LUCID - LUng Cancer CIrculating Tumour Dna Study

CCTU- Cancer Theme

Status: Unknown

Conditions: Non Small Cell Lung Cancer

Treatments: Procedure: Blood sampling; Procedure: Surplus Tumour Tissue sample collection from surgery; Other: Collection or archival tumour tissue (If available)

Study type: Observational

Funder types: Other

Identifiers

NCT04153526

14/WM/1072 (Other Identifier)

LUCID

Details and patient eligibility

About

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.

Full 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: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Surgical Cohort

Description:

Surgical Cohort: Patients offered surgery, with or without adjuvant chemotherapy.

Treatment:

Procedure: Blood sampling

Procedure: Surplus Tumour Tissue sample collection from surgery

Other: Collection or archival tumour tissue (If available)

Non Surgical Cohort

Description:

Non-Surgical Cohort: Stage I/II/IIIB patients undergoing radical radiotherapy (with or without chemotherapy) or stereotactic ablative radiotherapy (SABR).

Treatment:

Procedure: Blood sampling

Other: Collection or archival tumour tissue (If available)