Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC) (EXOSARC)
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|ClinicalTrials.gov Identifier: NCT03800121|
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : March 15, 2019
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.
|Condition or disease||Intervention/treatment|
|Sarcoma||Biological: Blood samples|
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,
- metastatic before and after treatment with 1st line chemotherapy.
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 :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC)|
|Actual Study Start Date :||November 19, 2018|
|Estimated Primary Completion Date :||November 19, 2020|
|Estimated Study Completion Date :||November 19, 2020|
localized and metastatic sarcomas
In total, several blood tests specific to the EXOSARC study will be necessary:
Biological: Blood samples
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)
- concentration of exosomes in blood [ Time Frame: up to 6 months after inclusion ]blood samples
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800121
|Contact: Nicolas ISAMBERT, PU PH||03 80 73 75 firstname.lastname@example.org|
|Contact: Emilie REDERSTORFF||03 80 73 75 email@example.com|
|Centre Georges François Leclerc||Recruiting|
|Dijon, France, 21000|
|Contact: Nicolas ISAMBERT 03 80 73 75 00 firstname.lastname@example.org|