Generation Of a Lung Biobank for Future Use

Cancer Clinical Trial

— GOLF  

Official title:

Generation Of a Lung Biobank for Future Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05234138
• Other study ID #: CCR4977
• Status: Recruiting
• Start date: October 31, 2019
• Est. completion date: October 31, 2023

Study information

• Verified date: January 2022
• Source: Royal Marsden NHS Foundation Trust
• Contact: Mary O'Brien
• Phone: 020 8642 6011
• Email: Lung.Trials[@]rmh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer
• Lung Cancer

Intervention

Other:
• Blood Sample
Blood Sample

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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