CancerGOLFNCT05234138
Generation Of a Lung Biobank for Future Use
An observational study of Cancer and Lung Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lung Cancer
- What is being tested?
- Blood Sample
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Oct 2019to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Royal Marsden Hospital NHS Foundation Trust (Sutton and Chelsea)
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden Hospital NHS Foundation Trust
London, SW3 6JJ
Ann Gandolfi, 02086613903, ann.gandolfi@rmh.nhs.uk
About this study
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.
Read the 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.
- Conditions
- Cancer, Lung Cancer
- Being tested
- Blood Sample
- Medical subject headings
- Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleOther
Blood Sample
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start31 Oct 2019
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234138
- Sponsor's protocol ID
- CCR4977
- Acronym
- GOLF
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2020
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation Of a Lung Biobank for Future Use
- ClinicalTrials.gov ID
- NCT05234138
- Acronym / sponsor ID
- GOLF / CCR4977
- Conditions
- Cancer, Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Royal Marsden Hospital NHS Foundation Trust (Sutton and Chelsea)
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood SampleBlood Sample | Other | – |
Primary outcome
Create a collection of blood samples in a Biobank for Future Use
Time frame: 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.
Feasibility as a Primary Endpoint
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Lung Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary O'Brien (020 8642 6011, Lung.Trials@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create a collection of blood samples in a Biobank for Future Use (time frame: 3 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.