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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03967834
Other study ID # 19 SARC 04
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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