Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- concentration of exosomes in blood
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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
排除标准
- •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.
研究组 & 干预措施
Localized sarcoma with neoadjuvant chemotherapy
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
干预措施: Blood samples (Biological)
Metastatic or locally advanced sarcoma
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
干预措施: Blood samples (Biological)
结局指标
主要结局
concentration of exosomes in blood
时间窗: up to 6 months after inclusion
blood samples
次要结局
未报告次要终点