Project detail
Please find more information about each stream below.
The SAGITTARIUS clinical trial
The aim of the SAGITTARIUS study is to assess whether the proposed personalisation of patient post-surgical care is superior or at least equally effective, but with fewer side effects, compared to the conventional treatment pathway.
The SAGITTARIUS trial is a randomized clinical trial comparing the current one-size-fits-all standard of care treatment (chemotherapy with CAPOX or FOLFOX), to a personalized care approach based on the result of the liquid biopsy.
Personalized care approaches in the trial will range from i) alternative chemotherapy regimens to CAPOX/FOLFOX, ii) targeted therapies, iii) immunotherapy, and iv) wait & see intensive follow-up. The type of care is guided by the absence, presence or persistence of minimal residual disease (MRD) detected within 4 weeks from surgery by liquid biopsy.
The effectiveness of liquid biopsy as a guide to decide treatment post-surgery will be measured via multiple outcomes. The primary efficacy outcome measurement of the trial is relapse-free survival (RFS). Other outcomes include safety, including discontinuation rates among treatments, and patient-reported outcome measures (PROMs) to assess quality of life. These results will be coupled with cost and outcome analysis to understand the cost impact or cost-savings of this approach for healthcare systems.
The SAGITTARIUS trial will recruit approximately 700 people with either high-risk stage II colon cancer or loco-regional stage III colon cancer across 25 centres in three countries (Italy, Germany and Spain).
Health economics
The health economic aspect of SAGITTARIUS will analyze the cost effectiveness of using liquid biopsy to decide post-surgical care in patients with either high-risk stage II colon cancer or loco-regional stage III colon cancer.
In theory, using the right treatment for the right patient at the right time will lead to more efficient use of essential health system resources and finances, with less resources wasted on unnecessary treatments. In addition, if the use of liquid biopsy leads to fewer patients relapsing or with disease progression, then this will also be associated with a significant reduction in costs.
The health economic analysis will assess the direct and indirect cost implications of incorporating liquid biopsy into clinical practice. By coupling this information with the clinical outcomes, SAGITTARIUS will be able to estimate whether this approach provides good value for money for national healthcare systems.
Alongside direct healthcare costs, SAGITTARIUS will collect data on the broader societal costs associated with colon cancer, including impact on productivity and carers.
Ultimately, it is hoped that the health economic evaluation of SAGITTARIUS might enable the implementation of more cost-effective treatment approaches in everyday medical practice.
Quality of Life
In theory, using the right treatment for the right patient at the right time will lead to more effective therapy, better outcomes, and reduced unnecessary side effects – all of which should contribute to a better quality of life.
Quality of Life (QoL) data will be obtained via PROMS (patient-reported outcome measures), in order to fully understand the impact of this approach on patients' health and sense of wellbeing.
SAGITTARIUS will utilize the most widely-used questionnaire for estimating health-related quality of life (EQ-5D), along with cancer-specific questionnaires (the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-Colorectal (FACT-C), both including a colon cancer-specific section.
-Omics*
A multi-omics analysis to reveal the biological processes that will help us to answer questions around why biologically some tumours are different to others and why some are more likely to result in MMRD after surgery.
Analyses will include RNA sequencing and single-cell omics to understand exactly what is happening at the level of the interaction between the tumour and the tumour microenvironment.