Trials / Recruiting

RecruitingNCT07432932

Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 800 (estimated)

Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
OTHER	Observational Translational Study	Cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT)

Timeline

Start date: 2021-11-19
Primary completion: 2026-03-31
Completion: 2028-06-30
First posted: 2026-02-25
Last updated: 2026-02-25

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT07432932. Inclusion in this directory is not an endorsement.