ClinicalTrials.gg
RecruitingNCT03967834MIRASUpdated Feb 10, 2026

Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group

An interventional study of Patient with Soft Tissue Sarcoma in Soft Tissue Sarcoma, Clear Cell Sarcoma and Epithelioid Sarcoma, sponsored by Institut Claudius Regaud. Recruiting at 20 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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).

02

Conditions studied

  • 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

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
03

In context

Sarcoma

1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.

This study's planned enrollment of 400 is above the median of 40 across 1,255 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 years at the time of study entry.
  2. 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)
    • Malignant Solitary Fibrous Tumours (mSFT)
    • Alveolar Soft Part Sarcoma (ASPS)
    • Epithelioid Hemangioendothelioma (EH)
    • Low-Grade Fibromyxoid Sarcoma (LGFS)
    • Sclerosing Epithelioid Fibrosarcoma (SEF).
  3. Localized/locally advanced or disease.
  4. In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision).
  5. In case of metastatic disease, project of new must have been decided before inclusion.
  6. Patient followed in the center within a standard of care procedure or clinical trial.
  7. Archived tumor specimen at initial diagnosis available (before treatment initiation).
  8. Evaluable disease (measurable as per 1.1) or not.
  9. Performance status 0-3.
  10. Patient able to participate and willing to give prior to performance of any study-related procedures.
  11. Patient affiliated to a Social Health Insurance in France.

Exclusion criteria

Exclusion Criteria:

  1. Diagnosis of all other histotypes of soft tissue sarcoma.
  2. Any condition with procedures required by the protocol.
  3. Known history of positive test for virus or virus or (HIV) or known acquired immunodeficiency syndrome (AIDS).
  4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of or compliance to study procedure.
  5. Pregnant or breast-feeding woman.
  6. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Other
    Patient with Soft Tissue Sarcoma (Prospective cohort)

    Other: Patient with Soft Tissue Sarcoma

Interventions

  • OtherPatient 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.

06

What researchers measure

Primary outcomes

  1. Metastasis-free survival for patients with localized disease.

    Time frame: 60 months for each patients

  2. Progression-free survival for patients with metastatic disease.

    Time frame: 60 months for each patients

Secondary outcomes

  1. Cancer-Testis Antigens (CTA) expression.

    Time frame: 60 months for each patients

  2. The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature.

    Time frame: 60 months for each patients

  3. Overall survival.

    Time frame: 60 months for each patients

07

Study locations

16 of 20 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2021 (actual). Primary completion is estimated for Apr 2031, 120 months after the start.

Of 144 non-industry interventional studies with no phase under Sarcoma, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 120. This study's planned 120 months is above that.

Counting every sponsor, half of 147 studies reached it within 59 months; a quarter within 34 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2019
First posted
May 30, 2019
StartActual
Apr 26, 2021
Primary completionEst.
Apr 2031
CompletionEst.
Apr 2031
Last update
Feb 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03967834
Responsible party
Sponsor
First posted
May 30, 2019
Start date
Apr 26, 2021
Primary completion
Apr 2031 (estimated)
Completion
Apr 2031 (estimated)
Last update
Feb 10, 2026

Study contacts

Thibaud VALENTIN
Contact
Valentin.Thibaud@iuct-oncopole.fr
+33 (0)5 31 15 51 70
Frédéric CHIBON
Contact
frederic.chibon@inserm.fr
+33 (0)5 82 74 17 65

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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