Clinical trial NCT04178889: Second Primary Lung Cancer Cohort Study (SPORT)
Official title: Second Primary Lung Cancer Cohort Study (SPORT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Lung cancer
Non-small cell lung cancer
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Cancer Research UK
name: University of Cambridge
First posted: 2019-11-26
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Recruitment of 850 patients who have undergone treatment with curative intent for stage 1 - 3A non-small cell lung cancer.
timeFrame: 5 years
Secondary outcomes:
measure: To collect blood samples from the cohort of patients.
timeFrame: From recruitment through to end of study (or 5 year follow up point, whichever comes first)
measure: To collect surplus diagnostic tissue from the cohort of patients.
timeFrame: Identify original diagnostic sample at recruitment.
measure: To collect surplus diagnostic tissue from new cancer occurrences or relapse from the cohort of patients
timeFrame: From recruitment to end of study (or 5 year follow up point, whichever comes first)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
Study officials:
affiliation: Royal Papworth Hospital NHS Trust
name: Robert Rintoul, PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wan 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.