Breast CancerENSEMBLENCT03880097
Enabling the Study of Metabolism in Breast Cancer Through Collection of Fresh-tissue Biopsies
An observational study of Breast Cancer, run by University College, London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Research Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women over the age of 18 with a new diagnosis of breast cancer.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read the detailed description
Comprehensive analysis linking breast tumour subtypes and their genetic profile with tumour metabolism are required. Traditional model systems are inadequate for this purpose.
- In vitro models do not represent a true tumour environment and are a subject of prolonged adaptation to artificial cell culture conditions.
- There is a need for in vivo and ex vivo models representing breast cancer diversity and tumour environment that can be used for predicting and testing the personalised therapies.
Metabolic analysis of fresh tissues (by metabolomics and Mass Spectrometry Imaging (MSI)) and tissues grown as patient derived xenograft models in vivo should reveal the unperturbed relationships between genetic profiles of tumour cells, tumour microenvironment and metabolic profiles of tumours. These relationships should provide new targets for metabolism-based therapies. The experimental systems required to perform this research require fresh breast cancer biopsies.
ENSEMBLE is a prospective multi-centre cohort study that aims to address these issues. Fresh breast tumour tissue will be collected from consented female participants diagnosed with invasive breast cancer, for translational research. Up to 240 participants will be enrolled over a 36-month period and clinical follow-up data will be collected for up to 5 years. Study participants will undergo a "research biopsy" (core biopsy) for translational research that aims to collect up to four cores. The procedure is the same as the standard of care percutaneous core needle biopsy that the patient will have to inform their diagnosis, however, as it is an additional procedure, it is called a "research biopsy". Wherever possible biopsy samples will be taken from the operative specimen at the time of primary surgery however, where neo-adjuvant therapy is planned in a patient's care plan, these patients will undergo a research percutaneous biopsy prior to their surgery, performed either using image-guidance or as a clinical biopsy.
Collected tumour material will be divided: a portion will immediately be frozen in liquid nitrogen, and a portion will be kept fresh. The material will be transported to the primary receiving laboratory at the Francis Crick Institute where part of the sample will be immediately engrafted into immune-deficient mice to create a patient-derived xenograft (PDX) model. The remaining primary samples and samples from PDXs will be used for genomic, metabolomic and other biochemical analyses.
Information about participant demographics, medical history and tumour characteristics will be collected at registration. Participants may be followed up for up to 5 years for clinical outcome data and to clarify information about medical history
- Conditions
- Breast Cancer
- Being tested
- Research Biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research BiopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Research Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of biopsies collected
The primary outcome is the number of biopsies successfully collected from the 240 women approached.
Measured: 3 years
Secondary outcomes (2)
Breast cancer cell biology
Understanding how specific, pro-tumorigenic events change breast cancer cell metabolism.
Measured: 5 years
Identifying vulnerabilities in breast cancer cell metabolism
Identifying vulnerabilities in cancer cell metabolism with a view to identification of novel therapeutic targets.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neill Patani, MD, Principal investigator, University College London HospitalsJayant Vaidya, MD, Principal investigator, The Whittington HospitalMichael Douek, MD, Principal investigator, Guy's and St Thomas' NHS Foundation TrustAmna Sherri, MD, Principal investigator, Royal Free London NHS Foundation TrustLaura Johnson, MD, Principal investigator, Barts & The London NHS TrustRobert Price, MD, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880097
- Sponsor's protocol ID
- 17/0765
- Acronym
- ENSEMBLE
- Status last verified
- Mar 2019
- First submitted
- 9 Oct 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To follow.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling the Study of Metabolism in Breast Cancer Through Collection of Fresh-tissue Biopsies
- ClinicalTrials.gov ID
- NCT03880097
- Acronym / sponsor ID
- ENSEMBLE / 17/0765
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Comprehensive analysis linking breast tumour subtypes and their genetic profile with tumour metabolism are required. Traditional model systems are inadequate for this purpose.
- In vitro models do not represent a true tumour environment and are a subject of prolonged adaptation to artificial cell culture conditions.
- There is a need for in vivo and ex vivo models representing breast cancer diversity and tumour environment that can be used for predicting and testing the personalised therapies.
Metabolic analysis of fresh tissues (by metabolomics and Mass Spectrometry Imaging (MSI)) and tissues grown as patient derived xenograft models in vivo should reveal the unperturbed relationships between genetic profiles of tumour cells, tumour microenvironment and metabolic profiles of tumours. These relationships should provide new targets for metabolism-based therapies. The experimental systems required to perform this research require fresh breast cancer biopsies.
ENSEMBLE is a prospective multi-centre cohort study that aims to address these issues. Fresh breast tumour tissue will be collected from consented female participants diagnosed with invasive breast cancer, for translational research. Up to 240 participants will be enrolled over a 36-month period and clinical follow-up data will be collected for up to 5 years. Study participants will undergo a "research biopsy" (core biopsy) for translational research that aims to collect up to four cores. The procedure is the same as the standard of care percutaneous core needle biopsy that the patient will have to inform their diagnosis, however, as it is an additional procedure, it is called a "research biopsy". Wherever possible biopsy samples will be taken from the operative specimen at the time of primary surgery however, where neo-adjuvant therapy is planned in a patient's care plan, these patients will undergo a research percutaneous biopsy prior to their surgery, performed either using image-guidance or as a clinical biopsy.
Collected tumour material will be divided: a portion will immediately be frozen in liquid nitrogen, and a portion will be kept fresh. The material will be transported to the primary receiving laboratory at the Francis Crick Institute where part of the sample will be immediately engrafted into immune-deficient mice to create a patient-derived xenograft (PDX) model. The remaining primary samples and samples from PDXs will be used for genomic, metabolomic and other biochemical analyses.
Information about participant demographics, medical history and tumour characteristics will be collected at registration. Participants may be followed up for up to 5 years for clinical outcome data and to clarify information about medical history
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research Biopsy | – | Procedure: Research BiopsyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women over the age of 18 with a new diagnosis of breast cancer.
Key inclusion criteria (6 listed)
- Histological diagnosis of newly diagnosed breast cancer
- Known ER and HER2 receptor status
- Tumour diameter ≥1cm on imaging
- Female
- Age 18 or above
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research BiopsyThe "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. | Procedure or surgery | Research Biopsy |
Primary outcome
Number of biopsies collected
Time frame: 3 years
The primary outcome is the number of biopsies successfully collected from the 240 women approached.
2 secondary outcomes
Breast cancer cell biology
Time frame: 5 years
Identifying vulnerabilities in breast cancer cell metabolism
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: Undecided. To follow.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neill Patani, MD principal investigator
University College London Hospitals
Jayant Vaidya, MD principal investigator
The Whittington Hospital
Michael Douek, MD principal investigator
Guy's and St Thomas' NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danni Maas (0207 679 9280, situ.ensemble@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of biopsies collected (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.