Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC) (EXOSARC)
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.
Study Overview
Detailed Description
The main objective of this pilot study is to quantify exosomes and analyze their protein and RNA content in patients with sarcoma with disease:
- localized before and after treatment with surgery,
- localized for which neoadjuvant chemotherapy is being considered
- metastatic or locally advanced cancer before and after treatment with first-line chemotherapywhich may include neoadjuvant therapy
The secondary objectives are:
- Determine whether the initial exosome concentration and the protein and RNA profile they contain vary with the localized or metastatic stage of the disease.
- Determine if the exosome concentration as well as the protein and RNA profile they contain varies after treatment.
- Determine if the initial exosome concentration (at T0) is associated with a response to treatment.
- Determine whether the change in exosome concentration before and after treatment is associated with a response to treatment.
- Identify a protein marker or RNA associated with a treatment response (marker present at T0 or occurring during follow-up).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Besançon, France, 25000
- CHU De Besancon
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Dijon, France, 21000
- Centre Georges Francois Leclerc
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Poitiers, France, 86000
- CHU de Poitiers
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Men and women newly diagnosed with localized, metastatic or locally advanced soft tissue sarcoma
- 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.
- For metastatic or locally advanced (inoperable) sarcoma, patients for whom first-line metastatic chemotherapy is indicated.
- Age ≥18 years
- Affiliation to a social security scheme
- 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:
- Patient with another synchronous tumor,
- Patient with sarcoma in irradiated territory
- Patient with a history of cancer other than sarcoma in the 5 years preceding the diagnosis of sarcoma
- Patient unable to undergo medical follow-up for geographical, social or psychological reasons,
- Person benefiting from a protection system for adults (including guardianship and trusteeship),
- Serology HIV and / or HBV and / or HCV positive.
- Pregnant or lactating woman.
- Patients unable to understand, read and / or sign informed consent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Localized sarcoma with neoadjuvant chemotherapy
In total, several blood tests specific to the EXOSARC study will be necessary:
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Localized sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample before surgery (32 ml) + 1 blood sample 1 month after surgery (32 ml) + 1 blood sample 3 month after surgery (32 ml) + 1 blood sample 6 month after surgery (32 ml) Metastatic sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample during chemotherapy cure 1 (32 ml) + 1 blood sample during chemotherapy cure 3 (32 ml) + 1 blood sample during chemotherapy cure 6 (32 ml)
Other Names:
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Metastatic or locally advanced sarcoma
In total, several blood tests specific to the EXOSARC study will be necessary :
|
Localized sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample before surgery (32 ml) + 1 blood sample 1 month after surgery (32 ml) + 1 blood sample 3 month after surgery (32 ml) + 1 blood sample 6 month after surgery (32 ml) Metastatic sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample during chemotherapy cure 1 (32 ml) + 1 blood sample during chemotherapy cure 3 (32 ml) + 1 blood sample during chemotherapy cure 6 (32 ml)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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concentration of exosomes in blood
Time Frame: up to 6 months after inclusion
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blood samples
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up to 6 months after inclusion
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A01393-52
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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