NCT02789384

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 )

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (estimated)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Even when retrospective statistical identification for a biomarker has been achieved, the ultimate proof of its usefulness in the clinic still requires prospective evidence. Our prospective study aims to validate the prognosis value of the CINSARC signature in a prospective way. Moreover, the neoadjuvant setting is an ideal one to identify molecular predictive factors of sensitivity to chemotherapy by correlating tumor response with genetic profile of STS. Moreover, molecular profiling of treatment-refractory tumor cells may reveal alterations that are associated with drug resistance, metastatic recurrence and disease progression. The identifications of such factors in the neoadjuvant setting may help to improve the management of STS patients in the adjuvant and metastatic settings

Conditions

• Soft-tissue Sarcomas

Interventions

Type	Name	Description
OTHER	Procedure/Surgery	Procedure/Surgery: Newly obtained biopsy if applicable and Blood samples collection. For each patient: * Frozen and paraffin embedded tumor material (archival or new biopsy) will be obtained for genetic profiling * Blood samples will be obtained for genetic profiling and assessment of markers. The classification as CINSARC will be performed for each patient. Patients should be treated by neoadjuvant anthracycline-based chemotherapy. Chemotherapy regimen must contain at least doxorubicin (dose range: 60 -75 mg/m²) and ifosfamide (dose range: 2.5-3g/m²) to be delivered on a 21-days cycle basis up to 6 cycles prior surgery. After neoadjuvant chemotherapy completion, patients will be treated by surgery followed or not by radiotherapy. All patients should be managed according to the usual medical practices.

Timeline

• Start date: 2016-06-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2016-06-03
• Last updated: 2025-12-02

Locations

10 sites across 1 country: France