ID

31471

Description

Immune Response Following Treatment of Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence; ODM derived from: https://clinicaltrials.gov/show/NCT01147536

Link

https://clinicaltrials.gov/show/NCT01147536

Keywords

  1. 8/26/18 8/26/18 -
Copyright Holder

Agenus Inc.

Uploaded on

August 26, 2018

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Renal Cell Carcinoma NCT01147536

Eligibility Renal Cell Carcinoma NCT01147536

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmation of histological diagnosis of rcc with evidence of >/= 25% clear cell carcinoma
Description

histological confirmation of renal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0449575
UMLS CUI [1,2]
C0007134
ajcc tnm tumor stage at intermediate risk for recurrence
Description

AJCC tumor staging intermediate risk for recurrence

Data type

boolean

Alias
UMLS CUI [1,1]
C0441915
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C3640764
UMLS CUI [1,4]
C0034897
at least 8 doses of vaccine available from patient's tumor
Description

Availability of cancer vaccines

Data type

boolean

Alias
UMLS CUI [1,1]
C0376659
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C0470187
life expectancy of at least 3 months
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ecog ps of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
cardiovascular disease status of nyha class less than 2
Description

Concomitant cardiovascular diseases, NYHA class

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C1275491
adequate hematopoietic, renal and hepatic function
Description

Adequate hematopoietic, renal and hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0541533
negative serology tests for hiv, htlv-1, hbsag, anti-hcv-ab
Description

negative Infection status of hiv, htlv-1, hbsag, anti-hcv-ab

Data type

boolean

Alias
UMLS CUI [1]
C0481430
UMLS CUI [2,1]
C0020094
UMLS CUI [2,2]
C1513916
UMLS CUI [3]
C0919711
UMLS CUI [4]
C0853904
females must have negative pregnancy test
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of metastatic or residual rcc
Description

Metastatic or residual renal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0278678
UMLS CUI [2,1]
C0007134
UMLS CUI [2,2]
C0543478
documented radiological enlarged lymph nodes
Description

Radiology: Enlargement of lymph nodes

Data type

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C0043299
females who are pregnant or breastfeeding
Description

Pregnancy or breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of any other investigational product from 4 weeks post-surgery
Description

Use of post-operative experimental drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2112579
splenectomy performed during nephrectomy
Description

Splenectomy performed during nephrectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0037995
UMLS CUI [1,2]
C0027695

Similar models

Eligibility Renal Cell Carcinoma NCT01147536

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
histological confirmation of renal cell carcinoma
Item
confirmation of histological diagnosis of rcc with evidence of >/= 25% clear cell carcinoma
boolean
C0449575 (UMLS CUI [1,1])
C0007134 (UMLS CUI [1,2])
AJCC tumor staging intermediate risk for recurrence
Item
ajcc tnm tumor stage at intermediate risk for recurrence
boolean
C0441915 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C3640764 (UMLS CUI [1,3])
C0034897 (UMLS CUI [1,4])
Availability of cancer vaccines
Item
at least 8 doses of vaccine available from patient's tumor
boolean
C0376659 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Life expectancy
Item
life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog ps of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Concomitant cardiovascular diseases, NYHA class
Item
cardiovascular disease status of nyha class less than 2
boolean
C0007222 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Adequate hematopoietic, renal and hepatic function
Item
adequate hematopoietic, renal and hepatic function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0541533 (UMLS CUI [3])
negative Infection status of hiv, htlv-1, hbsag, anti-hcv-ab
Item
negative serology tests for hiv, htlv-1, hbsag, anti-hcv-ab
boolean
C0481430 (UMLS CUI [1])
C0020094 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0919711 (UMLS CUI [3])
C0853904 (UMLS CUI [4])
Pregnancy
Item
females must have negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic or residual renal cell carcinoma
Item
evidence of metastatic or residual rcc
boolean
C0278678 (UMLS CUI [1])
C0007134 (UMLS CUI [2,1])
C0543478 (UMLS CUI [2,2])
Radiology: Enlargement of lymph nodes
Item
documented radiological enlarged lymph nodes
boolean
C0497156 (UMLS CUI [1,1])
C0043299 (UMLS CUI [1,2])
Pregnancy or breast feeding
Item
females who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Use of post-operative experimental drug
Item
use of any other investigational product from 4 weeks post-surgery
boolean
C0304229 (UMLS CUI [1,1])
C2112579 (UMLS CUI [1,2])
Splenectomy performed during nephrectomy
Item
splenectomy performed during nephrectomy
boolean
C0037995 (UMLS CUI [1,1])
C0027695 (UMLS CUI [1,2])

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