Breast CancerNCT03430024
Nuclear Myosin VI - a Therapeutic Target in Breast Cancer
An observational study of Breast Cancer, run by Maidstone & Tunbridge Wells NHS Trust at 1 site in United Kingdom.
Trial summary
Gene expression, the transfer of the genetic code into cellular proteins is one of the most fundamental processes in living cells. This process is orchestrated by protein-based molecular machines, called RNA polymerases that read the DNA sequence to generate messenger RNA (mRNA), which is translated by the cellular… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Association of Myosin VI with oestrogen receptor
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 May 2019to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Tissue will be obtained from patients diagnosed with early invasive breast cancer undergoing primary surgery. We will enrol 100 women who have been newly diagnosed with T2 (>2cm) palpable invasive breast cancer having primary surgical treatment at Maidstone Hospital.
Who may be able to join
- Clinical diagnosis of early breast cancer
- Palpable tumour greater than 2cm
- Scheduled for primary surgical treatment
Who cannot join
- Locally advanced breast cancer
- Metastatic breast cancer
- Significant co-morbidities (ASA 4 or above)
- Past history of breast cancer
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Maidstone and Tunbridge Wells NHS Trust
Maidstone, Kent, ME16 9QQ
Karina Cox, FRCS MD, 00 44 1622 22 4111, karina.cox@nhs.net
About this study
Official title: Nuclear Myosin VI - a Therapeutic Target in Estrogen Receptor Positive Breast Cancer?
Gene expression, the transfer of the genetic code into cellular proteins is one of the most fundamental processes in living cells. This process is orchestrated by protein-based molecular machines, called RNA polymerases that read the DNA sequence to generate messenger RNA (mRNA), which is translated by the cellular machinery to make proteins. Our cells have evolved elaborate regulation mechanisms to control these molecular machines and a breakdown in this regulation leads to diseases such as cancer.
Recently, molecules called myosins have been discovered in the genetic storage compartment of the cell (the nucleus) where they interact with RNA polymerases to regulate protein production. This is interesting because myosins are usually found outside the nucleus transporting cellular cargo or generating muscle contraction. In breast cancer cells, myosin is abundant and interacts with the oestrogen receptor. The majority of breast cancer in the UK is oestrogen receptor positive and activation of this receptor is an important factor controlling the growth of cancer cells. Oestrogen receptor activation appears to be dependent upon myosin and this research project will investigate how myosins are targeted to specific genes and how they are themselves regulated. This will greatly enhance our understanding of the role of nuclear myosins in oestrogen receptor positive breast cancer and may identify a novel therapeutic target for future drug development.
Read the detailed description
Purpose and Design The primary aim of this project is to understand the significance of the newly discovered interaction between myosin VI (MVI) and the oestrogen receptor in breast cancer cells. The study will investigate the types of genes that MVI regulates and whether the sites of MVI - oestrogen receptor interactions (nucleus or cytoplasm) are important for the expression of oestrogen receptor targets. In breast cancer cells, oestrogen receptors can mutate to become permanently activated, leading to unrestrained tumour growth. Investigating the role of MVI in this metabolic scenario may reveal a potential therapeutic window for hormone refractory oestrogen receptor positive breast cancer.
In order to answer these questions, the methodology will use combination of experiments on established cell lines and patient samples.
The research proposal is a collaborative effort between Dr Chris Toseland (whose group has identified the link between MVI and the oestrogen receptor) at the University of Kent and the Breast Surgery, Pathology and Research and Development departments at Maidstone and Tunbridge Wells NHS Trust.
Recruitment Potential patients for recruitment will be identified at the weekly multi-disciplinary meeting following a diagnosis of primary breast cancer and a decision to proceed with surgery as the first treatment. The actual explanation of the study will take place during the first treatment planning consultation with the treating breast surgeon. The patient will be given written information about the study as well as a contact number of a research nurse/ breast care nurse specialist for them to call if they wish to be included in the study. A second clinic appointment will be made with the co-investigator Miss Karina Cox to re-discuss the trial and obtain written consent. The consultant surgeon is familiar with the process of consent and will determine whether the patient has capacity to give consent for the study. We will exclude all patients with a metabolic disorder, significant co-morbidities and locally advanced or metastatic disease as well as those with a previous history of cancer treatment as the results of the study may be affected by their underlying disorder, previous treatment or current medication.
