CINSARC Signature and Correlation With Hemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. (NEOSarcomics)

November 24, 2025 updated by: Institut Bergonié

Prognostic Value of the CINSARC (Complexity Index in Sarcoma) Signature and Correlation With Chemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. (NEOSarcomics )

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

205

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33076
      • Dijon, France, 21079
        • Recruiting
        • Centre Georges Francois Leclerc
        • Contact:
          • Nicolas ISAMBERT
        • Principal Investigator:
          • ISAMBERT Nicolas, MD
      • Lille, France, 59020
        • Not yet recruiting
        • Centre Oscar Lambret
        • Principal Investigator:
          • PENEL Nicolas, MD
      • Lyon, France, 69373
      • Marseille, France, 13273
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
        • Principal Investigator:
          • BERTUCCI François, MD,PhD
      • Marseille, France, 13385
        • Recruiting
        • AP-HM _ Hôpital de la Timone
        • Contact:
        • Principal Investigator:
          • DUFFAUD Florence, MD,PhD
      • Nantes, France, 44805
      • Paris, France, 75005
        • Not yet recruiting
        • Institut Curie
        • Principal Investigator:
          • PIPERNO-NEUMANN Sophie, MD
      • Toulouse, France, 31052
      • Villejuif, France, 94805
        • Not yet recruiting
        • Institut Gustave Roussy
        • Principal Investigator:
          • LECESNE Axel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Procedure/Surgery
Newly obtained biopsy if applicable and blood samples collection according to the usual medical practices.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: participants will be followed for the duration of treatment, an expected average of 6-months
participants will be followed for the duration of treatment, an expected average of 6-months

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy of neoadjuvant anthracycline based chemotherapy in terms of proportion of tumour cells identified on the surgical specimen
Time Frame: an expected average of 6 months
an expected average of 6 months
Association of the CINSARC signature and histological response based on the proportion of tumour cells identified on the surgical specimen
Time Frame: an expected average of 6 months
an expected average of 6 months
Patient's classification by CINSARC signature. Patients will be classified as either low risk CINSARC or high risk
Time Frame: 6 months
6 months
Metastasis-free survial is defined following recent guidelines for the definition of survival endpoints in sarcoma trials (Bellera et al. Annals Oncol 2014.
Time Frame: 3 years
3 years
3 -year Overall Survial (OS) defined as the time from study treatment initiation to death (of any cause).
Time Frame: 3 years
3 years
Histological response is defined using both 3 histological parameters: proportion of recognizable tumor cells, fibrosis and necrosis in the surgical specimen.
Time Frame: an expected average of 6 months
an expected average of 6 months
Identification of molecular mechanisms involved in intrinsic resistance to chemotherapy by correlating the transcriptome data with response to chemotherapy.
Time Frame: an expected average of 6 months
an expected average of 6 months
Adverse events related to the biopsy procedure will be graded using the common toxicity criteria from the NCI v4.0.
Time Frame: during 7 days after biopsy
during 7 days after biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Collaborators

Ministry of Health, France
National Cancer Institute, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 29, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimated)

June 3, 2016

Study Record Updates

Last Update Posted (Estimated)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB 2015-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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