Guide for Prioritisation of Patients for Referral to Breast Clinics

July 13, 2020 updated by: The Leeds Teaching Hospitals NHS Trust

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom
        • Leeds Teaching Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: 3 years
Positive diagnosis of cancer (as diagnosed by the TWW referral)
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Outcome
Time Frame: 3 years
Positive outcome of non-cancer disease
3 years
Secondary Outcome
Time Frame: 3 years
Positive diagnosis with an interval cancer, despite being given the all-clear by their TWW referral
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Leeds Teaching Hospitals NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Innovate UK
PinPoint Data Science Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RD19/125787

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Single Blood Draw from each participant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings