LUCID - LUng Cancer CIrculating Tumour Dna Study (LUCID)

• ClinicalTrials.gov Identifier: NCT04153526
• Recruitment Status: Unknown
• First Posted: November 6, 2019
• Last Update Posted: November 6, 2019
• Sponsor: CCTU- Cancer Theme
• Collaborators: Cambridge University Hospitals NHS Foundation Trust; University of Cambridge
• Information provided by (Responsible Party): CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust

Study Description

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.

Condition or disease	Intervention/treatment
Non Small Cell Lung Cancer	Procedure: Blood sampling; Procedure: Surplus Tumour Tissue sample collection from surgery; Other: Collection or archival tumour tissue (If available)

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: LUCID - LUng Cancer CIrculating Tumour Dna Study
• Study Start Date: January 2015
• Estimated Primary Completion Date: February 2020
• Estimated Study Completion Date: February 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Surgical Cohort; Surgical Cohort: Patients offered surgery, with or without adjuvant chemotherapy.	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.
Non Surgical Cohort; Non-Surgical Cohort: Stage I/II/IIIB patients undergoing radical radiotherapy (with or without chemotherapy) or stereotactic ablative radiotherapy (SABR).	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.; Other: Collection or archival tumour tissue (If available); Where available surplus tumour and normal tissue from archival tissue will be collected for analysis.

Outcome Measures

Primary Outcome Measures :

1. ctDNA detection rate in all patients [ Time Frame: 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 :

1. ctDNA baseline levels, genetic alterations and other features in all patients [ Time Frame: Baseline blood sample ]
   To quantify the baseline levels, genetic alterations and other features of ctDNA in patients with NSCLC undergoing treatment with curative intent
2. ctDNA levels, genetic alterations and other characteristics with clinical features in all patients [ Time Frame: 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.
3. Comparison of ctDNA levels and mutation profile at relapse to that obtained at earlier time points [ Time Frame: 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
4. Correlate the genetic alterations found in different regions of each tumour with histological features and genetic alterations in the ctDNA [ Time Frame: 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
5. Test ctDNA levels, genetic alterations or other characteristics during and after treatment with radical radiotherapy [ Time Frame: 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
6. Establish a library of samples for future analysis [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA

Tumour samples & normal tissue samples Blood samples CtDNA isolated from blood sample

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Non small cell lung cancer patients planned for treatment with curative intent

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.

Contacts and Locations

Contacts

Contact: Cambridge Clinical Trials Unit - Cancer Theme

Locations

United Kingdom

Cambridge Cancer Trials Centre; Recruiting

Cambridge, Cambridgeshire, United Kingdom, CB20QQ

Contact: Early Phase Team, Cambridge Cancer Trials Centre cctc@addenbrookes.nhs.uk

Sponsors and Collaborators

CCTU- Cancer Theme

Cambridge University Hospitals NHS Foundation Trust

University of Cambridge

Investigators

• Principal Investigator: Nitzan Rosenfeld, PhD; CRUK-CI

More Information

• Responsible Party: CCTU- Cancer Theme, LUCID Trial Coordinator, Cambridge University Hospitals NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04153526
• Other Study ID Numbers: LUCID; 14/WM/1072 ( Other Identifier: HRA )
• First Posted: November 6, 2019
• Last Update Posted: November 6, 2019
• Last Verified: November 2019

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases