NCT02010047

Brief Summary

The anaplastic lymphoma kinase gene(ALK) is mutated approximately 5% of non-small cell lung cancers. Testing for this gene is important because there are drugs known as ALK inhibitors that have been shown to significantly delay the progression of ALK-mutated lung cancers. There are a number of ways to test for the presence of the ALK gene in lung cancer biopsy tissue. One method involves making slides and staining them to detect the ALK protein. This is called immunohistochemistry. Another method called fluorescence in situ hybridization(FISH)is used to detect rearrangements of the ALK gene associated with lung cancer. Although both these tests are widely used to test for ALK gene abnormalities, the techniques may not always find the ALK gene mutation because they are not sensitive enough or not enough cancer cells are present in the lung biopsy. This study is being performed to determine if a technique called quantitation polymerase chain reaction (qPCR) is as accurate or better at finding the ALK gene mutation in lung cancer biopsy tissue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable nonsmall-cell-lung-cancer

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable nonsmall-cell-lung-cancer

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2015

Completed
Last Updated

August 8, 2017

Status Verified

July 1, 2014

Enrollment Period

1.7 years

First QC Date

December 5, 2013

Last Update Submit

August 4, 2017

Conditions

Nonsmall Cell Lung Cancer

Keywords

Anaplastic lymphoma kinase genePolymerase chain reactionImmunohistochemistryFluorescence in situ hybridization

Outcome Measures

Primary Outcomes (1)

  • To determine the true number of ALK positives and negatives of a qPCR assay for the detection in FFPE lung cancer biopsy specimens of ALK status in comparison with IHC and FISH ALK detection technologies.

    Up to 24 weeks after the completing of enrollment of 72 ALK negative and 72 ALK positive tumor blocks

Secondary Outcomes (1)

  • The analysis of plasma and serum collected from those patients with ALK-positive NSCLC to assess the feasibility for the use of non-invasive sampling in the diagnosis and disease monitoring of lung cancer.

    After completion of enrollemnt of 72 ALK postive tumor blocks.

Study Arms (1)

IHC, FISH and qPCR ALK assays

EXPERIMENTAL

ALK testing by IHC and FISH will be compared to ALK qPCR testing on NSCLC FFPE tissue.

Device: ALK qPCR assay

Interventions

ALK qPCR assayDEVICE

72 IHC ALK-negative and 72 IHC ALK-positive FFPE samples will tested with FISH and qPCR to determine the sensitivity and specificity of the ALK qPCR assay.

IHC, FISH and qPCR ALK assays

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • You have a confirmed diagnosis of non-squamous, non-endocrine non-small cell lung cancer.
  • Your cancer biopsy has sufficient cancer cells to be tested for the (Epidermal Growth Factor Receptor (EGFR) mutation, the ALK fusion gene abnormality and the research ALK testing.
  • Your lung cancer biopsy is determined not to have a mutation in the EGFR gene.
  • You are 19 years old or older.
  • You fully understand the study and give informed consent to participate as demonstrated by signing the consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

BC Cancer Agency-Abbotsford Centre

Abbotsford, British Columbia, V2S 0C2, Canada

Location

BC Cancer Agency-Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Lions Gate Hospital

North Vancouver, British Columbia, V7L 2L7, Canada

Location

BC Cancer Agency-Centre for the North

Prince George, British Columbia, V2N 7E9, Canada

Location

BC Cancer Agency, Frase Valley Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

BC Cancer Agency, Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BC Cancer Agency

Victoria, British Columbia, V8R 6V5, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • David L Saltman, MD PhD

    British Columbia Cancer Agency

    PRINCIPAL INVESTIGATOR

  • Aly Karsan, MD

    BC Cancer Agency, Molecular Diagnostic Laboraotry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 12, 2013

Study Start

December 1, 2013

Primary Completion

August 18, 2015

Study Completion

August 18, 2015

Last Updated

August 8, 2017

Record last verified: 2014-07

Locations

CA(7)