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Clinicopathological Features of NSCLC Patients Associated With the Chromosome 2p (EML4-ALK)

CLINICOPATHOLOGICAL FEATURES OF NON-SMALL CELL LUNG CANCER PATIENTS ASSOCIATED WITH THE CHOROMOSOME 2p (EML4-ALK) INVERSION IN MEXICAN POPULATION.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01662635
Acronym
ALK
Enrollment
230
Registered
2012-08-10
Start date
2011-02-28
Completion date
2014-09-30
Last updated
2019-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small-cell Lung Cancer

Keywords

Non-small cell lung cancer., Diagnosis,, Adenocarcinoma,, ALK,, FISH,, IHC, RT-qPCR

Brief summary

Because ALK-positive lung cancer constitutes less than 5% of all lung cancers, it is critically important to select those patients who are more likely to have the ALK mutation. Clinical characteristics of patients with mutations in the target gene should also be known, so that the incidence of a given target mutation is established in a specific population. There is not incidence known in Mexican population, but it is believed it is greater.

Detailed description

Lung adenocarcinoma studies. The only inclusion criterion was the availability of tissue for biomarker studies. To identify ALK rearrangements, fluorescence in situ hybridization (FISH) studies were performed on 3 to 4 mm thick paraffin sections from NSCLCs. The commercially labeled Vysis LSI ALK Dual Color (split-apart), break-apart rearrangement probe (Abbott Molecular, Abbott Park, IL) was used to detect any rearrangement involving the ALK gene. The probe hybridizes to band 2p23, on either side of the ALK gene breakpoint. Criteria for probe signal interpretation in at least 200 interphase nuclei were as follow: 1) separated green and orange signals or single red signals identified cells with rearranged ALK; 2) overlapping of red and green signals (yellowish) indicated cells in which ALK was not rearranged. FISH-positive samples for ALK rearrangement were defined as having cells with a clearly separated pair of probe signals, or with \>15% of cells having loss of the 5´(centromeric) probe. The higher threshold for loss is necessary because parts of probes can be lost during sectioning. The aim of our study is to evaluate the utility of IHC with 5A4 and RT-qPCR in the detection of ALK rearrangements in NSCLC compared with the current method of choice, FISH. Further, we report on the demographics, and clinicopathologic features of ALK-rearranged NSCLC in a Latin-American population. Clinical details of these patients were included in a database. Further results will be analyzed with the program SPSS17

Interventions

None listed

Sponsors

Instituto Nacional de Cancerologia de Mexico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* The only inclusion criterion was the availability of tissue for biomarker studies.

Exclusion criteria

* Disease Progression

Design outcomes

Primary

MeasureTime frameDescription
FISH, IHC, RT-qPCR ComparisonTWO YEARS200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR.

Countries

Mexico

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
Demographics and Clinical Features of Overall Population
The baseline characteristics of our population were on basis of the presence or absence of ALK gene.
200
Total200

Withdrawals & dropouts

PeriodReasonFG000
Overall Studyscarce samples for evaluation30

Baseline characteristics

CharacteristicDemographics and Clinical Features of Overall Population
Age, Customized
55 to 87 years old
109 participants
Age, Customized
< 55 years old
91 participants
ECOG Performance status
ECOG 0-1; ALK -
148 participants
ECOG Performance status
ECOG 0-1; ALK +
15 participants
ECOG Performance status
ECOG 2-3; ALK -
33 participants
ECOG Performance status
ECOG 2-3; ALK +
4 participants
Histology
Non-squamus; ALK -
5 participants
Histology
Non-squamus; ALK +
2 participants
Histology
Squamus; ALK -
176 participants
Histology
Squamus; ALK+
17 participants
Histology Subtype
Acinar; ALK -
39 participants
Histology Subtype
Acinar; ALK +
5 participants
Histology Subtype
Adenousquamous; ALK -
16 participants
Histology Subtype
Adenousquamous; ALK +
0 participants
Histology Subtype
Lepidic; ALK -
14 participants
Histology Subtype
Lepidic; ALK +
3 participants
Histology Subtype
Micropapilar; ALK -
10 participants
Histology Subtype
Micropapilar; ALK +
1 participants
Histology Subtype
No otherwise specified; ALK -
42 participants
Histology Subtype
No otherwise specified; ALK +
5 participants
Histology Subtype
Papilar; ALK -
13 participants
Histology Subtype
Papilar; ALK +
2 participants
Histology Subtype
Solid; ALK -
47 participants
Histology Subtype
Solid; ALK +
3 participants
Sex: Female, Male
Female
113 Participants
Sex: Female, Male
Male
87 Participants
Smoking history
Non smokers ALK +
12 participants
Smoking history
Non smokers ALK-
95 participants
Smoking history
smokers ALK-
86 participants
Smoking history
Smokers ALK+
7 participants
Wood smoke expossure
Absent; ALK -
117 participants
Wood smoke expossure
Absent; ALK +
9 participants
Wood smoke expossure
Present; ALK -
64 participants
Wood smoke expossure
Present; ALK +
10 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

FISH, IHC, RT-qPCR Comparison

200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR.

Time frame: TWO YEARS

Population: The only selection criteria of our subjets was the availability of tumor tissue to perform tests.

ArmMeasureGroupValue (NUMBER)
FISH TestFISH, IHC, RT-qPCR ComparisonALK+18 participants
FISH TestFISH, IHC, RT-qPCR ComparisonALK-182 participants
IHC TestFISH, IHC, RT-qPCR ComparisonALK+15 participants
IHC TestFISH, IHC, RT-qPCR ComparisonALK-48 participants
RT-qPCR TestFISH, IHC, RT-qPCR ComparisonALK+5 participants
RT-qPCR TestFISH, IHC, RT-qPCR ComparisonALK-43 participants
Comparison: Continuous variables were summarized as arithmetic means, medians and standard deviations; and categorical variables were reported as proportions with 95% confidence intervals. Inferential comparisons were performed using Student's t test. The x2 or Fisher's exact tests were used to assess significance among categorical variables.p-value: <0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026