ID

42799

Description

Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of Study: Results - IHC

Link

https://clinicaltrials.gov/ct2/show/NCT00373425

Keywords

Versions (2)
  1. 8/7/16 8/7/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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IHC Results, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

English

IHC Results, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms  
Header
Description

Header

Patient's Screening Number
Description

Screening number

Data type

integer

Alias
UMLS CUI [1]
C1710477
Specimen ID (from Pathology Report)
Description

Specimen ID

Data type

text

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C0370003
IHC Results
Description

IHC Results

Specimen received: Blocks:
Description

Block Specimen

Data type

integer

Alias
UMLS CUI [1]
C1533157
Specimen received: Slides:
Description

Specimen

Data type

integer

Alias
UMLS CUI [1]
C1705201
Date received
Description

Date received

Data type

date

Alias
UMLS CUI [1,1]
C1514756
UMLS CUI [1,2]
C0011008
Number
Description

Number

Data type

integer

Technician
Description

Technician

Data type

text

Alias
UMLS CUI [1]
C1556020
Result:
Description

IHC Result

Data type

integer

Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C1274040
Assess the total percentage of tumor cells with membrane stained (any intensity) with EGFr. (% of tumor cells)
Description

EGFR membrane staininig in tumor cells

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C1704680
UMLS CUI [1,3]
C0597032
%
Assess the highest intensity of membrane staining in EGFr stained cells.
Description

Intensity of membrane staining

Data type

integer

Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C1704680
UMLS CUI [1,3]
C0597032
UMLS CUI [1,4]
C0522510
Assess the percentage of cells displaying the highest intensity of membrane staining. (% of cells at highest intensity)
Description

Percentage of cells displaying the highest intensity of membrane staining

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C1704680
UMLS CUI [1,3]
C0597032
UMLS CUI [1,4]
C0522510
%
Describe membrane staining as predominantly complete or incomplete.
Description

Membrane staining

Data type

integer

Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C1704680
UMLS CUI [1,3]
C0597032
UMLS CUI [1,4]
C0007603
UMLS CUI [1,5]
C0205197
Assess the percentage of tumor cells showing only cytoplasmic staining. (% of tumor cells with cytoplasmic staining)
Description

Cytoplasmic staining

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C1704680
UMLS CUI [1,3]
C0597032
UMLS CUI [1,4]
C0010834
%
Additional Comments
Description

Additional Comments

Data type

text

Alias
UMLS CUI [1]
C1830770
Pathologist's Signature
Description

Pathologist Signature

Data type

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0334866
Report Date
Description

Report Date

Data type

date

Alias
UMLS CUI [1]
C1302584
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Similar models

IHC Results, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Screening number
Item
Patient's Screening Number
integer
C1710477 (UMLS CUI [1])
Specimen ID
Item
Specimen ID (from Pathology Report)
text
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
Item Group
IHC Results
Block Specimen
Item
Specimen received: Blocks:
integer
C1533157 (UMLS CUI [1])
Specimen
Item
Specimen received: Slides:
integer
C1705201 (UMLS CUI [1])
Date received
Item
Date received
date
C1514756 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Number
Item
Number
integer
Technician
Item
Technician
text
C1556020 (UMLS CUI [1])
Item
Result:
integer
C0021044 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
IHC Result
Code List
Result:
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Undetermined (3)
EGFR membrane staininig in tumor cells
Item
Assess the total percentage of tumor cells with membrane stained (any intensity) with EGFr. (% of tumor cells)
float
C0034802 (UMLS CUI [1,1])
C1704680 (UMLS CUI [1,2])
C0597032 (UMLS CUI [1,3])
Item
Assess the highest intensity of membrane staining in EGFr stained cells.
integer
C0034802 (UMLS CUI [1,1])
C1704680 (UMLS CUI [1,2])
C0597032 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,4])
Intensity of membrane staining
Code List
Assess the highest intensity of membrane staining in EGFr stained cells.
CL Item
0, No Staining (1)
CL Item
1+, Weak Staining (2)
CL Item
2+, Moderate Staining (3)
CL Item
3+, Strong Staining (4)
Percentage of cells displaying the highest intensity of membrane staining
Item
Assess the percentage of cells displaying the highest intensity of membrane staining. (% of cells at highest intensity)
float
C0034802 (UMLS CUI [1,1])
C1704680 (UMLS CUI [1,2])
C0597032 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,4])
Item
Describe membrane staining as predominantly complete or incomplete.
integer
C0034802 (UMLS CUI [1,1])
C1704680 (UMLS CUI [1,2])
C0597032 (UMLS CUI [1,3])
C0007603 (UMLS CUI [1,4])
C0205197 (UMLS CUI [1,5])
Membrane staining
Code List
Describe membrane staining as predominantly complete or incomplete.
CL Item
Complete (1)
CL Item
Incomplete (2)
Cytoplasmic staining
Item
Assess the percentage of tumor cells showing only cytoplasmic staining. (% of tumor cells with cytoplasmic staining)
float
C0034802 (UMLS CUI [1,1])
C1704680 (UMLS CUI [1,2])
C0597032 (UMLS CUI [1,3])
C0010834 (UMLS CUI [1,4])
Additional Comments
Item
Additional Comments
text
C1830770 (UMLS CUI [1])
Pathologist Signature
Item
Pathologist's Signature
text
C1519316 (UMLS CUI [1,1])
C0334866 (UMLS CUI [1,2])
Report Date
Item
Report Date
date
C1302584 (UMLS CUI [1])
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