LUCID - LUng Cancer CIrculating Tumour Dna Study

NCT04153526 | Unknown

• 2 other identifiers: LUCID14/WM/1072
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline blood sample

Secondary Outcomes (6)

• ctDNA baseline levels, genetic alterations and other features in all patients

  Baseline blood sample

• ctDNA levels, genetic alterations and other characteristics with clinical features in all patients

  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

  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

  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

  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

Study Arms (2)

Surgical Cohort

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

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).

Procedure: Blood sampling; Other: Collection or archival tumour tissue (If available)

Interventions

Blood sampling 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.

Non Surgical Cohort; Surgical Cohort

Surplus Tumour Tissue sample collection from surgery 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.

Surgical Cohort

Collection or archival tumour tissue (If available) OTHER

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

Non Surgical Cohort; Surgical Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CCTU- Cancer Theme: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• University of Cambridge: collaborator

Study Sites (1)

Cambridge Cancer Trials Centre

Cambridge, Cambridgeshire, CB20QQ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nitzan Rosenfeld, PhD

  CRUK-CI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cambridge Clinical Trials Unit - Cancer Theme

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: LUCID Trial Coordinator

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: November 6, 2019
• Study Start: January 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: November 6, 2019

Record last verified: 2019-11

Locations

GB (1)