Title

Cost-effective multi-cancer early detection by measuring patient plasma amino acid cross sections with the Enlighten test.

Description

Cancer remains the leading cause of death in the UK. If found earlier there are more treatment options and patients are more likely to survive 5 years post diagnosis. The Enlighten test has been?developed to quickly detect cancers as a measure of amino acid composition in the blood with results returnable within 48 hours from blood draw.

The primary aim of MODERNISED is to train and evaluate the Enlighten test in detecting 10 solid tumour cancer types where outcomes have been shown to be worse for people from deprived communities. The results from this trial will guide the design of a larger, randomised trial to generate evidence for evaluation as a diagnostic test as part of standard of care.

Objectives

Primary:

• Train and validate a machine learning algorithm (Enlighten) to predict current cancer status

Secondary:

• Train and validate Enlighten to predict cancer Tissue of Origin status among predicted cancer cases
• Train and validate Enlighten to predict cancer stage among predicted cancer cases

Tertiary:

• Monitor the proportion of participants in each quintile of the IMD in the recruitment region

Trial Design:

The NIHR funded MODERNISED study is a prospective, observational, multicenter study that aims to recruit 1350 individuals (1000 cancer cases and 350 symptomatic and asymptomatic cancer free controls) from 10 solid tumour cancer types (Bladder, Breast, Colorectal, Lung, Melanoma, Oesophageal, Ovarian, Pancreatic, Prostate, Renal). The study will collect a single 4mL blood sample which will be analysed at the Wessex Investigational Sciences Hub (WISH) laboratory.

Trial Status:

In set-up

Population:

1350 total participants comprised of 3 cohorts:

• 1,000 participants with confirmed diagnoses of bladder, breast, colorectal, lung, melanoma, oesophageal, pancreatic, prostate, or renal cancers
• 250 participants who present with cancer symptoms but are cancer free
• 100 participants who are asymptomatic cancer free healthy volunteers

Trial sites

Funder:

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 Ìì·¢ÓéÀÖÆåÅÆ_Ìì·¢ÓéÀÖAPP-¹ÙÍø|ÏÂÔØ Clinical Trials Unit and it is also supported by the Ìì·¢ÓéÀÖÆåÅÆ_Ìì·¢ÓéÀÖAPP-¹ÙÍø|ÏÂÔØ Experimental Cancer Medicine Centre.?