ID

18515

Beschreibung

Non-small Cell Lung Cancer Registry; ODM derived from: https://clinicaltrials.gov/show/NCT00099541

Link

https://clinicaltrials.gov/show/NCT00099541

Stichworte

Versionen (1)
  1. 09.11.16 09.11.16 -
Hochgeladen am

9. November 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-Small-Cell Lung Cancer NCT00099541

Englisch

Eligibility Non-Small-Cell Lung Cancer NCT00099541

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age greater than or equal to 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed nsclc (squamous cell carcinoma, adenocarcinoma, large cell carcinoma).
Beschreibung

Non-Small Cell Lung Carcinoma | Squamous cell carcinoma | Adenocarcinoma | Carcinoma, Large Cell

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C0007137
UMLS CUI [3]
C0001418
UMLS CUI [4]
C0206704
unresectable stage iiib with pleural effusion or stage iv nsclc
Beschreibung

Non-Small Cell Lung Carcinoma unresectable | TNM clinical staging | Pleural effusion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1519810
UMLS CUI [2]
C3258246
UMLS CUI [3]
C0032227
ecog performance status of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who received an iv bisphosphonate (e.g.pamidronate; zoledronic acid)
Beschreibung

Intravenous bisphosphonates | pamidronate | zoledronic acid

Datentyp

boolean

Alias
UMLS CUI [1]
C1955566
UMLS CUI [2]
C0043603
UMLS CUI [3]
C0257685
patients who received an oral bisphosphonate therapy in the 6 months prior to screening (alendronate; etidronate; risedronate; tiludronate; ibandronate)
Beschreibung

Diphosphonates Oral | Alendronate | Etidronate | Risedronate | Tiludronate | Ibandronate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0102118
UMLS CUI [3]
C0086268
UMLS CUI [4]
C0246719
UMLS CUI [5]
C0145942
UMLS CUI [6]
C0379199
patients who are currently receiving any investigational drugs that are suspected to have renal toxicity and/or are excreted by the kidneys
Beschreibung

Investigational New Drugs Associated with Toxic nephropathy | Investigational New Drugs Related Kidney Excretion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0595916
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0022646
UMLS CUI [2,4]
C0221102
known clinically significant hypersensitivity to zoledronic acid or other bisphosphonates or any of the excipients in the formulation of zoledronic acid (mannitol, sodium citrate)
Beschreibung

Hypersensitivity Clinical Significance zoledronic acid | Hypersensitivity Clinical Significance Diphosphonates | Hypersensitivity Clinical Significance zoledronic acid Excipient | Hypersensitivity Clinical Significance Mannitol | Hypersensitivity Clinical Significance sodium citrate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0257685
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0012544
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C0257685
UMLS CUI [3,4]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C2826293
UMLS CUI [4,3]
C0024730
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C2826293
UMLS CUI [5,3]
C0142825
abnormal renal function or creatinine clearance
Beschreibung

Abnormal renal function | Creatinine clearance Abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2,1]
C0812399
UMLS CUI [2,2]
C0205161
unstable brain metastasis
Beschreibung

Metastatic malignant neoplasm to brain Unstable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0443343
women of childbearing potential not using a medically recognized form of contraception, as well as women who are breastfeeding
Beschreibung

Childbearing Potential Contraceptive methods Inadequate | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0205412
UMLS CUI [2]
C0006147
patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol
Beschreibung

Condition Non-Malignant Affecting Evaluation Primary Endpoint | Condition Non-Malignant Affecting Therapeutic procedure | Condition Non-Malignant Preventing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1518371
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C1261322
UMLS CUI [1,5]
C2986535
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1518371
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0087111
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1518371
UMLS CUI [3,3]
C1292733
UMLS CUI [3,4]
C0525058
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Ähnliche Modelle

Eligibility Non-Small-Cell Lung Cancer NCT00099541

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age greater than or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma | Squamous cell carcinoma | Adenocarcinoma | Carcinoma, Large Cell
Item
histologically confirmed nsclc (squamous cell carcinoma, adenocarcinoma, large cell carcinoma).
boolean
C0007131 (UMLS CUI [1])
C0007137 (UMLS CUI [2])
C0001418 (UMLS CUI [3])
C0206704 (UMLS CUI [4])
Non-Small Cell Lung Carcinoma unresectable | TNM clinical staging | Pleural effusion
Item
unresectable stage iiib with pleural effusion or stage iv nsclc
boolean
C0007131 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2])
C0032227 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Intravenous bisphosphonates | pamidronate | zoledronic acid
Item
patients who received an iv bisphosphonate (e.g.pamidronate; zoledronic acid)
boolean
C1955566 (UMLS CUI [1])
C0043603 (UMLS CUI [2])
C0257685 (UMLS CUI [3])
Diphosphonates Oral | Alendronate | Etidronate | Risedronate | Tiludronate | Ibandronate
Item
patients who received an oral bisphosphonate therapy in the 6 months prior to screening (alendronate; etidronate; risedronate; tiludronate; ibandronate)
boolean
C0012544 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0102118 (UMLS CUI [2])
C0086268 (UMLS CUI [3])
C0246719 (UMLS CUI [4])
C0145942 (UMLS CUI [5])
C0379199 (UMLS CUI [6])
Investigational New Drugs Associated with Toxic nephropathy | Investigational New Drugs Related Kidney Excretion
Item
patients who are currently receiving any investigational drugs that are suspected to have renal toxicity and/or are excreted by the kidneys
boolean
C0013230 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0595916 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0022646 (UMLS CUI [2,3])
C0221102 (UMLS CUI [2,4])
Hypersensitivity Clinical Significance zoledronic acid | Hypersensitivity Clinical Significance Diphosphonates | Hypersensitivity Clinical Significance zoledronic acid Excipient | Hypersensitivity Clinical Significance Mannitol | Hypersensitivity Clinical Significance sodium citrate
Item
known clinically significant hypersensitivity to zoledronic acid or other bisphosphonates or any of the excipients in the formulation of zoledronic acid (mannitol, sodium citrate)
boolean
C0020517 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0257685 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0012544 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0257685 (UMLS CUI [3,3])
C0015237 (UMLS CUI [3,4])
C0020517 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C0024730 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0142825 (UMLS CUI [5,3])
Abnormal renal function | Creatinine clearance Abnormal
Item
abnormal renal function or creatinine clearance
boolean
C0151746 (UMLS CUI [1])
C0812399 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain Unstable
Item
unstable brain metastasis
boolean
C0220650 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Inadequate | Breast Feeding
Item
women of childbearing potential not using a medically recognized form of contraception, as well as women who are breastfeeding
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0006147 (UMLS CUI [2])
Condition Non-Malignant Affecting Evaluation Primary Endpoint | Condition Non-Malignant Affecting Therapeutic procedure | Condition Non-Malignant Preventing Protocol Compliance
Item
patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol
boolean
C0348080 (UMLS CUI [1,1])
C1518371 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C2986535 (UMLS CUI [1,5])
C0348080 (UMLS CUI [2,1])
C1518371 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C1518371 (UMLS CUI [3,2])
C1292733 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
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