1])
C0523465 (UMLS CUI [2])
White Blood Cell Count procedure | Absolute neutrophil count | Hemoglobin | Platelet Count measurement
Item
wbc < 3.0x10^3, anc < 1500/mm3, hemoglobin < 8.0 g/dl, platelets < 75 x 10^3/l.
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Liver Dysfunction | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
abnormal hepatic function evidenced by alt and ast value >2.5 unl
boolean
C0086565 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Malignant Neoplasm Affecting Bone
Item
subjects with any other malignant disease that can affect the bone.
boolean
C0006826 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0262950 (UMLS CUI [1,3])
Disease Non-Malignant At risk Clinical Trial | Osteoporosis Severe | Disease Non-Malignant Preventing Trial Evaluation
Item
subjects with any other non malignant disease that can jeopardize the evaluation of the primary objectives of this trial (severe osteoporosis) or that do not aloud perform the trial evaluations.
boolean
C0012634 (UMLS CUI [1,1])
C1518371 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0029456 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C1518371 (UMLS CUI [3,2])
C1292733 (UMLS CUI [3,3])
C0008976 (UMLS CUI [3,4])
C0220825 (UMLS CUI [3,5])
Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates
Item
known hypersensibility to zoledronic acid or other bisphosphonates.
boolean
C0020517 (UMLS CUI [1,1])
C0257685 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0012544 (UMLS CUI [2,2])
Protocol Compliance Unable
Item
subjects that in the investigator's opinion can not cooperate with the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Clinical Trial Eligibility Criteria Additional
Item
other protocol inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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