ID

19066

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00172016

Stichworte

Versionen (1)
  1. 02.12.16 02.12.16 -
Hochgeladen am

2. Dezember 2016

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent must be obtained
Beschreibung

Informed Consent

Datentyp

boolean

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

Age

Datentyp

boolean

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

Prostate carcinoma

Datentyp

boolean

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

Secondary malignant neoplasm of bone Evidence of

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

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
Beschreibung

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

Datentyp

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)
Beschreibung

Corrected serum calcium measurement | Serum albumin measurement

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Liver Function Tests | Creatinine measurement, serum

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates

Datentyp

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
Beschreibung

Compliance behavior Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
other protocol-defined inclusion / exclusion criteria apply.
Beschreibung

Clinical Trial Eligibility Criteria Additional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Ähnliche Modelle

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

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