Confidentiality The study will be conducted within the "Caldicott Principles'. Patients enrolled in the study will be given a unique identification number which will used on samples sent to The University of Kent for experiments. The clinical co-investigator will maintain a secure database of patient identifiable information including demographic and clinico-pathological tumour data.
Conflict of Interest There are no conflicts of interest with this study. Any publications relating to this research will be summarised and distributed to participating patients.
Tissue samples will not be stored indefinitely. All the tissue from the fresh frozen specimens will be used for the experiments. The paraffin slides, once analysed, will be returned from the University of Kent to Maidstone and Tunbridge Wells Pathology Department.
- Conditions
- Breast Cancer
- Being tested
- Association of Myosin VI with oestrogen receptor
- Keywords
- Myosin VI, Estrogen receptor
- Medical subject headings
- Breast Neoplasms, Deafness, Autosomal Recessive 37
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Association of Myosin VI with oestrogen receptorOther
- Gene expression analysis - RNA will be extracted from 100mg of tissue and then subjected to RT-qPCR to determine the relative expression levels of several genes, including MVI and ER Targets. We will use the same approach to determine which isoforms of MVI are expressed in the tissue.
- Protein content analysis - Total protein will be extracted from 100 mg of tissue and western-blot analysis will be used to determine the relative amounts of MVI. Moreover, we will use cell fractionation to determine relative amounts of nuclear versus cytoplasmic protein.
- Genomic analysis - Chromatin-immunoprecipitation (ChIP) experiments we be performed upon 100 mg of tissue sample. Here we will determine the localisation of MVI on the genome within the different tissues.
| Study group | Role | What they receive |
|---|---|---|
| Cases | We will enrol 100 women who have been newly diagnosed with T2 (>2cm) palpable invasive breast cancer having primary surgical treatment at Maidstone Hospital. We will exclude all patients with a metabolic disorder, significant co-morbidities and locally advanced or metastatic disease as well as those with a previous history of cancer treatment. We will collect data on tumour size, grade and phenotype as well as ER, progesterone receptor (PR) and Her-2 expression status and patient demographic information.
We will investigate the Association of Myosin VI with oestrogen receptor. Receives: Other: Association of Myosin VI with oestrogen receptor | |
| Controls | A cohort of control breast tissue will be obtained from 20 patients undergoing benign surgical breast procedures. For those control patients having reduction mammoplasties the excised tissue will be core biopsied but patients having other types of benign surgery will have an extra core biopsy taken from breast tissue surrounding the lesion being excised. Receives: Other: Association of Myosin VI with oestrogen receptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression of Myosin VI and oestrogen receptor targets in tumour tissue.
RT-qPCR experiments to determine relative expression of Myosin VI and oestrogen receptor targets in tumour derived RNA and compare with control breast tissue.
Measured: 24 hours
Quantification of Myosin VI protein in tumour tissue.
Western-blot analysis and cell fractionation to determine relative amounts of Myosin VI compared to total protein extracted from 100mg of tumour tissue in nuclear and cytoplasmic compartments and compare with control tissue.
Measured: 24 hours.
Localisation of Myosin VI on the tumour genome
Chromatin-immunoprecipitation experiments to determine the position of Myosin VI in the tumour genome and compare with control tissue.
Measured: 24 hours.
Secondary outcomes (1)
Comparison of nuclear Myosin VI and oestrogen receptor localisation between different breast cancer prognostic groups.
Immunohistochemisty experiments on paraffin preserved tumour tissue to determine the presence of nuclear Myosin VI and oestrogen receptors and, using a scoring system, compare between breast cancer prognostic groups and control tissue.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start5 May 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maidstone & Tunbridge Wells NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kent
- Responsible party
- Principal investigator, Karina Cox, Maidstone & Tunbridge Wells NHS Trust
- Investigators
- Hazel Everest, Study director, Maidstone and Tunbridge Wells NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430024
- Sponsor's protocol ID
- 17/09/621_Myosin VI
- Status last verified
- Nov 2019
- First submitted
- 11 Jan 2018
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vreugde S, Ferrai C, Miluzio A, Hauben E, Marchisio PC, Crippa MP, Bussi M, Biffo S. Nuclear myosin VI enhances RNA polymerase II-dependent transcription. Mol Cell. 2006 Sep 1;23(5):749-55. doi: 10.1016/j.molcel.2006.07.005.
