Breast Cancer Clinical Trial
Official title:
Development of a Decision Support Tool for Ruling Out Cancer in Patients Referred From Primary Care for Possible Breast Cancer Diagnosis
GPs in primary care in England currently refer over 2.17 million patients per year with vague
symptoms to the urgent cancer referral pathway. While this catches over 150,000 cancer cases
each year, 93% of the referred patients do not have cancer. For breast cancer, GPs refer
343,000 cases per year. Each of these patients are referred to a one stop clinic for
diagnosis. The Leeds teaching Hospitals' Trusts' Breast Unit, receives 10,000 per year, with
only 5% of patients actually being diagnosed with cancer.
The breast cancer pathway involves a triple assessment process, which includes a clinical
examination, imaging (mammogram or ultrasound) and possibly a biopsy test. It is a
particularly expensive process as it is an imagingintense pathway; this places considerable
strain on NHS diagnostic facilities. Small changes will not be enough to solve this problem -
a new approach is needed. The purpose of this study is to see if we can develop a blood test
that can support doctors in identifying patients for whom the likelihood of having breast
cancer is extremely low. This would avoid unnecessary referral for those patients to the one
stop clinic. Patients with higher chances of suspected breast cancer would be referred to the
one stop clinic in the usual way.
Key to the idea of safely "ruling-out" patients is that the test must not miss patients who
do have cancer. By measuring a broad range of indicators (markers) in blood, the test will
provide a more accurate picture of the underlying biology. The test is also being developed
within the NHS, so that it can be adopted quickly into NHS computer systems and laboratories
to maximise patient benefit, whilst being held to the NHS's high standards for clinical
evidence and value.
Following on from the service evaluation of retrospective TWW cases within The Leeds Teaching
Hospitals Trust (between 2011-2018), the aim is to undertake a prospective analysis of a
cohort of patients (4000) that have been referred from primary care (via their GP) for
possible breast cancer diagnosis in the Leeds area. The analysis will include de-identified
routine clinical data and blood tests from patients on the primary care referral cancer
diagnosis pathway for cancer risk assessment.
This is intended as a non-interventional study, where results from this study will not
influence patient care.
The study includes 3 phases/workstreams:
1. Validate previously developed prototype algorithm (computer instructions)
2. Update algorithm incorporating additional blood biomarkers and other relevant clinical
data
3. Validate diagnostic accuracy of updated algorithm The study will include 4000 patients
on TWW pathways. Note: The TWW pathway constitutes part of the urgent cancer referral
pathway. This study aims to address a major unmet clinical need for breast cancer
services within the NHS by safely combining the wealth of routinely collected clinical
data and testing of blood samples within the NHS, with secure IT infrastructure in the
NHS and the University of Leeds, to efficiently develop a risk assessment tool (guide)
to rule-out cancer within a routine NHS environment.
Inclusion criteria are:
- Age ≥ 18 years old
- Male and female patient must have been referred from primary care for possible breast
cancer diagnosis
- Patient consented to have blood tests The data sets will be divided into a development
and validation data set (50:50 split). A range of statistical approaches will be
performed on the training data set. The algorithm parameters will then be 'locked down'
and validated on the remaining test data set. Performance will be assessed via ROC
(Receiver Operator Characteristic) curves, sensitivity and specificity,
Area-Under-Curve, negative/positive predictive values and diagnostic odds ratios. The
algorithm generation and data analysis will be conducted at the University of Leeds,
specifically within a secure VRE within the Leeds Institute for Data analytics (LIDA).
Particular scrutiny will be given to the test set patients most likely to be false
negatives in this analysis (i.e. those patients with cancer whose predicted probability
is very low). Key to further improvements in this approach will be to characterise this
sub-group and identify possible ways in which they might be identified by an improved
analysis in a future study. Eligible participants will be observed electronically for 2
years post blood testing to ensure any patients with undetected cancer, who develop
cancer within a year, are not missed. The study will end once the consented sample and
data retention periods have completed therefore the expected duration of project is 5
years.
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