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
Verified date | July 2020 |
Source | The Leeds Teaching Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Suspended |
Enrollment | 4000 |
Est. completion date | February 11, 2023 |
Est. primary completion date | February 11, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Age > or = 18 years old. - Males and females referred from primary care for possible breast cancer diagnosis. - Informed consent to provide a single blood collection for analysis Exclusion Criteria: - Age < 18 years old. - Informed consent to provide a single blood collection for analysis not given |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leeds Teaching Hospital NHS Trust | Leeds |
Lead Sponsor | Collaborator |
---|---|
The Leeds Teaching Hospitals NHS Trust | Innovate UK, PinPoint Data Science Ltd. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Outcome | Positive diagnosis of cancer (as diagnosed by the TWW referral) | 3 years | |
Secondary | Secondary Outcome | Positive outcome of non-cancer disease | 3 years | |
Secondary | Secondary Outcome | Positive diagnosis with an interval cancer, despite being given the all-clear by their TWW referral | 3 years |
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