An observational study in Sarcoma, Sarcoma, Leiomyo-, Adult and Sarcoma, Synovial, Adult, sponsored by Royal Marsden NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by Royal Marsden NHS Foundation Trust · Observational
This is a cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT) in high-risk soft tissue sarcoma (STS) patients with dedifferentiated liposarcoma (DDLPS), leiomyosarcoma (LMS), synovial sarcoma (SS), vascular sarcomas, malignant peripheral nerve sheath tumour (MPNST) or other subtypes. It comprises of both retrospective and prospective tissue collection from patients advancing directly to surgery (control group) and patients receiving NCT and surgery.
This is a multi-centre collaborative study across four countries which aims to accelerate precision medicine approaches for neoadjuvant therapy in high risk sarcomas.
The study will include both prospective and retrospective patient identification and inclusion from two cohorts; patients who advanced to surgery alone or received surgery and NCT. The participating local centres will continue pre-approved established data and tissue collection processes. Collaboration with external sites will allow the recruitment of a larger cohort of patients to be included in analyses.
Patients will be recruited for the study from each of the following five centres: The Royal Marsden Hospital, The Beatson West of Scotland Centre Glasgow, Birmingham NHS Trust, Fondazione IRCCS Istituto Nazionale dei Tumori and Hospital Universitario Virgen del Rocio/Instituto de Biomedicina de Sevilla.
Translational research analysis will be undertaken at all three centres. Pseudonymised clinical data and tissue samples from each centre will be sent to the centre responsible for the specific component of the project. The transfer of material and data will be undertaken in accordance with Human Tissue Authority (HTA) regulation, and appropriate MTAs will be put in place prior to the transfer of any tissue between sites. A data protection checklist will also be completed and reviewed by the information governance team of each institution to ensure all pseudonymised data shared by collaborating sites is dealt with appropriately and adheres to the responsibilities of each institution relating to patient confidentiality and appropriate data handling practices.
1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.
This study's planned enrollment of 800 is above the median of 120 across 218 observational studies indexed under Sarcoma.
Browse Sarcoma studies →Royal Marsden NHS Foundation Trust is the lead sponsor of 273 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with one of DDLPS, LMS, SS, vascular sarcomas or MPNST either advancing directly to surgery or receiving neoadjuvant chemotherapy and surgery
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.
Written for the prospective cohort
High-risk sarcoma definition:
Have disease amenable to
o Patients who are not amenable to repeat biopsy at baseline can be reviewed with the local site PI for consideration of inclusion to the study
Exclusion Criteria:
-Prior invasive in last 5 years, low risk malignancies in the last 5 years may be reviewed by the PI.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Prospective observational cohort study: a cohort of patients advancing directly to surgery ("Control group") and Prospective cohort receiving neo-adjuvant chemotherapy. Prospectively enrolled patients with STS, tissue samples pre-chemotherapy and from surgical resection will undergo epigenetic, proteomic and genomic profiling to define the biology at two distinct time points.
Other: Observational Translational Study
Retrospective cohort study: a cohort of patients who advanced directly to surgery ("Control group") and a cohort treated with NCT.
Other: Observational Translational Study
Cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT)
Identify a difference in expression profiles, using proteomics, genomics, epigenomics, in tissue samples obtained pre- and post-NCT and post-surgery alone
Time frame: Through study completion, average 4 years
Develop an understanding of radiomic profiles for patients treated with NCT.
Time frame: Through study completion, average 4 years
Develop an electronic STS Tissue Atlas for 5 high risk subtypes.
Time frame: Through study completion, average 4 years
Develop and characterize patient derived models to investigate biology of high-risk sarcomas and directly test predicted therapeutic interventions
Time frame: Through study completion, average 4 years
Develop a nomogram app to predict benefit of NCT and predict risk of recurrence.
Time frame: Through study completion, average 4 years
To assess whether there is a difference in metastases-free survival (MFS), recurrence free survival (RFS) and overall survival (OS) between patients with high risk STS who receive NCT compared to those who do not receive NCT
Time frame: Through study completion, average 4 years
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2021 (actual). Primary completion is estimated for Mar 2026, 52 months after the start.
Of 88 non-industry observational studies under Sarcoma, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 294. This study's planned 52 months is below that.
Counting every sponsor, half of 97 studies reached it within 66 months; a quarter within 42 and three quarters within 294.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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