Clinical trial · Observational

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

Identification of Response to ALK-targeted Treatment in Lung Cancer Patients by Monitoring Tumor DNA in Blood Samples

NCT02718651CI-TRIAL-00043550completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Carcinoma, Non-Small-Cell Lung	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Progression-free survival
timeFrame
2 years

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Non-small cell lung cancer diagnosis
* Biopsy-verified ALK-translocation

Exclusion Criteria:

* Patients were it is not possible to retrieve a biopsy
* Patients with squamous cell carcinoma

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Mar 1, 2016
Primary completion: Dec 1, 2018
Completion: Dec 1, 2018
First posted: Mar 24, 2016
Last update posted: Feb 21, 2020
Enrollment: 70 (estimated)
Lead sponsor: University of Aarhus OTHER
Collaborators: Aarhus University Hospital; Aalborg University Hospital; Odense University Hospital
Keywords: ALK rearrangement, Circulating tumor DNA, Plasma DNA, Non-small cell lung cancer, Tyrosine kinase inhibitors

Data updated 22 days agoSource updated Feb 21, 2020source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
Denmark	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.