PubMed 16949370Su AI, Welsh JB, Sapinoso LM, Kern SG, Dimitrov P, Lapp H, Schultz PG, Powell SM, Moskaluk CA, Frierson HF Jr, Hampton GM. Molecular classification of human carcinomas by use of gene expression signatures. Cancer Res. 2001 Oct 15;61(20):7388-93.
PubMed 11606367Dunn TA, Chen S, Faith DA, Hicks JL, Platz EA, Chen Y, Ewing CM, Sauvageot J, Isaacs WB, De Marzo AM, Luo J. A novel role of myosin VI in human prostate cancer. Am J Pathol. 2006 Nov;169(5):1843-54. doi: 10.2353/ajpath.2006.060316.
PubMed 17071605Wang H, Wang B, Zhu W, Yang Z. Lentivirus-Mediated Knockdown of Myosin VI Inhibits Cell Proliferation of Breast Cancer Cell. Cancer Biother Radiopharm. 2015 Oct;30(8):330-5. doi: 10.1089/cbr.2014.1759. Epub 2015 Sep 25.
PubMed 26407123Yoshida H, Cheng W, Hung J, Montell D, Geisbrecht E, Rosen D, Liu J, Naora H. Lessons from border cell migration in the Drosophila ovary: A role for myosin VI in dissemination of human ovarian cancer. Proc Natl Acad Sci U S A. 2004 May 25;101(21):8144-9. doi: 10.1073/pnas.0400400101. Epub 2004 May 14.
PubMed 15146066Spudich G, Chibalina MV, Au JS, Arden SD, Buss F, Kendrick-Jones J. Myosin VI targeting to clathrin-coated structures and dimerization is mediated by binding to Disabled-2 and PtdIns(4,5)P2. Nat Cell Biol. 2007 Feb;9(2):176-83. doi: 10.1038/ncb1531. Epub 2006 Dec 24.
PubMed 17187061Morriswood B, Ryzhakov G, Puri C, Arden SD, Roberts R, Dendrou C, Kendrick-Jones J, Buss F. T6BP and NDP52 are myosin VI binding partners with potential roles in cytokine signalling and cell adhesion. J Cell Sci. 2007 Aug 1;120(Pt 15):2574-85. doi: 10.1242/jcs.007005. Epub 2007 Jul 17.
PubMed 17635994Naccache SN, Hasson T, Horowitz A. Binding of internalized receptors to the PDZ domain of GIPC/synectin recruits myosin VI to endocytic vesicles. Proc Natl Acad Sci U S A. 2006 Aug 22;103(34):12735-40. doi: 10.1073/pnas.0605317103. Epub 2006 Aug 14.
PubMed 16908842
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuclear Myosin VI - a Therapeutic Target in Estrogen Receptor Positive Breast Cancer?
- ClinicalTrials.gov ID
- NCT03430024
- Acronym / sponsor ID
- 17/09/621_Myosin VI
- Conditions
- Breast Cancer
- Keywords
- Myosin VI, Estrogen receptor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Maidstone & Tunbridge Wells NHS TrustUniversity, hospital or other
- Collaborators
- University of Kent
- Study start
- 5 May 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Feb 2018 (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.
Gene expression, the transfer of the genetic code into cellular proteins is one of the most fundamental processes in living cells. This process is orchestrated by protein-based molecular machines, called RNA polymerases that read the DNA sequence to generate messenger RNA (mRNA), which is translated by the cellular machinery to make proteins. Our cells have evolved elaborate regulation mechanisms to control these molecular machines and a breakdown in this regulation leads to diseases such as cancer.
Recently, molecules called myosins have been discovered in the genetic storage compartment of the cell (the nucleus) where they interact with RNA polymerases to regulate protein production. This is interesting because myosins are usually found outside the nucleus transporting cellular cargo or generating muscle contraction. In breast cancer cells, myosin is abundant and interacts with the oestrogen receptor. The majority of breast cancer in the UK is oestrogen receptor positive and activation of this receptor is an important factor controlling the growth of cancer cells. Oestrogen receptor activation appears to be dependent upon myosin and this research project will investigate how myosins are targeted to specific genes and how they are themselves regulated. This will greatly enhance our understanding of the role of nuclear myosins in oestrogen receptor positive breast cancer and may identify a novel therapeutic target for future drug development.
