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Blood-based Identification and Monitoring of Patients With ALK-translocated Lung Cancer

NCT02718651 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2020-02-21

No results posted yet for this study

Summary

Genetic rearrangements in the Anaplastic Lymphoma Kinase (ALK) gene result in the creation of a variety of oncogenic fusion proteins that drive malignancy in a subset of non-small cell lung cancers (NSCLC) patients. Treatment with the ALK small tyrosine kinase inhibitor (TKI) crizotinib has produced remarkable results for ALK-positive patients, however the current diagnostic tests used in the clinic are not sufficiently detailed and require a tumor biopsy.

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

Conditions

  • Carcinoma, Non-Small-Cell Lung

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Peter Meldgaard, MD, PhD · Aarhus University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02718651 on ClinicalTrials.gov