Official Title
LUCID - LUng Cancer CIrculating Tumour Dna Study
Brief Title
LUCID - LUng Cancer CIrculating Tumour Dna Study
Protocol ID
NCT04153526
Lead Sponsor
CCTU- Cancer Theme
Brief Summary
This is a prospective observational pilot study to investigate levels of circulating
tumour DNA (ctDNA) in plasma from patients with stage I to IIIB non-small cell lung
cancer (NSCLC) who will undergo treatment with curative intent.
Detailed Description
Taking as reference tumour-specific somatic genetic alterations identified within
individual cancer biopsies from patients, recent advances in genomic and next generation
sequencing technologies now provide the opportunity to investigate whether each patient's
tumour-specific DNA can be reliably detected within their plasma. This offers the
possibility to test a patient's response following treatment with curative intent. This
technology has already been used to detect ctDNA in metastatic NSCLC, but not yet in
early stage disease.
The primary objective of this pilot study is to test the feasibility of detecting serial
ctDNA levels in stage I to IIIB NSCLC patients who undergo treatment with curative
intent. As secondary endpoints, this study aims to measure ctDNA levels and
characteristics, and to correlate them with clinical features (such as burden of disease
and treatment response) in order to test the value of ctDNA as a diagnostic, prognostic
and predictive biomarker for patients with NSCLC.
100 patients planned for curative treatment (surgery or radical radiotherapy +/-
chemotherapy) will be recruited.
Enrollment Count
100 participants
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old at the time of consent
- Male or Female
- Patients with radiologically and histologically/cytologically confirmed stages I to
IIIB NSCLC who are planning to undergo radical treatment (surgery or radical
radiotherapy) with curative intent
- ECOG Performance Status 0-2
- Able to give informed consent
- Able to give blood
Exclusion Criteria:
- Unable to receive treatment with curative intent due to co-morbidity or personal
choice
Patients participating in other clinical studies are not precluded from entering the
study; however they must meet all the eligibility criteria for this study.
Filters
Non Small Cell Lung Cancer
UNKNOWN
ADULT
OLDER_ADULT