Second Primary Lung Cancer Cohort Study (SPORT) (SPORT)

March 24, 2021 updated by: Papworth Hospital NHS Foundation Trust
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

850

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom
        • Recruiting
        • Royal Papworth Hospital
        • Contact:
          • Sarah Fielding

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
To collect surplus diagnostic tissue from the cohort of patients.
Time Frame: Identify original diagnostic sample at recruitment.
To collect surplus diagnostic tissue from original non-small cell lung cancer.
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papworth Hospital NHS Foundation Trust

Collaborators

Cancer Research UK
University of Cambridge

Investigators

  • Principal Investigator: Robert Rintoul, PhD FRCP, Royal Papworth Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

November 24, 2019

First Submitted That Met QC Criteria

November 24, 2019

First Posted (ACTUAL)

November 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P02514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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