Blood-based Identification and Monitoring of Patients With ALK-translocated Lung Cancer
NCT ID: NCT02718651
Last Updated: 2020-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2016-03-31
2018-12-31
Brief Summary
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The aim of this study is to use a new diagnostic test to detect ALK rearrangements using next generation sequencing, which will improve the diagnosis and treatment of ALK-positive NSCLC patients. Furthermore, this test will be performed on blood samples, making it minimally invasive for the patients. It is our believe that circulating tumor DNA (ctDNA) in blood can be employed as an easy accessible and comprehensive source of information to diagnose ALK-positive disease, but also as a means of monitoring patient response during treatment. Quantitation of the the amount of ALK rearrangement will give information about which patients benefit from treatment and when treatment is no longer effective. The project will be a multicenter study where blood samples will be collected every 6 weeks from patients treated at four major hospitals in Denmark.
This study will benefit future patients with lung cancer, as it will improve both the monitoring and evaluation of their treatment. Monitoring patients during treatment will provide more knowledge of disease progression and the effect of ALK-TKI treatment, contributing to a greater selection of patients, who will respond to treatment. This will potentially allow effective treatment to continue longer than with conventional methods
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Biopsy-verified ALK-translocation
Exclusion Criteria
* Patients with squamous cell carcinoma
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Odense University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Peter Meldgaard, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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Other Identifiers
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1-10-72-266-15
Identifier Type: OTHER
Identifier Source: secondary_id
1-16-02-56-16
Identifier Type: OTHER
Identifier Source: secondary_id
2015-1881-2
Identifier Type: -
Identifier Source: org_study_id
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