Whole genome sequencing in high risk breast cancer patients

Not Applicable

Recruiting

• Conditions: breast cancer; Cancer - Breast

• Registration Number: ACTRN12621001285842
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-23
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients must be diagnosed with a breast cancer that will be treated via a neo-adjuvant pathway.

Exclusion Criteria

None

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The breast tissue core biopsy will be subjected to whole genome sequencing and a Variant report prepared [Core biopsy collection 1 week prior to initiation of neoadjuvant chemotherapy];normal DNA (from blood) will be subjected to whole genome sequencing and a Variant report prepared [Blood collection prior to initiation of neoadjuvant chemotherapy]; Circulating Tumour Cells will be purified from pre- and post- treatment blood samples and analysed.[Post-chemotherapy blood sample will be taken a week after therapy completion; analysis of circulating tumour cells will then be made]

Secondary Outcome Measures

Name	Time	Method
Following resection and standard diagnostic pathology assessment, any residual excess to diagnosis will be process for DNA extraction and sequenced.[At the completion of neo-adjuvant chemotherapy course, patient will undergo surgery (as standard of care); residual tumour excess to diagnostic requirement will be sequenced.]