Nonsmall Cell Lung CancerPCRTALKNCT02010047
Comparison of qPCR to IHC and FISH for Detection of ALK Fusion Mutations in FFPE Tissue From NSCLC Patients
A study testing ALK qPCR assay in people with Nonsmall Cell Lung Cancer, run by British Columbia Cancer Agency at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Nonsmall Cell Lung Cancer
- What is being tested?
- ALK qPCR assay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 7 sitesCanada
- Study dates
- Dec 2013to 18 Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
BC Cancer Agency-Abbotsford Centre
Abbotsford British Columbia, British Columbia, V2S 0C2
BC Cancer Agency-Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Lions Gate Hospital
North Vancouver, British Columbia, V7L 2L7
BC Cancer Agency-Centre for the North
Prince George, British Columbia, V2N 7E9
BC Cancer Agency, Frase Valley Centre
Surrey, British Columbia, V3V 1Z2
BC Cancer Agency, Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
BC Cancer Agency
Victoria, British Columbia, V8R 6V5
About this study
Official title: A Study to Compare the Performance of a qPCR-based Assay to Immunohistochemistry (IHC) and Fluorescence in Situ Hybridization (FISH) in the Detection of Anaplastic Lymphoma Kinase (ALK) Fusion Mutations in Formalin Fixed Paraffin-embedded (FFPE) Tissue From Non-small Cell Lung Cancer (NSCLC) Patients.
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.
- Conditions
- Nonsmall Cell Lung Cancer
- Being tested
- ALK qPCR assay
- Keywords
- Anaplastic lymphoma kinase gene, Polymerase chain reaction, Immunohistochemistry, Fluorescence in situ hybridization
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| IHC, FISH and qPCR ALK assays | Experimental | ALK testing by IHC and FISH will be compared to ALK qPCR testing on NSCLC FFPE tissue. Receives: Device: ALK qPCR assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After completion of enrollemnt of 72 ALK postive tumor blocks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion18 Aug 2015
- Study completion18 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Insight Genetics
- Responsible party
- Sponsor
- Investigators
- David L Saltman, MD PhD, Principal investigator, British Columbia Cancer AgencyAly Karsan, MD, Principal investigator, BC Cancer Agency, Molecular Diagnostic Laboraotry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010047
- Sponsor's protocol ID
- PCRTALK
- Acronym
- PCRTALK
- Status last verified
- Jul 2014
- First submitted
- 5 Dec 2013
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare the Performance of a qPCR-based Assay to Immunohistochemistry (IHC) and Fluorescence in Situ Hybridization (FISH) in the Detection of Anaplastic Lymphoma Kinase (ALK) Fusion Mutations in Formalin Fixed Paraffin-embedded (FFPE) Tissue From Non-small Cell Lung Cancer (NSCLC) Patients.
- ClinicalTrials.gov ID
- NCT02010047
- Acronym / sponsor ID
- PCRTALK / PCRTALK
- Conditions
- Nonsmall Cell Lung Cancer
- Keywords
- Anaplastic lymphoma kinase gene, Polymerase chain reaction, Immunohistochemistry, Fluorescence in situ hybridization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Insight Genetics
- Study start
- Dec 2013
- Primary completion
- 18 Aug 2015 (actual)
- Study completion
- 18 Aug 2015 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IHC, FISH and qPCR ALK assays | Experimental | Device: ALK qPCR assayALK testing by IHC and FISH will be compared to ALK qPCR testing on NSCLC FFPE tissue. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALK qPCR assay72 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. | Device | IHC, FISH and qPCR ALK assays |
Primary outcome
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.
Time frame: Up to 24 weeks after the completing of enrollment of 72 ALK negative and 72 ALK positive tumor blocks
1 secondary outcome
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.
Time frame: After completion of enrollemnt of 72 ALK postive tumor blocks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L Saltman, MD PhD principal investigator
British Columbia Cancer Agency
Aly Karsan, MD principal investigator
BC Cancer Agency, Molecular Diagnostic Laboraotry
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALK qPCR assay in people with Nonsmall Cell Lung Cancer, run by British Columbia Cancer Agency at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to 24 weeks after the completing of enrollment of 72 ALK negative and 72 ALK positive tumor blocks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.