Generation Of a Lung Biobank for Future Use

NCT05234138 | Unknown

• 1 other identifier: CCR4977
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to invite 1,000 patients with symptoms triggering the lung cancer diagnostic pathway or with significant risks of lung cancer, referred to The Royal Marsden NHS Foundation Trust (RMH) referral centres (Kingston Hospital NHS Foundation Trust, Epsom and St Helier University Hospitals NHS Trust, Croydon University Hospitals NHS Foundation Trust or St George's University Hospitals NHS Foundation Trust) over a 1 year period, to complete a life style questionnaire, document lung function tests and to donate a blood sample for storage with a view to testing for a genetic signature and other biomarkers in future studies from this established biobank.

Conditions

Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Create a collection of blood samples in a Biobank for Future Use

  The aim is to ask 1,000 patients with symptoms triggering the lung cancer diagnostic pathway or with significant risks of lung cancer and to create a collection of blood samples in a Biobank for Future Use.

  3 Years

• Feasibility as a Primary Endpoint

  Feasibility will be reported as the primary endpoint, where we expect 50% of patients would be willing to give a blood sample- i.e. 250/year for 2 years and thus a biobank will be established.

  3 Years

Interventions

Blood Sample OTHER

Blood Sample

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

Royal Marsden Hospital NHS Foundation Trust (Sutton and Chelsea)

You may qualify if:

• One of the following criteria:
• Patients with lung cancer at any stage or time in their disease.
• Patients without lung cancer who have been referred by the TWR pathway.
• Patients without lung cancer who have radiological changes on their X-Ray or CT scan that need follow up.
• Patients without lung cancer who have a strong family history of lung cancer. PLUS
• Patients aged \>18 Years
• Patients who have signed informed consent form

You may not qualify if:

• Unable to provide informed consent.
• Bleeding disorder or other medical condition that would make a blood sample hazardous.
• Within 3 weeks of chemotherapy or radiotherapy (as low lymphocyte may be associated with poor DNA yield).

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden Hospital NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

EDTA and Streck (40ml)

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Mary O'Brien

CONTACT

020 8642 6011; Lung.Trials@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: February 10, 2022
• Study Start: October 31, 2019
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2023
• Last Updated: February 10, 2022

Record last verified: 2022-01

Locations

GB (1)