ID

38449

Description

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

Lien

https://clinicaltrials.gov/show/NCT01107509

Mots-clés

Versions (1)
  1. 17/10/2019 17/10/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

17 octobre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Carcinoma, Renal Cell NCT01107509

Anglais

Eligibility Carcinoma, Renal Cell NCT01107509

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Age | Capability Informed Consent

Type de données

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
Description

Renal Cell Carcinoma CT scan TNM clinical staging | Neoplasm Metastasis

Type de données

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
Description

Nephrectomy | Kidney biopsy Willing

Type de données

boolean

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

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
clear cell histology
Description

Clear cell Histology

Type de données

boolean

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

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

Type de données

boolean

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

Childbearing Potential Pregnancy test negative

Type de données

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
stage t1 disease without metastases
Description

Disease TNM clinical staging | Neoplasm Metastasis Absent

Type de données

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:
Description

Laboratory test result abnormal

Type de données

boolean

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

Absolute neutrophil count | Platelet Count measurement

Type de données

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
Description

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

Type de données

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
Description

Fasting cholesterol level | Serum fasting triglyceride measurement

Type de données

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
Description

Illness Major Study Subject Participation Status At risk

Type de données

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
Description

Cancer Other

Type de données

boolean

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

Pharmaceutical Preparations Interfere with Metabolism Everolimus

Type de données

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
Description

Anticoagulation Therapy | Warfarin

Type de données

boolean

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

Pulmonary Hypertension | Lung Disease, Interstitial

Type de données

boolean

Alias
UMLS CUI [1]
C0020542
UMLS CUI [2]
C0206062
Retour au début de la page

Similar models

Eligibility Carcinoma, Renal Cell NCT01107509

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial