Lung CancerSPORTNCT04178889
Second Primary Lung Cancer Cohort Study (SPORT)
An observational study of Lung Cancer, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Patients who have had curative treatment for lung cancer are at an increased risk of developing second primary lung cancers (and other cancers) over the next 10 years. Doctors need to develop better ways of monitoring patients during follow up so we can intervene as quickly as possible with further treatments. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Cancer
- How many people
- 850 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2020to Dec 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been treated with curative intent (surgery/(chemo)radiotherapy) for stage I to IIIA Non-small cell carcinoma, between two and five years ago.
Who may be able to join
- previous treatment with curative intent (surgery or radical (chemo)radiotherapy) for stage I-IIIA primary NSCLC
- at least two years post first treatment date of first primary NSCLC
- able to provide informed consent
Who cannot join
- Primary lung tumour was a carcinoid tumour
- in the opinion of the managing clinician, thought unlikely to survive 12 months from time of potential recruitment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Papworth Hospital
Cambridge
Sarah Fielding
About this study
Patients who have had curative treatment for lung cancer are at an increased risk of developing second primary lung cancers (and other cancers) over the next 10 years. Doctors need to develop better ways of monitoring patients during follow up so we can intervene as quickly as possible with further treatments. Measuring DNA in the blood which has come from the tumour, so called circulating tumour DNA (ctDNA), may be one way to do this.
Read the detailed description
This is a multi-centre, observational basic science study to follow patient who have undergone radical treatment, surgery or radiotherapy for Non-small Cell Lung Cancer (NSCLC) between two and five years previously. Following consent, participants will be asked to provide blood samples every six months for up to the next five years. Information from their routine clinical care, including information from any imaging, diagnostic tissue samples and blood tests will be collected. We will also request access to any original surplus diagnostic material, as well as future, excess tissue from diagnostic samples.
Blood samples will be analysed using various new scientific techniques looking to correlate emergence of new primary cancer (or recurrence of original NSCLC) with blood based markers.
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment of 850 patients who have undergone treatment with curative intent for stage 1 - 3A non-small cell lung cancer.
In order to:
collect baseline demographics, clinical and past medical history to obtain blood samples every 6 months after recruitment
to collect relevant imaging and clinical data as part of their on-going routine clinical care
Measured: 5 years
Secondary outcomes (3)
To collect blood samples from the cohort of patients.
Have the blood samples been collected at follow up visits.
Measured: From recruitment through to end of study (or 5 year follow up point, whichever comes first)
To collect surplus diagnostic tissue from the cohort of patients.
To collect surplus diagnostic tissue from original non-small cell lung cancer.
Measured: Identify original diagnostic sample at recruitment.
To collect surplus diagnostic tissue from new cancer occurrences or relapse from the cohort of patients
Collection of surplus diagnostic tissue if any second primary cancer or recurrence occurs.
Measured: From recruitment to end of study (or 5 year follow up point, whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Jan 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Cancer Research UK, University of Cambridge
- Responsible party
- Sponsor
- Investigators
- Robert Rintoul, PhD FRCP, Principal investigator, Royal Papworth Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178889
- Sponsor's protocol ID
- P02514
- Acronym
- SPORT
- Status last verified
- Mar 2021
- First submitted
- 24 Nov 2019
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The only clinical data available to researchers will be anonymised. Permission will be sought at consent to retain data sets for up to 15 years at the end of the study to use for this study or other ethically approved studies.
Publications
Barclay ME, Lyratzopoulos G, Walter FM, Jefferies S, Peake MD, Rintoul RC. Incidence of second and higher order smoking-related primary cancers following lung cancer: a population-based cohort study. Thorax. 2019 May;74(5):466-472. doi: 10.1136/thoraxjnl-2018-212456. Epub 2019 Feb 18.
PubMed 30777897Wan JCM, Massie C, Garcia-Corbacho J, Mouliere F, Brenton JD, Caldas C, Pacey S, Baird R, Rosenfeld N. Liquid biopsies come of age: towards implementation of circulating tumour DNA. Nat Rev Cancer. 2017 Apr;17(4):223-238. doi: 10.1038/nrc.2017.7. Epub 2017 Feb 24.
