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出境医 / 临床实验 / Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group (MIRAS)

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

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 Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 26, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022
Arms and Interventions
Arm Intervention/treatment
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 :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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

Locations
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France
Chu Besancon - Site Jean Minjoz Not yet recruiting
Besancon, France, 25000
Contact: Guillaume MEYNARD    03 70 63 24 03    gmeynard@chu-besancon.fr   
Centre Jean Perrin Recruiting
Clermont-Ferrand, France, 63011
Contact: Pascale DUBRAY-LONGERAS    04 73 27 81 41    pascale.dubray-longeras@clermont.unicancer.fr   
Centre Oscar Lambret Not yet recruiting
Lille, France, 59020
Contact: Nicolas PENEL    03 20 29 59 59    n-penel@o-lambret.fr   
Centre Leon Berard Not yet recruiting
Lyon, France, 69008
Contact: Armelle DUFRESNE    04 69 85 61 47    armelle.dufresne@lyon.unicancer.fr   
Institut Paoli-Calmettes Not yet recruiting
Marseille, France, 13009
Contact: François BERTUCCI    04 91 22 35 37    bertuccif@ipc.unicancer.fr   
Institut de Cancerologie de L'Ouest - Site Rene Gauducheau Not yet recruiting
Saint-Herblain, France, 44805
Contact: Emmanuelle BOMPAS    02 40 67 99 39    emmanuelle.bompas@ico.unicancer.fr   
Institut Universitaire du Cancer Toulouse - Oncopole Recruiting
Toulouse, France
Contact: Thibaud VALENTIN    +33 (0)5 31 15 51 70    Valentin.Thibaud@iuct-oncopole.fr   
Institut de Cancerologie de Lorraine Not yet recruiting
Vandoeuvre-les-nancy, France, 54519
Contact: Maria RIOS    03 83 59 84 61    m.rios@nancy.unicancer.fr   
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Contact: Olivier MIR    01 42 11 61 35    olivier.mir@gustaveroussy.fr   
Sponsors and Collaborators
Institut Claudius Regaud
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date April 27, 2021
Actual Study Start Date  ICMJE April 26, 2021
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2021)
  • Metastasis-free survival for patients with localized disease. [ Time Frame: 60 months for each patients ]
  • Progression-free survival for patients with metastatic disease. [ Time Frame: 60 months for each patients ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019) 		Cancer-Testis Antigens (CTA) expression [ Time Frame: 36 months for all patients ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2021)
  • Cancer-Testis Antigens (CTA) expression. [ Time Frame: 60 months for each patients ]
  • The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature. [ Time Frame: 60 months for each patients ]
  • Overall survival. [ Time Frame: 60 months for each patients ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019) 		The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature [ Time Frame: 36 months for all patients ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
Official Title  ICMJE Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • 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
Intervention  ICMJE 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.
Study Arms  ICMJE Patient with Soft Tissue Sarcoma (Prospective cohort)
Intervention: Other: Patient with Soft Tissue Sarcoma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 16, 2021) 		400
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2019) 		500
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thibaud VALENTIN +33 (0)5 31 15 51 70 Valentin.Thibaud@iuct-oncopole.fr
Contact: Frédéric CHIBON +33 (0)5 82 74 17 65 frederic.chibon@inserm.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03967834
Other Study ID Numbers  ICMJE 19 SARC 04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Claudius Regaud
Study Sponsor  ICMJE Institut Claudius Regaud
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut Claudius Regaud
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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