LUCID - LUng Cancer CIrculating Tumour Dna Study

NCT ID: NCT04153526

Last Updated: 2019-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-02-29

Brief Summary

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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

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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

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical Cohort

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

Blood sampling

Intervention Type PROCEDURE

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 surgery

Intervention Type PROCEDURE

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)

Intervention Type OTHER

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).

Blood sampling

Intervention Type PROCEDURE

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.

Collection or archival tumour tissue (If available)

Intervention Type OTHER

Where available surplus tumour and normal tissue from archival tissue will be collected for analysis.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Collection or archival tumour tissue (If available)

Where available surplus tumour and normal tissue from archival tissue will be collected for analysis.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role collaborator

CCTU- Cancer Theme

OTHER

Sponsor Role lead

Responsible Party

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CCTU- Cancer Theme

LUCID Trial Coordinator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nitzan Rosenfeld, PhD

Role: PRINCIPAL_INVESTIGATOR

CRUK-CI

Locations

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Cambridge Cancer Trials Centre

Cambridge, Cambridgeshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Cambridge Clinical Trials Unit - Cancer Theme

Role: CONTACT

Facility Contacts

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Early Phase Team, Cambridge Cancer Trials Centre

Role: primary

Other Identifiers

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14/WM/1072

Identifier Type: OTHER

Identifier Source: secondary_id

LUCID

Identifier Type: -

Identifier Source: org_study_id

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