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Developing a Diagnostic Tool to Predict Response to Chemotherapy

NCT04277195 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4750

Last updated 2020-02-20

No results posted yet for this study

Summary

Every year nearly 62,000 people are diagnosed with breast cancer in the UK. One in eight women in the UK will develop breast cancer in their lifetime.

The investigators are developing an inexpensive test to accurately predict how breast cancer patients will respond to the standard chemotherapy Anthracycline (AC). Only 15-20% of patients have no tumour remaining following AC, so a method of treatment selection is urgently needed.

Breast cancers are currently treated with a combination of chemotherapy, targeted therapy and surgery. However, breast cancers are not identical; each tumour's individual characteristics affect how they respond to treatment. Recently the investigators discovered a new tumour characteristic, a protein which is unusually active in approximately 20% of breast cancers. It was found that a patient whose tumour showed high activity often respond well to AC, and vice versa.

AC is an aggressive treatment which can potentially cause severe side effects, including a risk of permanent heart damage. It is important, therefore, to spare those patients who will not benefit from AC the physical and emotional side-effects of this drug. Currently, there is no predictive test for selecting which patients will benefit from AC and which will not. The investigators have shown that an accurate prediction can be made by testing the activity of a protein called 'SPerm associated AntiGen 5' (SPAG5) in tumour tissue.

The aim is to develop a clinical SPAG5 testing kit that can be used by hospital laboratories to determine the activity of SPAG5 in the tumour. This information will help guide the choice of treatment and achieve better patient outcomes.

In June 2018 the investigators started a three year National Institute for Health Research (NIHR) funded project to develop a lab test that could form the basis of a SPAG5 testing kit.

Conditions

Interventions

DIAGNOSTIC_TEST

SPAG5 Assay

Testing for SPAG5 expression in the tumour.

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER

  • Nottingham Trent University

    collaborator OTHER

  • University of Lincoln

    collaborator OTHER

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04277195 on ClinicalTrials.gov