Enabling the Study of Metabolism in Breast Cancer Through Collection of Fresh-tissue Biopsies (ENSEMBLE)
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|ClinicalTrials.gov Identifier: NCT03880097|
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment|
|Breast Cancer||Procedure: Research Biopsy|
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 Type :||Observational|
|Estimated Enrollment :||240 participants|
|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|
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.
- Number of biopsies collected [ Time Frame: 3 years ]The primary outcome is the number of biopsies successfully collected from the 240 women approached.
- Breast cancer cell biology [ Time Frame: 5 years ]Understanding how specific, pro-tumorigenic events change breast cancer cell metabolism.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880097
|Contact: Danni Maas||0207 679 firstname.lastname@example.org|
|Contact: Mariia Yuneva, PhD||020 3796 1651 ext PhDemail@example.com|
|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|