Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enabling the Study of Metabolism in Breast Cancer Through Collection of Fresh-tissue Biopsies (ENSEMBLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880097
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
University College, London

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).

Condition or disease Intervention/treatment
Breast Cancer Procedure: Research Biopsy

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.

  1. In vitro models do not represent a true tumour environment and are a subject of prolonged adaptation to artificial cell culture conditions.
  2. 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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enabling the Study of Metabolism in Breast Cancer Through Collection of Fresh-tissue Biopsies
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Procedure: Research Biopsy
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.




Primary Outcome Measures :
  1. Number of biopsies collected [ Time Frame: 3 years ]
    The primary outcome is the number of biopsies successfully collected from the 240 women approached.


Secondary Outcome Measures :
  1. Breast cancer cell biology [ Time Frame: 5 years ]
    Understanding how specific, pro-tumorigenic events change breast cancer cell metabolism.

  2. Identifying vulnerabilities in breast cancer cell metabolism [ Time Frame: 5 years ]
    Identifying vulnerabilities in cancer cell metabolism with a view to identification of novel therapeutic targets.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women over the age of 18 with a new diagnosis of breast cancer.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880097


Contacts
Layout table for location contacts
Contact: Danni Maas 0207 679 9280 situ.ensemble@ucl.ac.uk
Contact: Mariia Yuneva, PhD 020 3796 1651 ext PhD mariia.yuneva@crick.ac.uk

Sponsors and Collaborators
University College, London
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03880097    
Other Study ID Numbers: 17/0765
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To follow.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases