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ID

38449

Beskrivning

Pilot Study of Neo-Adjuvant Everolimus to Treat Advanced Renal Cell Carcinoma - Analysis of Biomarkers; ODM derived from: https://clinicaltrials.gov/show/NCT01107509

Länk

https://clinicaltrials.gov/show/NCT01107509

Nyckelord

Versioner (1)
  1. 2019-10-17 2019-10-17 -
Rättsinnehavare

See clinicaltrials.gov

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17 oktober 2019

DOI

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Creative Commons BY 4.0
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    Eligibility Carcinoma, Renal Cell NCT01107509

    Engelsk

    Eligibility Carcinoma, Renal Cell NCT01107509

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    at least 18 years of age and capable of giving informed consent
    Beskrivning

    Age | Capability Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2,1]
    C2698977
    UMLS CUI [2,2]
    C0021430
    radiological evidence of rcc consisting of: ct scan with stage t2, t3, t3a, t3b, t4, or any stage t with n1/ 2 and/ or metastatic disease
    Beskrivning

    Renal Cell Carcinoma CT scan TNM clinical staging | Neoplasm Metastasis

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0007134
    UMLS CUI [1,2]
    C0040405
    UMLS CUI [1,3]
    C3258246
    UMLS CUI [2]
    C0027627
    having a nephrectomy and willing to have a kidney biopsy
    Beskrivning

    Nephrectomy | Kidney biopsy Willing

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0027695
    UMLS CUI [2,1]
    C0194073
    UMLS CUI [2,2]
    C0600109
    ecog score 0 or 1
    Beskrivning

    ECOG performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    clear cell histology
    Beskrivning

    Clear cell Histology

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0229473
    UMLS CUI [1,2]
    C0344441
    negative for hiv, hepatitis b, and hepatitis c
    Beskrivning

    HIV negative | Hepatitis B test negative | Hepatitis C test negative

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0481430
    UMLS CUI [2]
    C1611173
    UMLS CUI [3]
    C1619717
    negative pregnancy test for women of child-bearing potential
    Beskrivning

    Childbearing Potential Pregnancy test negative

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0427780
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    stage t1 disease without metastases
    Beskrivning

    Disease TNM clinical staging | Neoplasm Metastasis Absent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C3258246
    UMLS CUI [2,1]
    C0027627
    UMLS CUI [2,2]
    C0332197
    abnormal laboratory values at screening within the following ranges:
    Beskrivning

    Laboratory test result abnormal

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0438215
    absolute neutrophil count ≤ 1.5 × 109/ l; platelet count ≤ 100 × 109/ l
    Beskrivning

    Absolute neutrophil count | Platelet Count measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    UMLS CUI [2]
    C0032181
    leukocyte count ≤ 3 × 109/ l; hemoglobin ≤ 80 g/ l; serum creatinine ≥ 2.0 × the upper normal limit (unl); total bilirubin ≤ 1.5 × unl; ast and alt ≤ 3.0 × unl
    Beskrivning

    White Blood Cell Count procedure | Hemoglobin measurement | Serum creatinine raised | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    UMLS CUI [2]
    C0518015
    UMLS CUI [3]
    C0700225
    UMLS CUI [4]
    C1278039
    UMLS CUI [5]
    C0201899
    UMLS CUI [6]
    C0201836
    fasting serum cholesterol ≤ 9.0 mmol/ l; fasting serum triglycerides ≥ 5.0 mmol/l
    Beskrivning

    Fasting cholesterol level | Serum fasting triglyceride measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1282513
    UMLS CUI [2]
    C0582824
    any major illness that, based on the investigator's judgment, will substantially increase the risk associated with a subject's participation in this study
    Beskrivning

    Illness Major Study Subject Participation Status At risk

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0205164
    UMLS CUI [1,3]
    C2348568
    UMLS CUI [1,4]
    C1444641
    other currently active malignancies
    Beskrivning

    Cancer Other

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1707251
    currently taking any medications known to interfere with the metabolism of everolimus
    Beskrivning

    Pharmaceutical Preparations Interfere with Metabolism Everolimus

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C0025519
    UMLS CUI [1,4]
    C0541315
    receiving anticoagulation with warfarin
    Beskrivning

    Anticoagulation Therapy | Warfarin

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0003281
    UMLS CUI [2]
    C0043031
    a history of pulmonary hypertension or interstitial lung disease
    Beskrivning

    Pulmonary Hypertension | Lung Disease, Interstitial

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020542
    UMLS CUI [2]
    C0206062
    Tillbaka till toppen

