Generation Of a Lung Biobank for Future Use

• Conditions: Cancer; Lung Cancer

• Registration Number: NCT05234138
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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.

Detailed Description

Patients will have been referred under the two week rule (TWR) diagnostic pathway, some will have lung cancer, others not, and other patients will have had a diagnosis of lung cancer by other pathways i.e. non TWR.

There are 3 groups of patients:

Group A - lung cancer patients at any stage and by any non TWR pathway, n=250. Group B - lung cancer patients who were referred initially by the TWR pathway, n=150.

Group C - Subjects referred by the TWR pathway (i.e. with symptoms) who do not have lung cancer, or subjects referred by any pathway who do not have lung cancer but do have radiological changes (that need follow up) or a strong family history of lung cancer, n=600.

A strong family history for this study means 1 or more first degree relatives with lung cancer with at least one individual having lung cancer at age \<50 yrs.

Study Timeline

• Study Start: 2019-10-31
• Study First Submitted: 2020-01-13
• Status Verified: 2022-01
• Study First Submitted QC: 2022-02-08
• Last Update Submitted: 2022-02-08
• Study First Posted: 2022-02-10
• Last Update Posted: 2022-02-10
• Primary Completion: 2022-10-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility as a Primary Endpoint	3 Years	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.
Create a collection of blood samples in a Biobank for Future Use	3 Years	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.

Trial Locations

Locations (1)

Royal Marsden Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom