Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2015-01-31
2020-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Surgical Cohort
Surgical Cohort: Patients offered surgery, with or without adjuvant chemotherapy.
Blood sampling
Blood samples will be obtained during routine clinical visits. Ideally, two 9mL blood samples (or equivalent volume) will be collected into EDTA or other appropriate blood collection tube at each time point except at baseline, where three EDTA 9mL tubes and one of 2.6mL (for study of whole blood) will be collected.
Surplus Tumour Tissue sample collection from surgery
In surgical patients, lung tumour samples and normal lung tissue will be obtained from surplus tissue removed at the time of surgery. No extra procedures (biopsies or surgeries) are requested for the study.
Collection or archival tumour tissue (If available)
Where available surplus tumour and normal tissue from archival tissue will be collected for analysis.
Non Surgical Cohort
Non-Surgical Cohort: Stage I/II/IIIB patients undergoing radical radiotherapy (with or without chemotherapy) or stereotactic ablative radiotherapy (SABR).
Blood sampling
Blood samples will be obtained during routine clinical visits. Ideally, two 9mL blood samples (or equivalent volume) will be collected into EDTA or other appropriate blood collection tube at each time point except at baseline, where three EDTA 9mL tubes and one of 2.6mL (for study of whole blood) will be collected.
Collection or archival tumour tissue (If available)
Where available surplus tumour and normal tissue from archival tissue will be collected for analysis.
Interventions
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Blood sampling
Blood samples will be obtained during routine clinical visits. Ideally, two 9mL blood samples (or equivalent volume) will be collected into EDTA or other appropriate blood collection tube at each time point except at baseline, where three EDTA 9mL tubes and one of 2.6mL (for study of whole blood) will be collected.
Surplus Tumour Tissue sample collection from surgery
In surgical patients, lung tumour samples and normal lung tissue will be obtained from surplus tissue removed at the time of surgery. No extra procedures (biopsies or surgeries) are requested for the study.
Collection or archival tumour tissue (If available)
Where available surplus tumour and normal tissue from archival tissue will be collected for analysis.
Eligibility Criteria
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Inclusion Criteria
* 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
Patients participating in other clinical studies are not precluded from entering the study; however they must meet all the eligibility criteria for this study.
18 Years
ALL
No
Sponsors
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Cambridge University Hospitals NHS Foundation Trust
OTHER
University of Cambridge
OTHER
CCTU- Cancer Theme
OTHER
Responsible Party
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CCTU- Cancer Theme
LUCID Trial Coordinator
Principal Investigators
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Nitzan Rosenfeld, PhD
Role: PRINCIPAL_INVESTIGATOR
CRUK-CI
Locations
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Cambridge Cancer Trials Centre
Cambridge, Cambridgeshire, United Kingdom
Countries
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Central Contacts
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Cambridge Clinical Trials Unit - Cancer Theme
Role: CONTACT
Facility Contacts
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Other Identifiers
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14/WM/1072
Identifier Type: OTHER
Identifier Source: secondary_id
LUCID
Identifier Type: -
Identifier Source: org_study_id
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