Clinical trial · Observational
Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients
NCT07432932CI-TRIAL-00104036PANTHR-SrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Angiosarcoma | Angiosarcoma | ONTOLOGY_EXACT | 0.90 |
| Leiomyosarcoma (LMS) | Leiomyosarcoma | ONTOLOGY_EXACT | 0.85 |
| Liposarcoma | Liposarcoma | ONTOLOGY_EXACT | 0.90 |
| Liposarcoma, Dedifferentiated | Dedifferentiated Liposarcoma | ONTOLOGY_EXACT | 0.98 |
| Retroperitoneal Sarcoma | Retroperitoneal Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Sarcoma, Leiomyo-, Adult | Sarcoma | ONTOLOGY_EXACT | 0.85 |
| Sarcoma, Synovial, Adult | Synovial Sarcoma | ONTOLOGY_EXACT | 0.85 |
| Soft Tissue Sarcoma Adult | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational Translational Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Prospective
- description
- 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.
- interventionNames
- Other: Observational Translational Study
- label
- Retrospective
- description
- Retrospective cohort study: a cohort of patients who advanced directly to surgery ("Control group") and a cohort treated with NCT.
- interventionNames
- Other: Observational Translational Study
Primary outcomes (5)
- measure
- Identify a difference in expression profiles, using proteomics, genomics, epigenomics, in tissue samples obtained pre- and post-NCT and post-surgery alone
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* 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
Exclusion Criteria:
-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 conditionsReferences
Publications (0)
Data not yet available
No reference posted for this study.