GOLF: Generation Of a Lung Biobank for Future Use

Sponsor
Royal Marsden NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT05234138
Collaborator
(none)
1,000
1
48
20.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Generation Of a Lung Biobank for Future Use
Actual Study Start Date :
Oct 31, 2019
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2023

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal Marsden Hospital NHS Foundation Trust London United Kingdom SW3 6JJ

Sponsors and Collaborators

  • Royal Marsden NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT05234138
Other Study ID Numbers:
  • CCR4977
First Posted:
Feb 10, 2022
Last Update Posted:
Feb 10, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 10, 2022