Second Primary Lung Cancer Cohort Study (SPORT)

Lung Cancer Clinical Trial

— SPORT  

Official title:

Second Primary Lung Cancer Cohort Study (SPORT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04178889
• Other study ID #: P02514
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 2024

Study information

• Verified date: March 2021
• Source: Papworth Hospital NHS Foundation Trust
• Contact: Robert Rintoul, PhD FRCP
• Phone: 01223 639638
• Email: robert.rintoul[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Measuring DNA in the blood which has come from the tumour, so called circulating tumour DNA (ctDNA), may be one way to do this.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
United Kingdom	Royal Papworth Hospital	Cambridge

Sponsors (3)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust	Cancer Research UK, University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years
Secondary	To collect blood samples from the cohort of patients.	Have the blood samples been collected at follow up visits.	From recruitment through to end of study (or 5 year follow up point, whichever comes first)
Secondary	To collect surplus diagnostic tissue from the cohort of patients.	To collect surplus diagnostic tissue from original non-small cell lung cancer.	Identify original diagnostic sample at recruitment.
Secondary	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.	From recruitment to end of study (or 5 year follow up point, whichever comes first)