At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Non-Interventional Study (other)
- How long the study runs
- Study runs about 61 months (dates as stated)
- About the drug or intervention
- Non-Interventional Study — other: First nodule detection CT scans as per eligibility criteria will be used as input into in-house software to extract multiple radiomic features and used to develop a machine learning based classifier to differentiate nodule aetiology.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by the Royal Marsden NHS Foundation Trust, is looking at whether artificial intelligence (AI) and computer analysis of CT (computed tomography) scans can help sort lung nodules into groups in people who have already been cured of another solid cancer. It covers people with indeterminate pulmonary nodules, lung metastases, second primary cancer, and lung cancer. The aim is to improve how these nodules are understood after cancer treatment.
Who can take part
- You had a solid organ cancer treated with the aim of cure within the last 10 years, for example by surgery, radiotherapy, chemotherapy, or a combination, and the cancer went away or into remission
- A new lung nodule of at least 5mm was found on a recent CT scan of your chest
- What the nodule actually is (benign or cancer) is already known, from scans showing stability over 2 years, or from biopsy results, or from scans showing growth agreed by the medical team
- Your CT scan used slices of 2.5mm thickness or thinner
Who may not be able to
- Your CT scan is more than 10 years old
- You have a non-solid blood cancer such as leukaemia
- Your first cancer came back as a small number of spread spots (oligometastatic recurrence) that were then treated with the aim of cure
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,000
- Started
- 2021-10-13
- Last checked
- 2022-05
Plain English Summary
What is this study?
- • Testing a new treatment for indeterminate pulmonary nodules
- • Clinical study - 1,000 participants
- • This study will assess the utility of radiomics and artificial intelligence approaches to new lung nodules in patients who have undergone radical treatment for a previous cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with indeterminate pulmonary nodules
Where?
- • London - The Royal Marsden NHS Foundation Trust (Chelsea Site)
- • London - Royal Brompton Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will assess the utility of radiomics and artificial intelligence approaches to new lung nodules in patients who have undergone radical treatment for a previous cancer.
More detail
Improvements in cancer detection and diagnosis have led to increasing numbers of patients being diagnosed with early stage cancer and potentially receiving curative therapy with improved survival outcomes. Recent retrospective studies in cancer survivors have demonstrated such patients possess an increased risk of further cancer in their lifetime compared to the general population, in part potentially due to shared lifestyle risk factors (e.g. smoking), genetic cancer pre-disposition or downstream oncogenic side effects of anti-cancer therapies (eg. radiotherapy). Lung cancer remains the leading cause of cancer related deaths worldwide and the lungs also represent a common site for metastatic disease in patients with non-pulmonary malignancy. Furthermore, lung cancer is one of the most common second primary malignancy in patients with a prior history of treated cancer. Therefore, discerning the significance of a pulmonary nodule in the context of a previous cancer remains a clinical challenge given it may possess the potential to represent benign disease, metastatic relapse or new primary malignancy. This study will assess the utility of radiomics and artificial intelligence approaches to new lung nodules in patients who have undergone radical treatment for a previous cancer. This will entail use of machine learning (ML) approaches and later, exploration of deep-learning/convolutional neural network approaches to nodule interpretation for differentiation of benign, metastatic and new primary lung cancer nodules/lesions. Development of a ML classifier or deep learning based tool may help guide which patients would benefit from earlier investigations including additional imaging, biopsy sampling and lead to earlier cancer diagnosis, leading to better patient outcomes in this unique cohort. This is a retrospective study analysing data already collected routinely as part of patient care. All data will be anonymised prior to any analysis, no patient directed/related interventions will be employed and consent-waiver for study inclusion will be exercised.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Confirmed history of previous radically or curative-intent treated solid organ cancer within 10 years of new index...
- ✓Biopsy confirming previous cancer with MDT consensus and successful cancer resolution/remission following...
- ✓Radical treatment for previous cancer defined as either of the following:
- ✓Surgical resection
- ✓Radical radiotherapy or stereotactic beam radiotherapy
Who cannot take part
- ✗CT Imaging \> 10 years old
- ✗Non-solid haematological malignancies including leukaemia
- ✗Cases of radically treated primary cancer disease with early oligometastatic recurrence treated radically
See the full criteria
Where Is This Study? (2 UK sites)
The Royal Marsden NHS Foundation Trust (Chelsea Site)
London SW3 6JJ, United Kingdom
Royal Brompton Hospital
London SW3 6NP, United Kingdom
How to Get in Touch
Sejal Jain
Sponsor contactCONTACT
Laura Boddy
Sponsor contactCONTACT
