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LUCID - LUng Cancer CIrculating Tumour Dna Study (LUCID)

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.




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


Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153526


Contacts
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Contact: Cambridge Clinical Trials Unit - Cancer Theme

Locations
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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
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Principal Investigator: Nitzan Rosenfeld, PhD CRUK-CI
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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    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases