LUCID - LUng Cancer CIrculating Tumour Dna Study
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Procedure: Blood samplingProcedure: Surplus Tumour Tissue sample collection from surgeryOther: Collection or archival tumour tissue (If available)
- Registration Number
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Surgical Cohort Blood sampling Surgical Cohort: Patients offered surgery, with or without adjuvant chemotherapy. Surgical Cohort Surplus Tumour Tissue sample collection from surgery Surgical Cohort: Patients offered surgery, with or without adjuvant chemotherapy. Surgical Cohort Collection or archival tumour tissue (If available) Surgical Cohort: Patients offered surgery, with or without adjuvant chemotherapy. Non Surgical Cohort Blood sampling Non-Surgical Cohort: Stage I/II/IIIB patients undergoing radical radiotherapy (with or without chemotherapy) or stereotactic ablative radiotherapy (SABR). Non Surgical Cohort Collection or archival tumour tissue (If available) Non-Surgical Cohort: Stage I/II/IIIB patients undergoing radical radiotherapy (with or without chemotherapy) or stereotactic ablative radiotherapy (SABR).
- Primary Outcome Measures
Name Time Method ctDNA detection rate in all patients Baseline blood sample The primary endpoint is the ctDNA detection rate in the baseline blood sample of early stage NSCLC patients undergoing treatment with curative intent.
- Secondary Outcome Measures
Name Time Method ctDNA baseline levels, genetic alterations and other features in all patients Baseline blood sample To quantify the baseline levels, genetic alterations and other features of ctDNA in patients with NSCLC undergoing treatment with curative intent
ctDNA levels, genetic alterations and other characteristics with clinical features in all patients Blood samples will be taken at routine clinic visits through study completion, an average of 3 years. To correlate ctDNA levels (fraction and/or absolute amplifiable copies), genetic alterations and other ctDNA characteristics with clinical features such as response to treatment, burden of disease (as evaluated by, e.g. radiology, pathology or performance status), disease relapse and future outcomes.
Comparison of ctDNA levels and mutation profile at relapse to that obtained at earlier time points Blood samples will be taken at relapse through study completion, an average of 3 years. To compare the ctDNA levels and mutation profile at relapse to that obtained at earlier time points
Correlate the genetic alterations found in different regions of each tumour with histological features and genetic alterations in the ctDNA Lung tumour tissue will be collected from surgery through end of study, an average of 3 years. To correlate the genetic alterations found in different regions of each tumour with histological features and genetic alterations in the ctDNA
Test ctDNA levels, genetic alterations or other characteristics during and after treatment with radical radiotherapy 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 To test ctDNA levels, genetic alterations or other characteristics, before, during and after treatment with radical radiotherapy (with or without chemotherapy) and to correlate them with clinical features, e.g. response to treatment and clinical outcomes
Establish a library of samples for future analysis Blood samples will be taken at baseline, during treatment and at follow-up clinic visits, approximately every 3 months for 9 months after treatment To establish a library of samples for future analysis using more advanced technology, i.e. to achieve a more detailed retrospective analysis of ctDNA levels and genomic alterations/features in relation to clinical outcomes.
Trial Locations
- Locations (1)
Cambridge Cancer Trials Centre
🇬🇧Cambridge, Cambridgeshire, United Kingdom