NCT04178889

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
850

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

4.9 years

First QC Date

November 24, 2019

Last Update Submit

March 24, 2021

Conditions

Lung Cancer

Keywords

Lung cancerNon-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • To collect blood samples from the cohort of patients.

    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.

    Identify original diagnostic sample at recruitment.

  • To collect surplus diagnostic tissue from new cancer occurrences or relapse from the cohort of patients

    From recruitment to end of study (or 5 year follow up point, whichever comes first)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Papworth Hospital

Cambridge, United Kingdom

RECRUITING

Related 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.

    PMID: 30777897BACKGROUND

  • 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.

    PMID: 28233803BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be processed and separated into various components for storage, before batched analysis. Consent will be sought for the sample components to be kept for up to 15 years following the end of the study.

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Robert Rintoul, PhD FRCP

    Royal Papworth Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Rintoul, PhD FRCP

CONTACT

01223 639638robert.rintoul@nhs.net

Sarah Fielding, PhD

CONTACT

01223 639719sarah.fielding2@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2019

First Posted

November 26, 2019

Study Start

January 1, 2020

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

GB(1)