Targeted therapies guided by molecular diagnostics have become a standard treatment of lung cancer. Nowadays, tumour tissue is required to assess the molecular characteristics of the tumour. However, the procedures to obtain tissue are invasive and…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of this study is to implement the ctDNA analysis to identify
actionable targets in lung tumors.
We envision this study will create awareness in regional hospitals with this
novel test method.
Secondary outcome
1. Percentage of patients identified as having an activating and targetable
genetic alteration as determined by tissue and liquid biopsies with an
intra-individual comparison of the presence of driver mutations detected in
tissue and liquid biopsies.
2. To get insight in the time it takes from diangosis to start of targeted
treatment.
3. The percentage of patient with inadequate tissue for analysis where ctDNA
may be an alternative.
4. Exploring cost- effectiveness
Background summary
Lung cancer is the second most common cancer and the leading cause of cancer
deaths for men and women, In 2019, 9.843 patients were diagnosed with non-small
cell lung cancer (NSCLC) in the Netherlands. Despite recent advances made in
diagnosis and treatment strategies, NSCLC prognosis remains poor, with a 5-yr
overall survival of 15%. In recent years, new methods have been developed for
high-throughput molecular analysis of tumours and have provided markers as
powerful tools for the development of innovative diagnostic and therapeutic
strategies in cancer. Genomic studies have been pioneering in providing
information on lung cancer molecular biology, followed by clear evidence that
genetic alterations are driving carcinogenesis. Activating somatic mutations
including point substitution, small insertion, and in-frame deletion are major
oncogenic drivers in lung cancer.
Study objective
Targeted therapies guided by molecular diagnostics have become a standard
treatment of lung cancer. Nowadays, tumour tissue is required to assess the
molecular characteristics of the tumour. However, the procedures to obtain
tissue are invasive and with a concomitant risk of adverse events. A liquid
biopsy, which assess circulating tumor DNA (ctDNA) from peripheral blood, may
be an alternative for the majority of NSCLC patients.
Nonetheless, ctDNA analysis is not commonly requested in clinical practice due
to limited knowhow, experience, availability or lacking logistics. This study
aims to implement ctDNA analysis in daily clinical care by adding the logistics
needed for this novel test to the regular clinical practice.
Study design
The LICA study is a multicenter trial in which ctDNA analysis will be performed
using prospectively collected plasma samples.
At the moment of diagnosis, a single blood draw of 25mL will be requested. In
the majority of patients, a tissue biopsy will also be performed as part of the
regular clinical care. When there is a high suspicion for stage III/IV disease
based on imaging, the ctDNA from plasma will be analyzed. The interpretation of
the ctDNA analysis will be independent of the biopsy results and will be
reported to the treating physician at a later stage.
Study burden and risks
A sample of blood will be drawn for molecular profiling purposes. This will be
combined with a scheduled blood drawing if possible.
The burden and risks associated with this study are thought to be in balance
with the aim to implement this blood based test in the future to replace
invasive tissue obtaining procedures.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
• Patients with confirmed or suspected non-small cell lung cancer
• Signed informed consent
• Adult (>= 18 years of age) and mentally competent
Exclusion criteria
• Patients with a benign lesion
• Patients with a metastasis of another primary cancer than lung cancer
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76613.091.21 |