LUCID - LUng Cancer CIrculating Tumour Dna Study (LUCID)

November 4, 2019 updated by: CCTU- Cancer Theme
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB20QQ
        • Recruiting
        • Cambridge Cancer Trials Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline blood sample

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline blood sample
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.
Blood samples will be taken at routine clinic visits through study completion, an average of 3 years.
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
Blood samples will be taken at relapse through study completion, an average of 3 years.
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
Lung tumour tissue will be collected from surgery through end of study, an average of 3 years.
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
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
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.
Blood samples will be taken at baseline, during treatment and at follow-up clinic visits, approximately every 3 months for 9 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CCTU- Cancer Theme

Collaborators

Cambridge University Hospitals NHS Foundation Trust
University of Cambridge

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUCID
  • 14/WM/1072 (Other Identifier: HRA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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