Informations générales (source: ClinicalTrials.gov)

NCT03800121 En recrutement
Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC) (EXOSARC)
Observational
  • Sarcomes
Centre Georges Francois Leclerc (Voir sur ClinicalTrials)
novembre 2018
novembre 2025
29 juin 2024
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.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Georges François Leclerc - 21000 - Dijon - France Alice HERVIEU En recrutement Contact (sur clinicalTrials)
CHU de Besançon - 25000 - Besançon - France Loic CHAIGNEAU En recrutement Contact (sur clinicalTrials)
CHU de Poitiers - 86000 - Poitiers - France Nicolas ISAMBERT, PU-PH En recrutement Contact (sur clinicalTrials)

Critères

Tous
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



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.