Clinical trial NCT04153526: LUCID - LUng Cancer CIrculating Tumour Dna Study
Official title: LUCID - LUng Cancer CIrculating Tumour Dna Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Cambridge University Hospitals NHS Foundation Trust
name: University of Cambridge
First posted: 2019-11-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non small cell lung cancer patients planned for treatment with curative intent

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.

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.

Primary outcomes:
measure: ctDNA detection rate in all patients
timeFrame: Baseline blood sample
Secondary outcomes:
measure: ctDNA baseline levels, genetic alterations and other features in all patients
timeFrame: Baseline blood sample
measure: ctDNA levels, genetic alterations and other characteristics with clinical features in all patients
timeFrame: Blood samples will be taken at routine clinic visits through study completion, an average of 3 years.
measure: Comparison of ctDNA levels and mutation profile at relapse to that obtained at earlier time points
timeFrame: Blood samples will be taken at relapse through study completion, an average of 3 years.
measure: Correlate the genetic alterations found in different regions of each tumour with histological features and genetic alterations in the ctDNA
timeFrame: Lung tumour tissue will be collected from surgery through end of study, an average of 3 years.
measure: Test ctDNA levels, genetic alterations or other characteristics during and after treatment with radical radiotherapy
timeFrame: Blood samples will be taken every week of radiotherapy and at follow-up clinic visits, approximately every 3 months for 9 months after the end of treatment
measure: Establish a library of samples for future analysis
timeFrame: Blood samples will be taken at baseline, during treatment and at follow-up clinic visits, approximately every 3 months for 9 months after treatment
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge Cancer Trials Centre
state: Cambridgeshire
Study officials:
affiliation: CRUK-CI
name: Nitzan Rosenfeld, PhD
role: PRINCIPAL_INVESTIGATOR
References: