Investigating the enlighten multi-cancer early detection test
| ISRCTN | ISRCTN17299125 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17299125 |
| IRAS number | 338326 |
| Secondary identifying numbers | CPMS 60138 |
- Submission date
- 28/01/2025
- Registration date
- 05/02/2025
- Last edited
- 30/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Cancer remains the leading cause of death in the UK. If found at its earliest stage, patients are 5-10 times more likely to survive their diagnosis for 5 years, highlighting the importance of developing new early detection methods for cancer to increase patient survival rates, provide greater treatment options and reduce strain on the NHS. MODERNISED aims to evaluate a new type of multi-cancer early detection test called EnlightenTM. Unlike other recently developed early cancer detection tests that focus on measuring signals released by tumours, the EnlightenTM test measures the host immune response to tumour development.
Who can participate?
Patients diagnosed with or symptomatic of bladder cancer, breast cancer, colorectal cancer, lung cancer, melanoma cancer, oesophageal cancer, ovarian cancer, pancreatic cancer, prostate cancer and renal cancer. Healthy volunteers who are registered to the Southampton CRF Healthy Volunteer register.
What does the study involve?
The study will collect a single 4 mL blood sample from 1000 cancer patients and 350 controls. The plasma sample will be analysed using the new developmental test, in the context of the deidentified clinical data.
What are the possible benefits and risks of participating?
This is an observational study and participants will not receive any information on their sample's test results, however, this study will help researchers better understand the EnlightenTM test and may help aid future implementations for the early detection of cancer. There is a minor risk of patient injury (e.g., bruising) during the blood draw.
Where is the study run from?
University of Southampton Clinical Trials Unit (SCTU) (UK)
When is the study starting and how long is it expected to run for?
August 2024 to July 2026
Who is funding the study?
This trial is primarily funded by the National Institute for Health and Care Research (NIHR) in partnership with the Office of Life Sciences (OLS). The study has additional financial support from Cancer Research UK core funding at the Southampton Clinical Trials Unit and it is also supported by the Southampton Experimental Cancer Medicine Centre.
Who is the main contact?
Hannah Warming, modernised@soton.ac.uk
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-a-new-blood-test-to-find-cancer-early-modernised
Contact information
Public
Southampton Clinical Trials Unit (University of Southampton)
Mailpoint 131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 8059 9536 |
|---|---|
| Modernised@soton.ac.uk |
Scientific, Principal Investigator
Somers Cancer Research Building
Southampton General Hospital (Mailpoint 824)
Southampton
S016 6YD
United Kingdom
 ORCID ID |
0000-0002-7517-6938 |
|---|---|
| Phone | +44 (0)23 8059 8942 |
| A.davies@southampton.ac.uk |
Study information
| Study design | Prospective observational case-control multicentre study with longitudinal follow-up for controls to monitor for cancer diagnosis |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Cost-effective multi-cancer early detection by measuring patient plasma amino acid cross sections with the Enlighten test |
| Study acronym | MODERNISED |
| Study objectives | Improving early diagnosis is a priority for cancer researchers and the NHS. Currently, there are four screening programmes in the UK, for bowel, breast, cervical and lung cancer and screening is only for one cancer at a time. The MODERNISED trial will evaluate whether the ENLIGHTEN test, developed by biotech company Proteotype Diagnostics, can predict if a patient has one of 10 cancer types using a blood sample. Unlike most current research into multi-cancer blood tests focussed on detecting abnormal DNA that has been released into the bloodstream, ENLIGHTEN looks at levels of certain proteins which are released by the body’s immune system in response to the cancer. The trial will recruit 1000 cancer patients as well as 350 control samples from symptomatic and healthy volunteers. The trial will open at 5 centres in the south of England. |
| Ethics approval(s) |
Approved 04/12/2024, West Midlands – Edgbaston (2 Redman Place, Stratford, E20 1JQ, United Kingdom; +44 (0)207 104 8155; edgbaston.rec@hra.nhs.uk), ref: 24/WM/0234 |
| Health condition(s) or problem(s) studied | Bladder cancer, breast cancer, colorectal cancer, lung cancer, melanoma cancer, oesophageal cancer, ovarian cancer, pancreatic cancer, prostate cancer and renal cancer |
