Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Identify a difference in expression profiles, using proteomics, genomics, epigenomics, in tissue samples obtained pre- and post-NCT and post-surgery alone
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent for the prospective cohort
- •Histopathological diagnosis of high-risk soft tissue sarcoma and one of the following subtypes: DDLPS, LMS, SS, vascular sarcomas or MPNST. Other subtypes may be included with PI approval.
- •High-risk sarcoma definition:
- •Greater than 5cm or Grade 3
- •Deep anatomic location
- •Have disease amenable to biopsy
- •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
- •Resectable tumour
- •Measurable disease by RECIST 1.1
- •Aged ≥ 18 years
- •WHO performance status 0-2
- •For patients receiving NCT, medically fit enough, with adequate organ function, to undergo neoadjuvant chemotherapy
- •Patients medically fit enough to undergo surgical resection
- •Capable of giving written informed consent (for prospective cohort) and comply with the study schedule
- •Patients may also participate in the STRASS 2 trial
排除标准
- •Prior invasive malignancy in last 5 years, low risk malignancies in the last 5 years may be reviewed by the PI.
- •Known additional malignancy that is progressing or requires active treatment
- •Metastatic disease not amenable to curative intent local therapy
- •Any active uncontrolled medical conditions
研究组 & 干预措施
Prospective
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.
干预措施: Observational Translational Study (Other)
Retrospective
Retrospective cohort study: a cohort of patients who advanced directly to surgery ("Control group") and a cohort treated with NCT.
干预措施: Observational Translational Study (Other)
结局指标
主要结局
Identify a difference in expression profiles, using proteomics, genomics, epigenomics, in tissue samples obtained pre- and post-NCT and post-surgery alone
时间窗: Through study completion, average 4 years
Develop an understanding of radiomic profiles for patients treated with NCT.
时间窗: Through study completion, average 4 years
Develop an electronic STS Tissue Atlas for 5 high risk subtypes.
时间窗: 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
时间窗: Through study completion, average 4 years
Develop a nomogram app to predict benefit of NCT and predict risk of recurrence.
时间窗: Through study completion, average 4 years
次要结局
- 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(Through study completion, average 4 years)