PubMed 28233803
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Primary Lung Cancer Cohort Study (SPORT)
- ClinicalTrials.gov ID
- NCT04178889
- Acronym / sponsor ID
- SPORT / P02514
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- Cancer Research UK, University of Cambridge
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Nov 2019 (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.
Patients who have had curative treatment for lung cancer are at an increased risk of developing second primary lung cancers (and other cancers) over the next 10 years. Doctors need to develop better ways of monitoring patients during follow up so we can intervene as quickly as possible with further treatments. Measuring DNA in the blood which has come from the tumour, so called circulating tumour DNA (ctDNA), may be one way to do this.
Detailed description
This is a multi-centre, observational basic science study to follow patient who have undergone radical treatment, surgery or radiotherapy for Non-small Cell Lung Cancer (NSCLC) between two and five years previously. Following consent, participants will be asked to provide blood samples every six months for up to the next five years. Information from their routine clinical care, including information from any imaging, diagnostic tissue samples and blood tests will be collected. We will also request access to any original surplus diagnostic material, as well as future, excess tissue from diagnostic samples.
Blood samples will be analysed using various new scientific techniques looking to correlate emergence of new primary cancer (or recurrence of original NSCLC) with blood based markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been treated with curative intent (surgery/(chemo)radiotherapy) for stage I to IIIA Non-small cell carcinoma, between two and five years ago.
Key inclusion criteria (3 listed)
- previous treatment with curative intent (surgery or radical (chemo)radiotherapy) for stage I-IIIA primary NSCLC
- at least two years post first treatment date of first primary NSCLC
- able to provide informed consent
Key exclusion criteria (2 listed)
- Primary lung tumour was a carcinoid tumour
- in the opinion of the managing clinician, thought unlikely to survive 12 months from time of potential recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recruitment of 850 patients who have undergone treatment with curative intent for stage 1 - 3A non-small cell lung cancer.
Time frame: 5 years
In order to: collect baseline demographics, clinical and past medical history to obtain blood samples every 6 months after recruitment to collect relevant imaging and clinical data as part of their on-going routine clinical care
3 secondary outcomes
To collect blood samples from the cohort of patients.
Time frame: From recruitment through to end of study (or 5 year follow up point, whichever comes first)
To collect surplus diagnostic tissue from the cohort of patients.
Time frame: Identify original diagnostic sample at recruitment.
To collect surplus diagnostic tissue from new cancer occurrences or relapse from the cohort of patients
Time frame: From recruitment to end of study (or 5 year follow up point, whichever comes first)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Background: PubMed 30777897Barclay ME, Lyratzopoulos G, Walter FM, Jefferies S, Peake MD, Rintoul RC. Incidence of second and higher order smoking-related primary cancers following lung cancer: a population-based cohort study. Thorax. 2019 May;74(5):466-472. doi: 10.1136/thoraxjnl-2018-212456. Epub 2019 Feb 18.
- Background: PubMed 28233803Wan JCM, Massie C, Garcia-Corbacho J, Mouliere F, Brenton JD, Caldas C, Pacey S, Baird R, Rosenfeld N. Liquid biopsies come of age: towards implementation of circulating tumour DNA. Nat Rev Cancer. 2017 Apr;17(4):223-238. doi: 10.1038/nrc.2017.7. Epub 2017 Feb 24.
- Individual participant dataSharing planned: No. The only clinical data available to researchers will be anonymised. Permission will be sought at consent to retain data sets for up to 15 years at the end of the study to use for this study or other ethically approved studies.
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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.
Robert Rintoul, PhD FRCP principal investigator
Royal Papworth Hospital NHS Trust
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 Lung Cancer, run by Papworth Hospital 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 3 inclusion and 2 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 25 Mar 2021. 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 Robert Rintoul, PhD FRCP (01223 639638, robert.rintoul@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment of 850 patients who have undergone treatment with curative intent for stage 1 - 3A non-small cell lung cancer. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178889, which also lists 2 linked publications.
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 25 Mar 2021.