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

Soft Tissue Sarcoma Clinical Trial

— MIRAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03967834
• Other study ID #: 19 SARC 04
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: April 2031

Study information

• Verified date: September 2023
• Source: Institut Claudius Regaud
• Contact: Thibaud VALENTIN
• Phone: +33 (0)5 31 15 51 70
• Email: Valentin.Thibaud[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2031
• Est. primary completion date: April 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 metastatic 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 line of systemic treatment 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 RECIST 1.1) or not.

9. ECOG Performance status 0-3.

10. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.

11. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Diagnosis of all other histotypes of soft tissue sarcoma.

2. Any condition contraindicated with procedures required by the protocol.

3. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (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 informed consent 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.

Related Conditions & MeSH terms

• Alveolar Soft Part Sarcoma
• Clear Cell Sarcoma
• Desmoplastic Small Round Cell Tumor
• Epithelioid Hemangioendothelioma
• Epithelioid Sarcoma
• Fibrosarcoma
• Hemangioendothelioma
• Hemangiopericytoma
• Low Grade Fibromyxoid Sarcoma
• Malignant Solitary Fibrous Tumors
• Neoplasms
• Perivascular Epithelioid Cell Neoplasms
• Sarcoma
• Sarcoma, Alveolar Soft Part
• Sarcoma, Clear Cell
• Sclerosing Epithelioid Fibrosarcoma
• Soft Tissue Sarcoma
• Solitary Fibrous Tumors

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Chu Besancon - Site Jean Minjoz	Besancon
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Oscar Lambret	Lille
France	Chu Dupuytren	Limoges
France	Centre Leon Berard	Lyon
France	Chu de Marseille - Hopital de La Timone	Marseille
France	Institut Paoli-Calmettes	Marseille
France	Centre Antoine Lacassagne	Nice
France	Hôpital Cochin - Site Port-Royal	Paris
France	Institut Curie	Paris
France	Chu Poitiers	Poitiers
France	Institut Godinot	Reims
France	Centre Eugene Marquis	Rennes
France	Institut de Cancerologie de L'Ouest - Site Rene Gauducheau	Saint-Herblain
France	Institut de Cancérologie Strasbourg Europe	Strasbourg
France	Institut Universitaire du Cancer Toulouse - Oncopole	Toulouse
France	Institut de Cancerologie de Lorraine	Vandoeuvre-les-nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metastasis-free survival for patients with localized disease.		60 months for each patients
Primary	Progression-free survival for patients with metastatic disease.		60 months for each patients
Secondary	Cancer-Testis Antigens (CTA) expression.		60 months for each patients
Secondary	The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature.		60 months for each patients
Secondary	Overall survival.		60 months for each patients