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

NCT02718651 | Completed DMC

• 3 other identifiers: 2015-1881-21-10-72-266-151-16-02-56-16
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

ALK rearrangement; Circulating tumor DNA; Plasma DNA; Non-small cell lung cancer; Tyrosine kinase inhibitors

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with ALK-translocated lung cancer

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Odense University Hospital: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples - plasma

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Peter Meldgaard, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 24, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 21, 2020

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)