    Similar models

    Eligibility Carcinoma, Renal Cell NCT01107509

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age | Capability Informed Consent
    Item
    at least 18 years of age and capable of giving informed consent
    boolean
    C0001779 (UMLS CUI [1])
    C2698977 (UMLS CUI [2,1])
    C0021430 (UMLS CUI [2,2])
    Renal Cell Carcinoma CT scan TNM clinical staging | Neoplasm Metastasis
    Item
    radiological evidence of rcc consisting of: ct scan with stage t2, t3, t3a, t3b, t4, or any stage t with n1/ 2 and/ or metastatic disease
    boolean
    C0007134 (UMLS CUI [1,1])
    C0040405 (UMLS CUI [1,2])
    C3258246 (UMLS CUI [1,3])
    C0027627 (UMLS CUI [2])
    Nephrectomy | Kidney biopsy Willing
    Item
    having a nephrectomy and willing to have a kidney biopsy
    boolean
    C0027695 (UMLS CUI [1])
    C0194073 (UMLS CUI [2,1])
    C0600109 (UMLS CUI [2,2])
    ECOG performance status
    Item
    ecog score 0 or 1
    boolean
    C1520224 (UMLS CUI [1])
    Clear cell Histology
    Item
    clear cell histology
    boolean
    C0229473 (UMLS CUI [1,1])
    C0344441 (UMLS CUI [1,2])
    HIV negative | Hepatitis B test negative | Hepatitis C test negative
    Item
    negative for hiv, hepatitis b, and hepatitis c
    boolean
    C0481430 (UMLS CUI [1])
    C1611173 (UMLS CUI [2])
    C1619717 (UMLS CUI [3])
    Childbearing Potential Pregnancy test negative
    Item
    negative pregnancy test for women of child-bearing potential
    boolean
    C3831118 (UMLS CUI [1,1])
    C0427780 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Disease TNM clinical staging | Neoplasm Metastasis Absent
    Item
    stage t1 disease without metastases
    boolean
    C0012634 (UMLS CUI [1,1])
    C3258246 (UMLS CUI [1,2])
    C0027627 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    Laboratory test result abnormal
    Item
    abnormal laboratory values at screening within the following ranges:
    boolean
    C0438215 (UMLS CUI [1])
    Absolute neutrophil count | Platelet Count measurement
    Item
    absolute neutrophil count ≤ 1.5 × 109/ l; platelet count ≤ 100 × 109/ l
    boolean
    C0948762 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    White Blood Cell Count procedure | Hemoglobin measurement | Serum creatinine raised | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
    Item
    leukocyte count ≤ 3 × 109/ l; hemoglobin ≤ 80 g/ l; serum creatinine ≥ 2.0 × the upper normal limit (unl); total bilirubin ≤ 1.5 × unl; ast and alt ≤ 3.0 × unl
    boolean
    C0023508 (UMLS CUI [1])
    C0518015 (UMLS CUI [2])
    C0700225 (UMLS CUI [3])
    C1278039 (UMLS CUI [4])
    C0201899 (UMLS CUI [5])
    C0201836 (UMLS CUI [6])
    Fasting cholesterol level | Serum fasting triglyceride measurement
    Item
    fasting serum cholesterol ≤ 9.0 mmol/ l; fasting serum triglycerides ≥ 5.0 mmol/l
    boolean
    C1282513 (UMLS CUI [1])
    C0582824 (UMLS CUI [2])
    Illness Major Study Subject Participation Status At risk
    Item
    any major illness that, based on the investigator's judgment, will substantially increase the risk associated with a subject's participation in this study
    boolean
    C0221423 (UMLS CUI [1,1])
    C0205164 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    C1444641 (UMLS CUI [1,4])
    Cancer Other
    Item
    other currently active malignancies
    boolean
    C1707251 (UMLS CUI [1])
    Pharmaceutical Preparations Interfere with Metabolism Everolimus
    Item
    currently taking any medications known to interfere with the metabolism of everolimus
    boolean
    C0013227 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0025519 (UMLS CUI [1,3])
    C0541315 (UMLS CUI [1,4])
    Anticoagulation Therapy | Warfarin
    Item
    receiving anticoagulation with warfarin
    boolean
    C0003281 (UMLS CUI [1])
    C0043031 (UMLS CUI [2])
    Pulmonary Hypertension | Lung Disease, Interstitial
    Item
    a history of pulmonary hypertension or interstitial lung disease
    boolean
    C0020542 (UMLS CUI [1])
    C0206062 (UMLS CUI [2])
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