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| Name | Class |
|---|---|
| Cancer Research UK | OTHER |
| University of Cambridge | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| To collect surplus diagnostic tissue from the cohort of patients. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Rintoul, PhD FRCP | Contact | 01223 639638 | robert.rintoul@nhs.net | |
| Sarah Fielding, PhD | Contact | 01223 639719 | sarah.fielding2@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Robert Rintoul, PhD FRCP | Royal Papworth Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Papworth Hospital | Recruiting | Cambridge | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30777897 | Background | 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. | |
| 28233803 | Background |
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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.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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 | 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) |
| 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |