ID

16727

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 FISH

Link

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

Keywords

Versions (1)
  1. 8/2/16 8/2/16 -
Uploaded on

August 2, 2016

DOI

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License

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

English

FISH 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
FISH Results
Description

FISH Results

Specimen received: Blocks:
Description

Specimen

Data type

integer

Specimen received: Slides:
Description

Specimen

Data type

integer

Date received
Description

Date received

Data type

date

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

Specimen Number

Data type

integer

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0237753
Technician
Description

Technician

Data type

text

Alias
UMLS CUI [1]
C1556020
Number of EGFr Gene copies or Amplification: Check the box that applies.
Description

All samples WILL fall into one of the following 6 categories (Number of EGFr Gene copies or Amplification).

Data type

integer

Alias
UMLS CUI [1]
C1512116
RESULT: Ratio
Description

FISH Result

Data type

text

Alias
UMLS CUI [1,1]
C0162789
UMLS CUI [1,2]
C1274040
RESULT
Description

FISH Result

Data type

integer

Alias
UMLS CUI [1,1]
C0162789
UMLS CUI [1,2]
C1274040
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

text

Alias
UMLS CUI [1]
C1302584
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Similar models

FISH 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
FISH Results
Specimen
Item
Specimen received: Blocks:
integer
Specimen
Item
Specimen received: Slides:
integer
Date received
Item
Date received
date
C1514756 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Specimen Number
Item
Number
integer
C0370003 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Technician
Item
Technician
text
C1556020 (UMLS CUI [1])
Item
Number of EGFr Gene copies or Amplification: Check the box that applies.
integer
C1512116 (UMLS CUI [1])
IHC Result
Code List
Number of EGFr Gene copies or Amplification: Check the box that applies.
CL Item
Disomy (≤ 2 copies of EGFr genes in > 90% of cells) (1)
CL Item
Low Trisomy (≤ 2 copies of EGFr genes in ≥ 40% of cells, 3 copies in 10% - 40% of cells, ≥ 4 copies in < 10% of cells) (2)
CL Item
High Trisomy (≤ 2 copies of EGFr genes in ≥ 40% of cells, 3 copies in ≥ 40% of cells, ≥ 4 copies in < 10% of cells) (3)
CL Item
Low Polysomy (≥ 4 copies of EGFr genes in 10% - 40% of cells) (4)
CL Item
High Polysomy (≥ 4 copies of EGFr genes in ≥ 40% of cells) (5)
CL Item
Amplification: a ratio of EGFr gene to chromosome 7of ≥ 2, OR (6)
CL Item
Amplification: 15 copies of EGFr gene per cell > 10% of analyzed tumor cells (7)
FISH Result
Item
RESULT: Ratio
text
C0162789 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
RESULT
integer
C0162789 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
FISH Result
Code List
RESULT
CL Item
Positive (Amplified or High Polysomy) (1)
CL Item
Negative (Not Amplified or Not High Polysomy) (2)
CL Item
Undetermined (3)
Additional Comments
Item
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
text
C1302584 (UMLS CUI [1])
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