Multimodal Immune Characterization of RAre Soft Tissue Sa... | NCT03967834

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

NCT03967834

Sponsor

Institut Claudius Regaud

Status

Recruiting

Last Update Posted

Feb 10, 2026Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

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

Interventions

Patient with Soft Tissue Sarcoma

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 26, 2021Actual

Primary Completion Date

Apr 2031Estimated

Completion Date

Apr 2031Estimated

First Submitted Date

May 27, 2019

First Submission Date that Met QC Criteria

May 27, 2019

First Posted Date

May 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2026

Last Update Posted Date

Feb 10, 2026Actual

Description Module

Brief 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).

Detailed Description

Not provided

Conditions Module

Conditions

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with Soft Tissue Sarcoma (Prospective cohort)	Other		Other: Patient with Soft Tissue Sarcoma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patient with Soft Tissue Sarcoma	Other	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.

Measure	Description	Time Frame
Metastasis-free survival for patients with localized disease.		60 months for each patients
Progression-free survival for patients with metastatic disease.		60 months for each patients

Measure	Description	Time Frame
Cancer-Testis Antigens (CTA) expression.		60 months for each patients
The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature.		60 months for each patients

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)
- 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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

ID	Term
D012509	Sarcoma
D018227	Sarcoma, Clear Cell
D054973	Perivascular Epithelioid Cell Neoplasms
D058405	Desmoplastic Small Round Cell Tumor
D018234	Sarcoma, Alveolar Soft Part
D018323	Hemangioendothelioma, Epithelioid

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009372	Neoplasms, Connective Tissue
D009379	Neoplasms, Muscle Tissue
D006390	Hemangioendothelioma
D006391	Hemangioma
D009383	Neoplasms, Vascular Tissue