Clinical trial · Interventional
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 )
NCT02789384CI-TRIAL-00098196NEOSarcomicsrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft-tissue Sarcomas | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Procedure/Surgery | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Procedure/Surgery
- description
- Newly obtained biopsy if applicable and blood samples collection according to the usual medical practices.
- interventionNames
- Other: Procedure/Surgery
Primary outcomes (1)
- measure
- Assessment of antitumor activity of neoadjuvant anthracycline based chemotherapy. Efficacy will be defined based on complete response, partial response and stable disease observed during treatment following RECIST v1.1 criteria.
- timeFrame
- participants will be followed for the duration of treatment, an expected average of 6-months
Secondary outcomes (8)
- measure
- Efficacy of neoadjuvant anthracycline based chemotherapy in terms of proportion of tumour cells identified on the surgical specimen
- timeFrame
- an expected average of 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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, 2. Available archived frozen tumor tissue sample or patient consenting to undergo a biopsy of the tumour for research purpose, 3. 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, 4. Age ≥ 18 years, 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1, 6. Measurable disease according to RECIST v1.1 outside any previously irradiated field, 7. 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, 8. 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, 9. Voluntarily signed and dated written informed consents prior to any study specific procedure, 10. Patients with a social security in compliance with the French Law relating to biomedical research (Article 1121-11 of French Public Health Code). Exclusion Criteria: 1. Pathological diagnosis different from a soft-tissue sarcoma, 2. Histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, rhabdomyosarcoma, 3. Previous treatment for the sarcoma, 4. Contra-indication precluding the administration of chemotherapy as assessed by the investigator, 5. Participation to a study involving a medical or therapeutic intervention in the last 30 days, 6. Previous enrolment in the present study, 7. Pregnant or breast feeding women, 8. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.
References
Publications (1)
- DERIVEDGuegan JP, El Ghazzi N, Vibert J, Rey C, Vanhersecke L, Coindre JM, Toulmonde M, Spalato Ceruso M, Peyraud F, Bessede A, Italiano A. Predictive value of tumor microenvironment on pathologic response to neoadjuvant chemotherapy in patients with undifferentiated pleomorphic sarcomas. J Hematol Oncol. 2024 Oct 23;17(1):100. doi: 10.1186/s13045-024-01614-w. PMID 39444039