Second Primary Lung Cancer Cohort Study (SPORT)

NCT ID: NCT04178889

Last Updated: 2021-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research UK

OTHER

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role collaborator

Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Rintoul, PhD FRCP

Role: PRINCIPAL_INVESTIGATOR

Royal Papworth Hospital NHS Trust

Locations

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Royal Papworth Hospital

Cambridge, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Robert Rintoul, PhD FRCP

Role: CONTACT

01223 639638

Sarah Fielding, PhD

Role: CONTACT

01223 639719

Facility Contacts

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Sarah Fielding

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30777897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28233803 (View on PubMed)

Other Identifiers

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P02514

Identifier Type: -

Identifier Source: org_study_id

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