Detailed description
Purpose and Design The primary aim of this project is to understand the significance of the newly discovered interaction between myosin VI (MVI) and the oestrogen receptor in breast cancer cells. The study will investigate the types of genes that MVI regulates and whether the sites of MVI - oestrogen receptor interactions (nucleus or cytoplasm) are important for the expression of oestrogen receptor targets. In breast cancer cells, oestrogen receptors can mutate to become permanently activated, leading to unrestrained tumour growth. Investigating the role of MVI in this metabolic scenario may reveal a potential therapeutic window for hormone refractory oestrogen receptor positive breast cancer.
In order to answer these questions, the methodology will use combination of experiments on established cell lines and patient samples.
The research proposal is a collaborative effort between Dr Chris Toseland (whose group has identified the link between MVI and the oestrogen receptor) at the University of Kent and the Breast Surgery, Pathology and Research and Development departments at Maidstone and Tunbridge Wells NHS Trust.
Recruitment Potential patients for recruitment will be identified at the weekly multi-disciplinary meeting following a diagnosis of primary breast cancer and a decision to proceed with surgery as the first treatment. The actual explanation of the study will take place during the first treatment planning consultation with the treating breast surgeon. The patient will be given written information about the study as well as a contact number of a research nurse/ breast care nurse specialist for them to call if they wish to be included in the study. A second clinic appointment will be made with the co-investigator Miss Karina Cox to re-discuss the trial and obtain written consent. The consultant surgeon is familiar with the process of consent and will determine whether the patient has capacity to give consent for the study. We will exclude all patients with a metabolic disorder, significant co-morbidities and locally advanced or metastatic disease as well as those with a previous history of cancer treatment as the results of the study may be affected by their underlying disorder, previous treatment or current medication.
Confidentiality The study will be conducted within the "Caldicott Principles'. Patients enrolled in the study will be given a unique identification number which will used on samples sent to The University of Kent for experiments. The clinical co-investigator will maintain a secure database of patient identifiable information including demographic and clinico-pathological tumour data.
Conflict of Interest There are no conflicts of interest with this study. Any publications relating to this research will be summarised and distributed to participating patients.
Tissue samples will not be stored indefinitely. All the tissue from the fresh frozen specimens will be used for the experiments. The paraffin slides, once analysed, will be returned from the University of Kent to Maidstone and Tunbridge Wells Pathology Department.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Association of Myosin VI with oestrogen receptorWe will enrol 100 women who have been newly diagnosed with T2 (>2cm) palpable invasive breast cancer having primary surgical treatment at Maidstone Hospital. We will exclude all patients with a metabolic disorder, significant co-morbidities and locally advanced or metastatic disease as well as those with a previous history of cancer treatment. We will collect data on tumour size, grade and phenotype as well as ER, progesterone receptor (PR) and Her-2 expression status and patient demographic information. We will investigate the Association of Myosin VI with oestrogen receptor. |
| Controls | – | Other: Association of Myosin VI with oestrogen receptorA cohort of control breast tissue will be obtained from 20 patients undergoing benign surgical breast procedures. For those control patients having reduction mammoplasties the excised tissue will be core biopsied but patients having other types of benign surgery will have an extra core biopsy taken from breast tissue surrounding the lesion being excised. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Tissue will be obtained from patients diagnosed with early invasive breast cancer undergoing primary surgery. We will enrol 100 women who have been newly diagnosed with T2 (>2cm) palpable invasive breast cancer having primary surgical treatment at Maidstone Hospital.
Key inclusion criteria (3 listed)
- Clinical diagnosis of early breast cancer
- Palpable tumour greater than 2cm
- Scheduled for primary surgical treatment
Key exclusion criteria (4 listed)
- Locally advanced breast cancer
- Metastatic breast cancer
- Significant co-morbidities (ASA 4 or above)
- Past history of breast cancer
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 |
|---|---|---|
| Association of Myosin VI with oestrogen receptor1. Gene expression analysis - RNA will be extracted from 100mg of tissue and then subjected to RT-qPCR to determine the relative expression levels of several genes, including MVI and ER Targets. We will use the same approach to determine which isoforms of MVI are expressed in the tissue. 2. Protein content analysis - Total protein will be extracted from 100 mg of tissue and western-blot analysis will be used to determine the relative amounts of MVI. Moreover, we will use cell fractionation to determine relative amounts of nuclear versus cytoplasmic protein. 3. Genomic analysis - Chromatin-immunoprecipitation (ChIP) experiments we be performed upon 100 mg of tissue sample. Here we will determine the localisation of MVI on the genome within the different tissues. | Other | Cases, Controls |
Primary outcome
Gene expression of Myosin VI and oestrogen receptor targets in tumour tissue.
