Generation Of a Lung Biobank for Future Use (GOLF)

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Lung Cancer
• Intervention / Treatment: Other: Blood Sample

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Mary O'Brien; Phone Number: 020 8642 6011; Email: Lung.Trials@rmh.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • Recruiting
    • Royal Marsden Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Royal Marsden Hospital NHS Foundation Trust (Sutton and Chelsea)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2019
• Primary Completion (ANTICIPATED): October 31, 2022
• Study Completion (ANTICIPATED): October 31, 2023

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (ACTUAL): February 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CCR4977

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No