SarcomaEXOSARCNCT03800121
Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC)
An observational study of Sarcoma, run by Centre Georges Francois Leclerc at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Blood samples
- How many people
- 34 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Nov 2018to 19 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with soft tissue sarcoma
Who may be able to join
- 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
Who cannot join
- 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),
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- Serology HIV and / or HBV and / or HCV positive.
- Pregnant or lactating woman.
- Patients unable to understand, read and / or sign informed consent.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Besançon
Besançon, 25000
Centre Georges François Leclerc
Dijon, 21000
CHU de Poitiers
Poitiers, 86000
About this study
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.
Read the 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).
- Conditions
- Sarcoma
- Being tested
- Blood samples
- Keywords
- exosomes
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
Also called Localized sarcoma, Metastatic sarcoma
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Blood samples | |
| 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 Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of exosomes in blood
blood samples
Measured: up to 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start19 Nov 2018
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR1231 Lipids Nutrition Cancer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800121
- Sponsor's protocol ID
- 2018-A01393-52
- Acronym
- EXOSARC
- Status last verified
- Jun 2025
- First submitted
- 3 Jan 2019
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vautrot V, Hervieu A, Bertaut A, Charon-Barra C, Naiken I, Causseret S, Chaigneau L, Desmoulins I, Rederstoff E, Isambert N, Gobbo J. Small Extracellular Vesicles as Biomarkers in Sarcoma Follow-Up: Protocol for a Prospective, Multicentric Pilot Study. JMIR Res Protoc. 2025 Sep 9;14:e63718. doi: 10.2196/63718.
PubMed 40925003
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC)
- ClinicalTrials.gov ID
- NCT03800121
- Acronym / sponsor ID
- EXOSARC / 2018-A01393-52
- Conditions
- Sarcoma
- Keywords
- exosomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Collaborators
- INSERM UMR1231 Lipids Nutrition Cancer
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Localized sarcoma with neoadjuvant chemotherapy | – | Biological: Blood samplesIn 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 |
| Metastatic or locally advanced sarcoma | – | Biological: Blood samplesIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with soft tissue sarcoma
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesAlso: Localized sarcoma, Metastatic sarcomaLocalized 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) | Biological | Localized sarcoma with neoadjuvant chemotherapy, Metastatic or locally advanced sarcoma |
Primary outcome
concentration of exosomes in blood
Time frame: up to 6 months after inclusion
blood samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Derived from this study: PubMed 40925003Vautrot V, Hervieu A, Bertaut A, Charon-Barra C, Naiken I, Causseret S, Chaigneau L, Desmoulins I, Rederstoff E, Isambert N, Gobbo J. Small Extracellular Vesicles as Biomarkers in Sarcoma Follow-Up: Protocol for a Prospective, Multicentric Pilot Study. JMIR Res Protoc. 2025 Sep 9;14:e63718. doi: 10.2196/63718.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Centre Georges Francois Leclerc at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of exosomes in blood (time frame: up to 6 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03800121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.