| Intervention | This is a prospective, observational, case-control study for the collection of blood for the training and evaluation of the EnlightenTM Multi-Cancer Early Detection test. The test is comprised of two parts: Part 1 is the Enlighten assay which quantifies amino acid cross-sections from neat blood plasma and Part 2 is the Enlighten algorithm, machine machine-learning process that analyses the assay results to predict a patient's cancer status, cancer tissue of origin and cancer stage. Blood samples will be collected from 1000 patients recently diagnosed with bladder cancer, breast cancer, colorectal cancer, lung cancer, melanoma cancer, oesophageal cancer, ovarian cancer, pancreatic cancer, prostate cancer and renal cancer. These patients will be identified through the participating site's oncology clinics, and blood will be taken before treatment. Samples will also be collected from 250 symptomatic cancer-free controls, identified through urgent cancer referral pathways and 100 asymptomatic cancer-free controls identified through the University Hospital Southampton NHS Foundation Trust's Healthy Volunteer Register. Clinical and demographic data will be collected during the patient's blood collection appointment, along with an additional follow-up data collection time point after 3 months. This follow-up data collection time point is used to confirm the patient's cancer status and staging. The patient's blood sample and clinical data will be used to develop and evaluate the Enlighten algorithm. Patients will be randomised into algorithm development and held-out sets in a ratio of 3:1, balanced by cancer site, to ensure that there is a balance between how the model is being developed and evaluated. |
| Intervention type | Other |
| Primary outcome measure | Cancer status (presence versus absence of cancer) measured by a cancer diagnosis being present in routine NHS diagnostic records by the end of follow-up |
| Secondary outcome measures | 1. Tissue of Origin (1 of 10 solid tumour cancers) measured using the stated Tissue of Origin for the first cancer diagnosis present in routine NHS diagnostic records by the end of follow-up. 2. Cancer stage (stage I/II/III/IV) measured using the stated cancer stage for the first cancer diagnosis present in routine NHS diagnostic records by the end of follow-up. |
| Overall study start date | 01/08/2024 |
| Completion date | 31/07/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1350 |
| Key inclusion criteria | 1. Age 18 years or older 2. Able to provide a written informed consent 3. Willing to provide 4 mL blood sample at the time of enrolment |
| Key exclusion criteria | All Participants: 1. Pregnancy (by self-report of pregnancy status), or pregnancy within the last 12 months 2. Current febrile illness 3. Infection requiring hospitalisation within 30 days prior to blood draw 4. Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw. 5. Undergone a surgical procedure (including diagnostic biopsy) within 30 days prior to blood draw 6. Undergone a blood transfusion within 30 days prior to blood draw 7. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant 8. Poor health status or unfit to tolerate blood draw Confirmed Cancer Cohort: 9. Currently receiving, or ever received, any of the following therapies to treat their current cancer: surgical management of the cancer beyond that required to establish the cancer diagnosis; local, regional or systemic chemotherapy including chemoembolization; targeted therapy, immunotherapy including cancer vaccines; hormone therapy; or radiation therapy 10. Known prior diagnosis of cancer, per guidance in protocol, separate from the confirmed or suspected cancer diagnosis associated with study enrolment. Exception: subjects with history of non-melanoma skin cancer (e.g., BCC or SCC) that has been effectively and exclusively managed by local or focal therapies such as surgical resection, radiation therapy, cryotherapy or topical therapy, are eligible to enrol. 11. Cancer recurrence 12. Synchronous malignancies Symptomatic and Asymptomatic Cancer-Free Cohort: 13. Known current or prior diagnosis of cancer, per guidance in protocol. Exception: subjects with history of non-melanoma skin cancer (e.g., BCC or SCC) that has been effectively and exclusively managed by local or focal therapies such as surgical resection, radiation therapy, cryotherapy or topical therapy, are eligible to enrol. 14. Oral or IV corticosteroid use in past 14 days prior to blood draw |
| Date of first enrolment | 23/01/2025 |
| Date of final enrolment | 31/07/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom
Williams Avenue
Dorchester
DT1 2JY
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Department – Central Office
University Hospital Southampton NHS Foundation Trust
Ground Floor, Duthie Building
MP138, Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Phone | +44-(0)23-8120 5213 |
|---|---|
| sponsor@uhs.nhs.uk | |
| Website | https://www.uhs.nhs.uk/ |
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results will be presented at scientific meetings and published in international peer-reviewed journals. Lay summaries of study progress and findings will be published on Southampton Clinical Trial Unit’s website. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the Southampton Clinical Trials Unit Data Sharing Release Committee (sctu@soton.ac.uk). SCTU is committed to the responsible sharing of clinical study data and samples with the wider research community. Data access is administered through the SCTU Data Release Committee, who will consider requests once the final analysis has been published. |
Editorial Notes
30/05/2025: Cancer Research UK plain English summary link added.
23/05/2025: The following changes were made to the trial record:
1. The study website was updated.
2. The study participating centre Oxford University Hospitals NHS Foundation Trust was removed.
28/01/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
