An observational study in Breast Cancer, sponsored by Maidstone & Tunbridge Wells NHS Trust. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Maidstone & Tunbridge Wells NHS Trust · Observational
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Among 757 studies in Breast Neoplasms with a site in United Kingdom — 98 open to participants now, 196 under way, 67 of them phase 3. Breast Neoplasms · United Kingdom.
Among the 757 studies in Breast Neoplasms with a site in United Kingdom, this one is the 69th largest by planned enrollment of the 122 observational ones that give a count, is one of 39 that started in 2019, is one of 123 observational ones, and was the 472nd registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →98 of the 757 studies in Breast Neoplasms with a site in United Kingdom are open now. Recruiting first, the newest first:
Zedsen Limited · Sites in United Kingdom
Ages 18–85 · Women only
University Hospitals of North Midlands NHS Trust · Sites in United Kingdom
Ages 18+ · Women only
Imperial College London · Sites in United Kingdom
Ages 16–100
BeOne Medicines · Sites in United Kingdom, United States, Australia and 13 more countries
Ages 18+
Hoffmann-La Roche · Sites in United Kingdom, United States, Argentina and 23 more countries
Ages 18+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years to 85 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
757 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 125 · Phase 2 238 · Phase 3 229 · Phase 4 7
First in 1987; this study’s year is marked. 39 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Median enrollment 221 across the 613 interventional studies, 221 across the 122 observational. Of the 451 that completed or were terminated, 201 (45%) have results posted.
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422 of 757 have an industry lead sponsor. The 10 most frequent:
Maidstone & Tunbridge Wells NHS Trust is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Maidstone & Tunbridge Wells NHS Trust has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
48 of the studies in Breast Neoplasms with a site in United Kingdom that are under way reach primary completion within a year, 13 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04873362Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy | 2027-03-31 |
| NCT05696626Phase 3LeonaBioEvaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation | 2027-04 |
| NCT04421963Phase 3AstraZenecaRoll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib | 2027-04-06 |
| NCT05774951Phase 3AstraZenecaA Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy | 2027-04-20 |
| NCT04784715Phase 3AstraZenecaTrastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | 2027-05-03 |
Add all 48 to your calendar (.ics) → With an account.
Among the 757 studies in Breast Neoplasms with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Association of Myosin VI with oestrogen receptor
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.
Other: Association of Myosin VI with oestrogen receptor
1. 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours.
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.
Time frame: 3 months
Plan to share: No
Started May 2019 (actual). Primary completion is estimated for Dec 2020, 19 months after the start.
Of 1,192 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 138. This study's planned 19 months is below that.
Counting every sponsor, half of 1,381 studies reached it within 55 months; a quarter within 25 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Maidstone & Tunbridge Wells NHS Trust