NCT04153526

LUCID - LUng Cancer CIrculating Tumour Dna Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: CCTU- Cancer Theme · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.
OTHER	Collection or archival tumour tissue (If available)	Where available surplus tumour and normal tissue from archival tissue will be collected for analysis.

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2019-11-06
• Last updated: 2019-11-06

Locations

1 site across 1 country: United Kingdom