NCT02789384Recruiting
CINSARC Signature and Correlation With Hemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study.
Prognostic Value of the CINSARC (Complexity Index in Sarcoma) Signature and Correlation With Chemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. (NEOSarcomics )
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
This is a prospective observational biomarker study including patients with non-metastatic, soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best option by the multidisciplinary sarcoma team of one of the participating centers.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 205 (estimated)
- First submitted
- 29 Apr 2016
- Start date
- Jun 2016
- Primary completion date
- Dec 2026
- Lead sponsor
- Institut Bergonié
- Diseases
- Sarcoma
- NCT number
- NCT02789384
What you commit to
- Study type: Interventional
- Planned participants: 205
- From Jun 2016 to the primary completion date, Dec 2026
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment for the sarcoma,
- Contra-indication precluding the administration of chemotherapy as assessed by the investigator,
- Previous enrolment in the present study,
Other
- Pathological diagnosis different from a soft-tissue sarcoma,
- Histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, rhabdomyosarcoma,
- Participation to a study involving a medical or therapeutic intervention in the last 30 days,
- Pregnant or breast feeding women,
- Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.
Who the study is looking for
- Histologically confirmed soft-tissue sarcoma by central review, except if the diagnosis was already confirmed by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) Network,
- Available archived frozen tumor tissue sample or patient consenting to undergo a biopsy of the tumour for research purpose,
- Non-metastatic disease, for which the use of chemotherapy to "downstage" the sarcoma prior to surgery, is assumed to result in better local tumor control by the multidisciplinary sarcoma team of one of the French reference centers involved in this study,
- Age ≥ 18 years,
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,
- Measurable disease according to RECIST v1.1 outside any previously irradiated field,
- Neoadjuvant anthracycline-based chemotherapy proposed as the best option by the multidisciplinary sarcoma team of one of the French reference centers involved in this study,
- No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,
- Voluntarily signed and dated written informed consents prior to any study specific procedure,
- Patients with a social security in compliance with the French Law relating to biomedical research (Article 1121-11 of French Public Health Code).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| AP-HM - Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Institut de Cancérologie de l'Ouest Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Institut Claudius Regaud - IUCT-0 Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.