ID

19066

Beskrivning

A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates; ODM derived from: https://clinicaltrials.gov/show/NCT00172016

Länk

https://clinicaltrials.gov/show/NCT00172016

Nyckelord

Versioner (1)
  1. 2016-12-02 2016-12-02 -
Uppladdad den

2 december 2016

DOI

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Creative Commons BY 4.0
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Eligibility Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated NCT00172016

Engelsk

Eligibility Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated NCT00172016

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent must be obtained
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
age > 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed diagnosis of carcinoma of the prostate
Beskrivning

Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0600139
current (or previous) objective evidence of metastatic disease to the bone
Beskrivning

Secondary malignant neoplasm of bone Evidence of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C0332120
currently receiving 1st line hormonal therapy with lhrh agonists or other hormonal treatments
Beskrivning

First line treatment Luteinizing Hormone-releasing Hormone Agonist | Hormone Therapy Primary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C1518041
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0205225
ecog performance status of 0, 1, or 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 60 ml/minute or less
Beskrivning

Abnormal renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/l)
Beskrivning

Corrected serum calcium measurement | Serum albumin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0455288
UMLS CUI [2]
C0523465
wbc<3.0x1'000'000'000, anc < 1500/mm3, hgb<8.0 g/dl, platelets < 75 x 1'000'000'000/l.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
liver function tests >2.5 uln, serum creatinine >1.5 uln.
Beskrivning

Liver Function Tests | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0023901
UMLS CUI [2]
C0201976
patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
Beskrivning

Disease Non-Malignant Interferes with Evaluation Primary Endpoint | Disease Non-Malignant Preventing Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518371
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C1261322
UMLS CUI [1,5]
C2986535
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1518371
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0525058
known hypersensitivity 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 who, in the opinion of the investigator, are unlikely to cooperate fully during the study
Beskrivning

Compliance behavior Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
other protocol-defined inclusion / exclusion criteria 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 With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated NCT00172016

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent must be obtained
boolean
C0021430 (UMLS CUI [1])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Prostate carcinoma
Item
histologically confirmed diagnosis of carcinoma of the prostate
boolean
C0600139 (UMLS CUI [1])
Secondary malignant neoplasm of bone Evidence of
Item
current (or previous) objective evidence of metastatic disease to the bone
boolean
C0153690 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
First line treatment Luteinizing Hormone-releasing Hormone Agonist | Hormone Therapy Primary
Item
currently receiving 1st line hormonal therapy with lhrh agonists or other hormonal treatments
boolean
C1708063 (UMLS CUI [1,1])
C1518041 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Abnormal renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 60 ml/minute or less
boolean
C0151746 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Corrected serum calcium measurement | Serum albumin measurement
Item
corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/l)
boolean
C0455288 (UMLS CUI [1])
C0523465 (UMLS CUI [2])
White Blood Cell Count procedure | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
wbc<3.0x1'000'000'000, anc < 1500/mm3, hgb<8.0 g/dl, platelets < 75 x 1'000'000'000/l.
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Liver Function Tests | Creatinine measurement, serum
Item
liver function tests >2.5 uln, serum creatinine >1.5 uln.
boolean
C0023901 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Disease Non-Malignant Interferes with Evaluation Primary Endpoint | Disease Non-Malignant Preventing Protocol Compliance
Item
patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
boolean
C0012634 (UMLS CUI [1,1])
C1518371 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C2986535 (UMLS CUI [1,5])
C0012634 (UMLS CUI [2,1])
C1518371 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates
Item
known hypersensitivity 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])
Compliance behavior Limited
Item
subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Clinical Trial Eligibility Criteria Additional
Item
other protocol-defined inclusion / exclusion criteria apply.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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