Time frame: 24 hours
RT-qPCR experiments to determine relative expression of Myosin VI and oestrogen receptor targets in tumour derived RNA and compare with control breast tissue.
Quantification of Myosin VI protein in tumour tissue.
Time frame: 24 hours.
Western-blot analysis and cell fractionation to determine relative amounts of Myosin VI compared to total protein extracted from 100mg of tumour tissue in nuclear and cytoplasmic compartments and compare with control tissue.
Localisation of Myosin VI on the tumour genome
Time frame: 24 hours.
Chromatin-immunoprecipitation experiments to determine the position of Myosin VI in the tumour genome and compare with control tissue.
1 secondary outcome
Comparison of nuclear Myosin VI and oestrogen receptor localisation between different breast cancer prognostic groups.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Background: PubMed 16949370Vreugde S, Ferrai C, Miluzio A, Hauben E, Marchisio PC, Crippa MP, Bussi M, Biffo S. Nuclear myosin VI enhances RNA polymerase II-dependent transcription. Mol Cell. 2006 Sep 1;23(5):749-55. doi: 10.1016/j.molcel.2006.07.005.
- Background: PubMed 11606367Su AI, Welsh JB, Sapinoso LM, Kern SG, Dimitrov P, Lapp H, Schultz PG, Powell SM, Moskaluk CA, Frierson HF Jr, Hampton GM. Molecular classification of human carcinomas by use of gene expression signatures. Cancer Res. 2001 Oct 15;61(20):7388-93.
- Background: PubMed 17071605Dunn TA, Chen S, Faith DA, Hicks JL, Platz EA, Chen Y, Ewing CM, Sauvageot J, Isaacs WB, De Marzo AM, Luo J. A novel role of myosin VI in human prostate cancer. Am J Pathol. 2006 Nov;169(5):1843-54. doi: 10.2353/ajpath.2006.060316.
- Background: PubMed 26407123Wang H, Wang B, Zhu W, Yang Z. Lentivirus-Mediated Knockdown of Myosin VI Inhibits Cell Proliferation of Breast Cancer Cell. Cancer Biother Radiopharm. 2015 Oct;30(8):330-5. doi: 10.1089/cbr.2014.1759. Epub 2015 Sep 25.
- Background: PubMed 15146066Yoshida H, Cheng W, Hung J, Montell D, Geisbrecht E, Rosen D, Liu J, Naora H. Lessons from border cell migration in the Drosophila ovary: A role for myosin VI in dissemination of human ovarian cancer. Proc Natl Acad Sci U S A. 2004 May 25;101(21):8144-9. doi: 10.1073/pnas.0400400101. Epub 2004 May 14.
- Background: PubMed 17187061Spudich G, Chibalina MV, Au JS, Arden SD, Buss F, Kendrick-Jones J. Myosin VI targeting to clathrin-coated structures and dimerization is mediated by binding to Disabled-2 and PtdIns(4,5)P2. Nat Cell Biol. 2007 Feb;9(2):176-83. doi: 10.1038/ncb1531. Epub 2006 Dec 24.
- Background: PubMed 17635994Morriswood B, Ryzhakov G, Puri C, Arden SD, Roberts R, Dendrou C, Kendrick-Jones J, Buss F. T6BP and NDP52 are myosin VI binding partners with potential roles in cytokine signalling and cell adhesion. J Cell Sci. 2007 Aug 1;120(Pt 15):2574-85. doi: 10.1242/jcs.007005. Epub 2007 Jul 17.
- Background: PubMed 16908842Naccache SN, Hasson T, Horowitz A. Binding of internalized receptors to the PDZ domain of GIPC/synectin recruits myosin VI to endocytic vesicles. Proc Natl Acad Sci U S A. 2006 Aug 22;103(34):12735-40. doi: 10.1073/pnas.0605317103. Epub 2006 Aug 14.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hazel Everest study director
Maidstone and Tunbridge Wells NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Maidstone & Tunbridge Wells NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karina Cox, MD (00 45 1622 22 4111, karina.cox@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression of Myosin VI and oestrogen receptor targets in tumour tissue. (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03430024, which also lists 8 linked publications.
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 13 Nov 2019.