Guide for Prioritisation of Patients for Referral to Breast Clinics

NCT04474652 | Suspended

• 1 other identifier: RD19/125787
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Positive diagnosis of cancer (as diagnosed by the TWW referral)

  3 years

Secondary Outcomes (2)

• Secondary Outcome

  3 years

• Secondary Outcome

  3 years

Interventions

Single Blood Draw from each participant OTHER

Health Professionals will seek informed consent and take a single blood collection from the participant. This will take place during the patient's visit to the breast one stop clinic as part of their routine urgent breast referral pathway.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A cohort of patients (4000) that have been referred from primary care (via their GP) for possible breast cancer diagnosis in the Leeds area. These patients will be on a Two Week Wait (TWW) pathway. Note: The TWW pathway constitutes part of the urgent cancer referral pathway.

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years old.
• Informed consent to provide a single blood collection for analysis not given

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead
• Innovate UK: collaborator
• PinPoint Data Science Ltd.: collaborator

Study Sites (1)

Leeds Teaching Hospital NHS Trust

Leeds, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will be collecting a single blood collection from patients who have been referred in to the breast LTHT clinic via the 'urgent cancer referral pathway' to have tests performed through NHS blood sciences laboratories. These samples will be processed into serum and plasma (i.e. not covered by the Human Tissues Act).

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: July 17, 2020
• Study Start: February 12, 2020
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2023
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

GB (1)