Clinical trial NCT03967834: Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
Official title: Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Metastasis-free survival for patients with localized disease.
timeFrame: 60 months for each patients
measure: Progression-free survival for patients with metastatic disease.
timeFrame: 60 months for each patients
Secondary outcomes:
measure: Cancer-Testis Antigens (CTA) expression.
timeFrame: 60 months for each patients
measure: The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature.
timeFrame: 60 months for each patients
measure: Overall survival.
timeFrame: 60 months for each patients
Other outcomes:
Locations:
city: Besancon
country: France
facility: Chu Besancon - Site Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonié
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: Chu Dupuytren
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Marseille
country: France
facility: Chu de Marseille - Hopital de La Timone
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Cochin - Site Port-Royal
city: Paris
country: France
facility: Institut Curie
city: Poitiers
country: France
facility: Chu Poitiers
city: Reims
country: France
facility: Institut Godinot
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de L'Ouest - Site Rene Gauducheau
city: Strasbourg
country: France
facility: Institut de Cancérologie Strasbourg Europe
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole
city: Vandoeuvre-les-nancy
country: France
facility: Institut de Cancerologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: