Soft Tissue SarcomaMIRASNCT03967834
Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
A study testing Patient with Soft Tissue Sarcoma in people with Soft Tissue Sarcoma and Clear Cell Sarcoma, run by Institut Claudius Regaud at 20 sites in France.
Trial summary
This trial is a translational, open-label, multi-sites, prospective and retrospective cohort study of 500 patients aimed at clinical and biological characterization of sarcoma of rare subtype. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma, Clear Cell Sarcoma, Epithelioid Sarcoma
- What is being tested?
- Patient with Soft Tissue Sarcoma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 20 sitesFrance
- Study dates
- 26 Apr 2021to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥18 years at the time of study entry.
- Diagnosis of one of the following rare sarcoma subtype, confirmed by RRePS network:
- Clear Cell Sarcoma (CCS)
- Epithelioid Sarcoma (ES)
- Perivascular Epithelioid Cell neoplasm (PEComa)
- Desmoplastic Small Round Cell Tumours (DSRCT)
Show all 20Show fewer
- Malignant Solitary Fibrous Tumours (mSFT)
- Alveolar Soft Part Sarcoma (ASPS)
- Epithelioid Hemangioendothelioma (EH)
- Low-Grade Fibromyxoid Sarcoma (LGFS)
- Sclerosing Epithelioid Fibrosarcoma (SEF).
- Localized/locally advanced or metastatic disease.
- In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision).
- In case of metastatic disease, project of new line of systemic treatment must have been decided before inclusion.
- Patient followed in the center within a standard of care procedure or clinical trial.
- Archived tumor specimen at initial diagnosis available (before treatment initiation).
- Evaluable disease (measurable as per RECIST 1.1) or not.
- ECOG Performance status 0-3.
- Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
- Patient affiliated to a Social Health Insurance in France.
Who cannot join
- Diagnosis of all other histotypes of soft tissue sarcoma.
- Any condition contraindicated with procedures required by the protocol.
- Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
- Pregnant or breast-feeding woman.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 17 recruiting
- Recruiting
Chu Besancon - Site Jean Minjoz
Besançon, 25000
Loic CHAIGNEAU, 03 70 63 24 03, lchaigneau@chu-besancon.fr
- Recruiting
Institut Bergonié
Bordeaux
Maud TOULMONDE, 05 56 33 34 48, m.toulmonde@bordeaux.unicancer.fr
- Recruiting
Centre Jean Perrin
Clermont-Ferrand, 63011
Pascale DUBRAY-LONGERAS, 04 73 27 81 41, pascale.dubray-longeras@clermont.unicancer.fr
- Not yet recruiting
Centre Georges François Leclerc
Dijon
Alice HERVIEU, Dr, 03 80 73 75 06, ahervieu@cgfl.fr
- Recruiting
Centre Oscar Lambret
Lille, 59020
Loïc LEBELLEC, 03 20 29 59 59, l-lebellec@o-lambret.fr
- Recruiting
Chu Dupuytren
Limoges
Valérie LE BRUN-LY, 05 55 05 61 00, valerie.lebrunly@chu-limoges.fr
- Recruiting
Centre Leon Berard
Lyon, 69008
Armelle DUFRESNE, 04 69 85 61 47, armelle.dufresne@lyon.unicancer.fr
- Withdrawn
Institut Paoli-Calmettes
Marseille, 13009
- Recruiting
Chu de Marseille - Hopital de La Timone
Marseille
Sébastien SALAS, 04 91 38 57 08, sebastien.salas@ap-hm.fr
- Recruiting
Centre Antoine Lacassagne
Nice, 06189
Esma SAADA-BOUZID, 04 92 03 15 14, esma.saada-bouzid@nice.unicancer.fr
- Recruiting
Hôpital Cochin - Site Port-Royal
Paris
Pascaline BOUDOU-ROUQUETTE, 01 58 41 14 39, pascaline.boudou@aphp.fr
- Recruiting
Institut Curie
Paris
Sarah WATSON, sarah.watson@curie.fr
- Recruiting
Chu Poitiers
Poitiers
Nicolas ISAMBERT, 05 49 44 45 48, nicolas.isambert@chu-poitiers.fr
- Recruiting
Institut Godinot
Reims
SOIBINET-OUDOT Pauline, 03 26 50 43 83, pauline.soibinet@reims.unicancer.fr
- Recruiting
Centre Eugene Marquis
Rennes
Xavier CHODERLOS DE LACLOS, 02 99 25 31 13, x.choderlos-de-laclos@rennes.unicancer.fr
- Withdrawn
Institut de Cancerologie de L'Ouest - Site Rene Gauducheau
Saint-Herblain, 44805
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg
Jean-Emmanuel KURTZ, 0368767374, JeanEmmanuel.KURTZ@chru-strasbourg.fr
- Recruiting
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse
Thibaud VALENTIN, +33 (0)5 31 15 51 70, Valentin.Thibaud@iuct-oncopole.fr
- Recruiting
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Maria RIOS, 03 83 59 84 61, m.rios@nancy.unicancer.fr
- Withdrawn
Institut Gustave Roussy
Villejuif, 94805
About this study
This trial is a translational, open-label, multi-sites, prospective and retrospective cohort study of 500 patients aimed at clinical and biological characterization of sarcoma of rare subtype.
400 patients will be included in this prospective cohort study; they will be identified in the investigating centers in the context of either routine care or a clinical study protocol.
Retrospective cases of patients (100 cases in total) will be identified in all centers through the GSF/GETO clinical databases already setted up (including the clinical base Conticabase).
