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

Sponsor

Institut Claudius Regaud (Other)

Overall Status

Recruiting

CT.gov ID

NCT03967834

Collaborator

(none)

400

Enrollment

Locations

Arm

16.2

Anticipated Duration (Months)

30.8

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
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	Other: Patient with Soft Tissue Sarcoma	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 26, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Patient with Soft Tissue Sarcoma (Prospective cohort)	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.

Arm

Intervention/Treatment

Other: Patient with Soft Tissue Sarcoma (Prospective cohort)

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.

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]
Overall survival. [60 months for each patients]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Chu Besancon - Site Jean Minjoz	Besancon	France	25000
2	Centre Jean Perrin	Clermont-Ferrand	France	63011
3	Centre Oscar Lambret	Lille	France	59020
4	Centre Leon Berard	Lyon	France	69008
5	Institut Paoli-Calmettes	Marseille	France	13009
6	Chu de Marseille - Hopital de La Timone	Marseille	France
7	Centre Antoine Lacassagne	Nice	France	06189
8	Centre Eugene Marquis	Rennes	France
9	Institut de Cancerologie de L'Ouest - Site Rene Gauducheau	Saint-Herblain	France	44805
10	Institut de Cancérologie Strasbourg Europe	Strasbourg	France
11	Institut Universitaire du Cancer Toulouse - Oncopole	Toulouse	France
12	Institut de Cancerologie de Lorraine	Vandoeuvre-les-nancy	France	54519
13	Institut Gustave Roussy	Villejuif	France	94805