Non Small Cell Lung CancerLUCIDNCT04153526
LUCID - LUng Cancer CIrculating Tumour Dna Study
An observational study of Non Small Cell Lung Cancer, run by CCTU- Cancer Theme at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Blood sampling, Surplus Tumour Tissue sample collection from surgery and Collection or archival tumour tissue (If available)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non small cell lung cancer patients planned for treatment with curative intent
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Cambridge Clinical Trials Unit - Cancer Theme contact
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge Cancer Trials Centre
Cambridge, Cambridgeshire, CB20QQ
Early Phase Team, Cambridge Cancer Trials Centre, cctc@addenbrookes.nhs.uk
About this study
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.
Read the 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
- Being tested
- Blood sampling, Surplus Tumour Tissue sample collection from surgery, Collection or archival tumour tissue (If available)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
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.
Surplus Tumour Tissue sample collection from surgeryProcedure or 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.
Collection or archival tumour tissue (If available)Other
Where available surplus tumour and normal tissue from archival tissue will be collected for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Cohort | Surgical Cohort: Patients offered surgery, with or without adjuvant chemotherapy. Receives: Procedure: Blood sampling; Procedure: Surplus Tumour Tissue sample collection from surgery; Other: Collection or archival tumour tissue (If available) | |
| Non Surgical Cohort | Non-Surgical Cohort: Stage I/II/IIIB patients undergoing radical radiotherapy (with or without chemotherapy) or stereotactic ablative radiotherapy (SABR). Receives: Procedure: Blood sampling; Other: Collection or archival tumour tissue (If available) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA detection rate in all patients
The primary endpoint is the ctDNA detection rate in the baseline blood sample of early stage NSCLC patients undergoing treatment with curative intent.
Measured: Baseline blood sample
Secondary outcomes (6)
ctDNA baseline levels, genetic alterations and other features in all patients
To quantify the baseline levels, genetic alterations and other features of ctDNA in patients with NSCLC undergoing treatment with curative intent
Measured: Baseline blood sample
ctDNA levels, genetic alterations and other characteristics with clinical features in all patients
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.
Measured: 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
To compare the ctDNA levels and mutation profile at relapse to that obtained at earlier time points
Measured: 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
To correlate the genetic alterations found in different regions of each tumour with histological features and genetic alterations in the ctDNA
Measured: 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
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
Measured: 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
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.
Measured: Blood samples will be taken at baseline, during treatment and at follow-up clinic visits, approximately every 3 months for 9 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study startJan 2015
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCTU- Cancer Theme
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, University of Cambridge
- Responsible party
- Sponsor-investigator, CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Nitzan Rosenfeld, PhD, Principal investigator, CRUK-CI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153526
- Sponsor's protocol ID
- LUCID
- Other IDs
- 14/WM/1072
- Acronym
- LUCID
- Status last verified
- Nov 2019
- First submitted
- 21 Jan 2015
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUCID - LUng Cancer CIrculating Tumour Dna Study
- ClinicalTrials.gov ID
- NCT04153526
- Acronym / sponsor ID
- LUCID / LUCID
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CCTU- Cancer ThemeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, University of Cambridge
- Study start
- Jan 2015
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Cohort | – | Procedure: Blood sampling, Procedure: Surplus Tumour Tissue sample collection from surgery, Other: Collection or archival tumour tissue (If available)Surgical Cohort: Patients offered surgery, with or without adjuvant chemotherapy. |
| Non Surgical Cohort | – | Procedure: Blood sampling, Other: Collection or archival tumour tissue (If available)Non-Surgical Cohort: Stage I/II/IIIB patients undergoing radical radiotherapy (with or without chemotherapy) or stereotactic ablative radiotherapy (SABR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non small cell lung cancer patients planned for treatment with curative intent
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood 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 or surgery | Non Surgical Cohort, Surgical Cohort |
| Surplus Tumour Tissue sample collection from surgeryIn 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. | Procedure or surgery | Surgical Cohort |
| Collection or archival tumour tissue (If available)Where available surplus tumour and normal tissue from archival tissue will be collected for analysis. | Other | Non Surgical Cohort, Surgical Cohort |
Primary outcome
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.
6 secondary outcomes
ctDNA baseline levels, genetic alterations and other features in all patients
Time frame: 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.
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.
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.
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cambridge Clinical Trials Unit - Cancer Theme contact
Nitzan Rosenfeld, PhD principal investigator
CRUK-CI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by CCTU- Cancer Theme at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cambridge Clinical Trials Unit - Cancer Theme, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA detection rate in all patients (time frame: Baseline blood sample). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.