- Conditions
- Soft Tissue Sarcoma, Clear Cell Sarcoma, Epithelioid Sarcoma, Perivascular Epithelioid Cell Neoplasms, Desmoplastic Small Round Cell Tumor, Malignant Solitary Fibrous Tumors
- Being tested
- Patient with Soft Tissue Sarcoma
- Keywords
- Soft Tissue Sarcoma, Clear Cell Sarcoma, Epithelioid Sarcoma, Perivascular Epithelioid Cell Neoplasms, Desmoplastic Small Round Cell Tumor, Malignant Solitary Fibrous Tumors, Alveolar Soft Part Sarcoma, Epithelioid Hemangioendothelioma, Low Grade Fibromyxoid Sarcoma, Sclerosing Epithelioid Fibrosarcoma
- Medical subject headings
- Sarcoma, Sarcoma, Clear Cell, Perivascular Epithelioid Cell Neoplasms, Desmoplastic Small Round Cell Tumor, Sarcoma, Alveolar Soft Part, Hemangioendothelioma, Epithelioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient with Soft Tissue SarcomaOther
- Tumor specimens will be collected for the study at diagnosis.
- A blood sample will be collected in all included patients at baseline, after the completion of the treatment (for patients included with a localized disease) or at the time of the first tumoral evaluation (for patients included with a metastatic disease), and at the time of progression.
- Patient's data (clinical, biological and disease data) will also be collected at baseline visit and then at each time point planned in the center for clinical benefit assessment (i.e. every 2 or 3 months) until progression or for a maximum duration of 5 years.
| Study group | Role | What they receive |
|---|---|---|
| Patient with Soft Tissue Sarcoma (Prospective cohort) | Other | Not described Receives: Other: Patient with Soft Tissue Sarcoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastasis-free survival for patients with localized disease.
Measured: 60 months for each patients
Progression-free survival for patients with metastatic disease.
Measured: 60 months for each patients
Secondary outcomes (3)
Cancer-Testis Antigens (CTA) expression.
Measured: 60 months for each patients
The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature.
Measured: 60 months for each patients
Overall survival.
Measured: 60 months for each patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start26 Apr 2021
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967834
- Sponsor's protocol ID
- 19 SARC 04
- Acronym
- MIRAS
- Status last verified
- Feb 2026
- First submitted
- 27 May 2019
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
- ClinicalTrials.gov ID
- NCT03967834
- Acronym / sponsor ID
- MIRAS / 19 SARC 04
- Conditions
- Soft Tissue Sarcoma, Clear Cell Sarcoma, Epithelioid Sarcoma, Perivascular Epithelioid Cell Neoplasms, Desmoplastic Small Round Cell Tumor, Malignant Solitary Fibrous Tumors
- Keywords
- Soft Tissue Sarcoma, Clear Cell Sarcoma, Epithelioid Sarcoma, Perivascular Epithelioid Cell Neoplasms, Desmoplastic Small Round Cell Tumor, Malignant Solitary Fibrous Tumors, Alveolar Soft Part Sarcoma, Epithelioid Hemangioendothelioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 30 May 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.
This trial is a translational, open-label, multi-sites, prospective and retrospective cohort study of 500 patients aimed at clinical and biological characterization of sarcoma of rare subtype.
400 patients will be included in this prospective cohort study; they will be identified in the investigating centers in the context of either routine care or a clinical study protocol.
Retrospective cases of patients (100 cases in total) will be identified in all centers through the GSF/GETO clinical databases already setted up (including the clinical base Conticabase).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Soft Tissue Sarcoma (Prospective cohort) | Other | Other: Patient with Soft Tissue Sarcoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥18 years at the time of study entry.
- Diagnosis of one of the following rare sarcoma subtype, confirmed by RRePS network:
- Localized/locally advanced or metastatic disease.
- In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision).
- In case of metastatic disease, project of new line of systemic treatment must have been decided before inclusion.
Key exclusion criteria (6 listed)
- Diagnosis of all other histotypes of soft tissue sarcoma.
- Any condition contraindicated with procedures required by the protocol.
- Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
- Pregnant or breast-feeding woman.
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 |
|---|---|---|
| Patient with Soft Tissue Sarcoma* Tumor specimens will be collected for the study at diagnosis. * A blood sample will be collected in all included patients at baseline, after the completion of the treatment (for patients included with a localized disease) or at the time of the first tumoral evaluation (for patients included with a metastatic disease), and at the time of progression. * Patient's data (clinical, biological and disease data) will also be collected at baseline visit and then at each time point planned in the center for clinical benefit assessment (i.e. every 2 or 3 months) until progression or for a maximum duration of 5 years. | Other | Patient with Soft Tissue Sarcoma (Prospective cohort) |
Primary outcome
Metastasis-free survival for patients with localized disease.
Time frame: 60 months for each patients
Progression-free survival for patients with metastatic disease.
Time frame: 60 months for each patients
3 secondary outcomes
Cancer-Testis Antigens (CTA) expression.
Time frame: 60 months for each patients
The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature.
Time frame: 60 months for each patients
Overall survival.
Time frame: 60 months for each patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient with Soft Tissue Sarcoma in people with Soft Tissue Sarcoma and Clear Cell Sarcoma, run by Institut Claudius Regaud at 20 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 20 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thibaud VALENTIN (+33 (0)5 31 15 51 70, Valentin.Thibaud@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastasis-free survival for patients with localized disease. (time frame: 60 months for each patients). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2026.