BridgeMD
New treatment option for Soft Tissue Sarcoma
Official title Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
ClinicalTrials.gov ID: NCT03967834
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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...
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of...
- Pregnant or breast-feeding woman.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Bordeaux, France
- Clermont-Ferrand, France
- Dijon, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Nice, France
- Paris, France
- Poitiers, France
- Reims, France
- Rennes, France
- Saint-Herblain, France
- Strasbourg, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Bordeaux, France; Clermont-Ferrand, France; Dijon, France; Lille, France; Limoges, France and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.