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

Uppladdad den

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
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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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