Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
ctDNA detection rate within different cancer types (and overall) |
The primary endpoint, ctDNA detection rate, overall and within different cancer types will be presented as a proportion of patients with a positive ctDNA test out of those tested, with 90% confidence intervals |
Throughout study completion, up to one year |
|
Primary |
PREVAIL ctDNA Part 2 Study |
Primary end point, Proportion of patients with detectable ctDNA which supports a diagnosis of malignancy and commence treatment |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
Proportion of patients with a positive ctDNA result which identified a diagnosis and/or commenced treatment |
All secondary endpoints will be analysed in the patients diagnosed with suspected cancer, i.e. positive ctDNA result, unless stated. They will also be presented overall and by cancer type. The proportion of patients with positive ctDNA result which identified a diagnosis and/or commenced treatment will be presented as a proportion with 90% confidence intervals |
Throughout study completion, up to one year |
|
Secondary |
Proportion of patients with a positive ctDNA result which assisted in prioritising invasive diagnostic tests |
Proportion of patients with positive ctDNA result which assisted in prioritising invasive diagnostic tests will be presented as a proportion with 90% confidence intervals |
Throughout study completion, up to one year |
|
Secondary |
The association of ctDNA result (positive versus negative) and the PREVAIL-imaging pathway scoring result |
The association between ctDNA result (positive versus negative) and the PREVAIL-imaging pathway scoring result will be assessed descriptively by presenting cross-tabulations and relevant proportions |
Throughout study completion, up to one year |
|
Secondary |
Estimation of the cost of liquid biopsy in lieu of tissue biopsy as compared to standard of care investigations and treatments prioritisation |
Simple estimation of the cost of liquid biopsy in lieu of tissue biopsy as compared to standard of care investigations and treatments prioritisation will be performed |
Throughout study completion, up to one year |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 1a |
Treatment response objective response rate |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 1b |
Progression free survival |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 1c |
Overall survival |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 2 |
Proportion of patients who undergo a repeated invasive procedure |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 3a- comparison with NHS targets |
Comparison of diagnostic pathway duration with NHS faster Diagnostic Standard (FDS) |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 3b- comparison with NHS targets |
Comparison of diagnostic pathway duration with 62 day wait target |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 4a |
Type of complications from invasive diagnostic procedures |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 4b |
Frequency of complications from invasive diagnostic procedures |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 4c |
Severity of complications from invasive diagnostic procedures |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 5 |
Number and type of invasive procedures performed |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 5b |
Number of histopathology reviews |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 5c |
Number of tissue based NGS performed |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 6a |
Healthcare costs associated with diagnostic pathway |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 6b |
Cost per-quality adjusted-life-year of diagnostic pathway |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 6c |
Number of hospital visits in diagnostic pathway |
To run parallel for 12 months alongside the ACCESS implementation programme |
|
Secondary |
PREVAIL ctDNA Part 2 Study secondary end point 6d |
Length of hospital stay during diagnostic pathway |
To run parallel for 12 months alongside the ACCESS implementation programme |
|