Ignite Creation Date:
2024-05-06 @ 8:19 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02718651
Status:
COMPLETED
Last Update Posted:
2020-02-21
First Post:
2016-03-18
Brief Title:
Blood-based Identification and Monitoring of Patients With ALK-translocated Lung Cancer
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Identification of Response to ALK-targeted Treatment in Lung Cancer Patients by Monitoring Tumor DNA in Blood Samples
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1-16-02-56-16 | OTHER | Danish Data Protection Agency | None |
| 1-10-72-266-15 | OTHER | None | None |