Enabling the Study of Metabolism in Breast Cancer Through Collection of Fresh-tissue Biopsies
ENSEMBLE
1 other identifier
observational
240
0 countries
N/A
Brief Summary
This study aims to evaluate how breast cancer cells metabolise nutrients in order to grow. Patients enrolled into this study will undergo a research biopsy that will aim to collect up to 4 cores of tumour tissue. These tissues will then be used in translational research to analyse how specific pro-tumorigenic events change breast cancer cell metabolism (compared to healthy cell metabolism).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2018
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
ExpectedMarch 19, 2019
March 1, 2019
2.9 years
October 9, 2018
March 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of biopsies collected
The primary outcome is the number of biopsies successfully collected from the 240 women approached.
3 years
Secondary Outcomes (2)
Breast cancer cell biology
5 years
Identifying vulnerabilities in breast cancer cell metabolism
5 years
Study Arms (1)
Research Biopsy
The research biopsy is the same procedure as a standard of care percutaneous biopsy. A "core" (hollow) needle is inserted into the tumour tissue in order to collect tissue samples. The procedure is called a research biopsy as it is an additional procedure to the standard of care, used purely to collect tissue samples for research purposes.
Interventions
The "Research Biopsy" is a biopsy in addition to the standard of care biopsies that the patient will have to inform their diagnosis. The actual procedure is not any different to the standard per-cutaneous biopsy, this is just an additional procedure, solely for research purposes.
Eligibility Criteria
Women over the age of 18 with a new diagnosis of breast cancer.
You may qualify if:
- Histological diagnosis of newly diagnosed breast cancer
- Known ER and HER2 receptor status
- Tumour diameter ≥1cm on imaging
- Female
- Age 18 or above
- Written informed consent
You may not qualify if:
- Previously treated invasive breast cancer
- Primary systemic therapy for breast cancer prior to biopsy
- Oestrogen replacement therapy (HRT) within 14 days of biopsy in ER-positive tumours
- Pregnancy or breastfeeding
- Not considered suitable by clinical team
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neill Patani, MD
University College London Hospitals
- PRINCIPAL INVESTIGATOR
Jayant Vaidya, MD
The Whittington Hospital
- PRINCIPAL INVESTIGATOR
Michael Douek, MD
Guy's and St Thomas' NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Amna Sherri, MD
Royal Free London NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Laura Johnson, MD
Barts & The London NHS Trust
- PRINCIPAL INVESTIGATOR
Robert Price, MD
King's College Hospital NHS Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2018
First Posted
March 19, 2019
Study Start
April 1, 2019
Primary Completion
February 28, 2022
Study Completion (Estimated)
February 28, 2027
Last Updated
March 19, 2019
Record last verified: 2019-03