Clinical trial · Observational
Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC)
- 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)
Sarcomas are rare cancers with a high risk of metastatic progression and a major pejorative factor with respect to patient survival. The estimation of the metastatic risk of sarcomas is very complex given the histological heterogeneity of this entity. It is therefore essential that, at diagnosis, a reliable evaluation of this metastatic potential be made, in order to adapt the therapeutic strategy as well as possible. It has recently been discovered that sarcomas secrete many exosomes that appear to play an important role in tumorogenesis, growth, tumor progression and the onset of metastases. They contain many proteins and nucleic acids (DNA, RNA, microRNA), reflecting the characteristics of the tumor. It has been shown that the amount of exosomes can be correlated with the grade of malignancy of the tumor. Present in the blood, exosomes offer the possibility of non-invasively analyzing the molecular information of the cancer cell. As a result, the study of serum exosomes derived from sarcomas has a high potential as a liquid biopsy to evaluate cancer pathogenesis, progression, and treatment efficacy. The purpose of this study is to demonstrate in patients with sarcomas that exosomes can be used to monitor their disease and be used as a predictor of the risk of recurrence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Localized sarcoma with neoadjuvant chemotherapy
- description
- In total, several blood tests specific to the EXOSARC study will be necessary: * A first blood test of 7 mL during the initial assessment (inclusion) * Then four blood samples of 32mL distributed over 6 months
- interventionNames
- Biological: Blood samples
- label
- Metastatic or locally advanced sarcoma
- description
- In total, several blood tests specific to the EXOSARC study will be necessary : * A first blood of 7 mL during the initial assessment (inclusion) * Then three blood samples of 32 mL distribuated over 3 months
- interventionNames
- Biological: Blood samples
Primary outcomes (1)
- measure
- concentration of exosomes in blood
- timeFrame
- up to 6 months after inclusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men and women newly diagnosed with localized, metastatic or locally advanced soft tissue sarcoma 2. Previous treatment of the disease with chemotherapy, radiotherapy or surgery is allowed if it has been completed for more than 12 months at the time of inclusion. 3. For metastatic or locally advanced (inoperable) sarcoma, patients for whom first-line metastatic chemotherapy is indicated. 4. Age ≥18 years 5. Affiliation to a social security scheme 6. Patients who signed informed consent to participate in the study Exclusion Criteria: Patients who meet at least one of the following criteria will not be eligible: 1. Patient with another synchronous tumor, 2. Patient with sarcoma in irradiated territory 3. Patient with a history of cancer other than sarcoma in the 5 years preceding the diagnosis of sarcoma 4. Patient unable to undergo medical follow-up for geographical, social or psychological reasons, 5. Person benefiting from a protection system for adults (including guardianship and trusteeship), 6. Serology HIV and / or HBV and / or HCV positive. 7. Pregnant or lactating woman. 8. Patients unable to understand, read and / or sign informed consent.
References
Publications (1)
- DERIVEDVautrot V, Hervieu A, Bertaut A, Charon-Barra C, Naiken I, Causseret S, Chaigneau L, Desmoulins I, Rederstoff E, Isambert N, Gobbo J. Small Extracellular Vesicles as Biomarkers in Sarcoma Follow-Up: Protocol for a Prospective, Multicentric Pilot Study. JMIR Res Protoc. 2025 Sep 9;14:e63718. doi: 10.2196/63718. PMID 40925003