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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
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Brief Summary:

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

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,
  • metastatic before and after treatment with 1st line chemotherapy.

The secondary objectives are:

  1. Determine whether the initial exosome concentration and the protein and RNA profile they contain vary with the localized or metastatic stage of the disease.
  2. Determine if the exosome concentration as well as the protein and RNA profile they contain varies after treatment.
  3. Determine if the initial exosome concentration (at T0) is associated with a response to treatment.
  4. Determine whether the change in exosome concentration before and after treatment is associated with a response to treatment.
  5. Identify a protein marker or RNA associated with a treatment response (marker present at T0 or occurring during follow-up).

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
localized and metastatic sarcomas

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 (localized sarcoma group) or three blood samples of 32mL performed during chemotherapy treatments (metastatic sarcoma group).
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)

Other Names:
  • Localized sarcoma
  • Metastatic sarcoma




Primary Outcome Measures :
  1. concentration of exosomes in blood [ Time Frame: up to 6 months after inclusion ]
    blood samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with sarcoma: liposarcoma, leiomyosarcoma (LMS), pleomorphous undifferentiated sarcoma (UPS)
Criteria

Inclusion Criteria:

  1. Men and women diagnosed with localized or metastatic soft tissue sarcoma (liposarcoma, LMS or UPS)
  2. Naïve treatment
  3. For metastatic forms, patient for whom treatment with anthracyclines is considered.
  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.
  9. Patient not immediately operable for cohort 1 (localized disease)

Information from the National Library of Medicine

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


Contacts
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Contact: Nicolas ISAMBERT, PU PH 03 80 73 75 00 nisambert@cgfl.fr
Contact: Emilie REDERSTORFF 03 80 73 75 00 erederstorff@cgfl.fr

Locations
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France
Centre Georges François Leclerc Recruiting
Dijon, France, 21000
Contact: Nicolas ISAMBERT    03 80 73 75 00    nisambert@cgfl.fr   
Sponsors and Collaborators
Centre Georges Francois Leclerc

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Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT03800121     History of Changes
Other Study ID Numbers: EXOSARC
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Georges Francois Leclerc:
exosomes

Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms