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 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
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
Trial sites (20)
Facility
City
Region
Status
Chu Besancon - Site Jean Minjoz
Besançon
France
Recruiting
Institut Bergonié
Bordeaux
France
Recruiting
Centre Jean Perrin
Clermont-Ferrand
France
Recruiting
Centre Georges François Leclerc
Dijon
France
Not Yet Recruiting
Centre Oscar Lambret
Lille
France
Recruiting
Chu Dupuytren
Limoges
France
Recruiting
Centre Leon Berard
Lyon
France
Recruiting
Institut Paoli-Calmettes
Marseille
France
Withdrawn
Chu de Marseille - Hopital de La Timone
Marseille
France
Recruiting
Centre Antoine Lacassagne
Nice
France
Recruiting
Hôpital Cochin - Site Port-Royal
Paris
France
Recruiting
Institut Curie
Paris
France
Recruiting
Chu Poitiers
Poitiers
France
Recruiting
Institut Godinot
Reims
France
Recruiting
Centre Eugene Marquis
Rennes
France
Recruiting
Institut de Cancerologie de L'Ouest - Site Rene Gauducheau
Saint-Herblain
France
Withdrawn
Hôpitaux Universitaires de Strasbourg
Strasbourg
France
Recruiting
Institut Universitaire du Cancer Toulouse - Oncopole
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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