Trial Outcomes & Findings for Clinicopathological Features of NSCLC Patients Associated With the Chromosome 2p (EML4-ALK) (NCT NCT01662635)
NCT ID: NCT01662635
Last Updated: 2019-01-09
Results Overview
200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR.
Recruitment status
COMPLETED
Target enrollment
230 participants
Primary outcome timeframe
TWO YEARS
Results posted on
2019-01-09
Participant Flow
The recruitment began on February 01, 2011 and finished on September 01, 2014. All samples were obtained at the Instituto Nacional de Cancerología, in Mexico.
Samples were sent to the unit of Anatomic Pathology, where a pathologist confirmed the histologic diagnosis. The only inclusion criterion was the availability of tissue for biomarker studies.
Participant milestones
| Measure |
Determination of ALK by FISH, IHC and RT-qPCR
The only inclusion criterion was the availability of tissue for biomarker studies.
We use a commercially available break-apart probe kit specific to the ALK locus (Vysis LSI ALK Dual Color (split-apart); using the commercially mouse monoclonal ALK antibody for IHC and . Variants 1, 2, 3a, 4 and 5. The qPCR reactions were performed using the TaqMan Universal PCR MasterMix (Applied Biosystems/TaqMan, Life Technologies)
|
|---|---|
|
Overall Study
STARTED
|
230
|
|
Overall Study
COMPLETED
|
200
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Determination of ALK by FISH, IHC and RT-qPCR
The only inclusion criterion was the availability of tissue for biomarker studies.
We use a commercially available break-apart probe kit specific to the ALK locus (Vysis LSI ALK Dual Color (split-apart); using the commercially mouse monoclonal ALK antibody for IHC and . Variants 1, 2, 3a, 4 and 5. The qPCR reactions were performed using the TaqMan Universal PCR MasterMix (Applied Biosystems/TaqMan, Life Technologies)
|
|---|---|
|
Overall Study
scarce samples for evaluation
|
30
|
Baseline Characteristics
Clinicopathological Features of NSCLC Patients Associated With the Chromosome 2p (EML4-ALK)
Baseline characteristics by cohort
| Measure |
Demographics and Clinical Features of Overall Population
n=200 Participants
The baseline characteristics of our population were on basis of the presence or absence of ALK gene.
|
|---|---|
|
Age, Customized
< 55 years old
|
91 participants
n=5 Participants
|
|
Age, Customized
55 to 87 years old
|
109 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
|
Smoking history
Non smokers ALK +
|
12 participants
n=5 Participants
|
|
Smoking history
Smokers ALK+
|
7 participants
n=5 Participants
|
|
Smoking history
Non smokers ALK-
|
95 participants
n=5 Participants
|
|
Smoking history
smokers ALK-
|
86 participants
n=5 Participants
|
|
ECOG Performance status
ECOG 0-1; ALK +
|
15 participants
n=5 Participants
|
|
ECOG Performance status
ECOG 2-3; ALK +
|
4 participants
n=5 Participants
|
|
ECOG Performance status
ECOG 0-1; ALK -
|
148 participants
n=5 Participants
|
|
ECOG Performance status
ECOG 2-3; ALK -
|
33 participants
n=5 Participants
|
|
Histology
Squamus; ALK+
|
17 participants
n=5 Participants
|
|
Histology
Non-squamus; ALK +
|
2 participants
n=5 Participants
|
|
Histology
Squamus; ALK -
|
176 participants
n=5 Participants
|
|
Histology
Non-squamus; ALK -
|
5 participants
n=5 Participants
|
|
Wood smoke expossure
Absent; ALK +
|
9 participants
n=5 Participants
|
|
Wood smoke expossure
Present; ALK +
|
10 participants
n=5 Participants
|
|
Wood smoke expossure
Absent; ALK -
|
117 participants
n=5 Participants
|
|
Wood smoke expossure
Present; ALK -
|
64 participants
n=5 Participants
|
|
Histology Subtype
Lepidic; ALK +
|
3 participants
n=5 Participants
|
|
Histology Subtype
Acinar; ALK +
|
5 participants
n=5 Participants
|
|
Histology Subtype
Papilar; ALK +
|
2 participants
n=5 Participants
|
|
Histology Subtype
Micropapilar; ALK +
|
1 participants
n=5 Participants
|
|
Histology Subtype
Solid; ALK +
|
3 participants
n=5 Participants
|
|
Histology Subtype
Adenousquamous; ALK +
|
0 participants
n=5 Participants
|
|
Histology Subtype
No otherwise specified; ALK +
|
5 participants
n=5 Participants
|
|
Histology Subtype
Lepidic; ALK -
|
14 participants
n=5 Participants
|
|
Histology Subtype
Acinar; ALK -
|
39 participants
n=5 Participants
|
|
Histology Subtype
Papilar; ALK -
|
13 participants
n=5 Participants
|
|
Histology Subtype
Micropapilar; ALK -
|
10 participants
n=5 Participants
|
|
Histology Subtype
Solid; ALK -
|
47 participants
n=5 Participants
|
|
Histology Subtype
Adenousquamous; ALK -
|
16 participants
n=5 Participants
|
|
Histology Subtype
No otherwise specified; ALK -
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: TWO YEARSPopulation: The only selection criteria of our subjets was the availability of tumor tissue to perform tests.
200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR.
Outcome measures
| Measure |
FISH Test
n=200 Participants
We use a commercially available break-apart probe kit specific to the ALK locus (Vysis LSI ALK Dual Color (split-apart); Abbott Molecular, Abbott Park, IL, USA). Slide washing, and counterstaining by DAPI were done following the manufacturer´s protocol (Abbott Molecular, Abbott Park, IL, USA).
|
IHC Test
n=63 Participants
using the commercially mouse monoclonal ALK antibody (dilution 1:25, clone 5A4; Abcam, Cambridge, UK), with OptiView DAB detection Kit (Ventana, Tucson, Arizona, USA). ALK IHC was performed according to the protocols provided by the antibody.
|
RT-qPCR Test
n=48 Participants
The qPCR reactions were performed using the TaqMan Universal PCR MasterMix (Applied Biosystems/TaqMan, Life Technologies) and the following Taqman assays: Hs03654556\_ft (E13;A20), Hs03654557\_ft (E20;A20), Hs03654558\_ft (E6;A20), Hs03654560\_ft (E17;A20), and Hs03654559\_ft (E18;A20). Hs02758991\_ft (GAPDH) assays, whose expression levels are known to be nearly stable among lung tumors
|
|---|---|---|---|
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FISH, IHC, RT-qPCR Comparison
ALK+
|
18 participants
|
15 participants
|
5 participants
|
|
FISH, IHC, RT-qPCR Comparison
ALK-
|
182 participants
|
48 participants
|
43 participants
|
Adverse Events
Adverse Events Not Collected
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Oscar Gerardo Arrieta-Rodríguez
Thoracic Oncology Unit. Instituto Nacional de Cancerología
Phone: +52 55 56280400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place