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Gene signature may forecast chemo response in sarcoma patients

NCT ID NCT02789384

Knowledge-focused Sponsor: Institut Bergonié Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a genetic test called CINSARC can predict how well chemotherapy works in people with soft-tissue sarcoma. Researchers will collect tumor and blood samples from 205 participants before they receive standard chemotherapy and surgery. The goal is to see if the CINSARC signature matches how the tumor responds, which could help personalize treatment in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors better predict which sarcoma patients will benefit from chemotherapy before surgery.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to immediate changes in care, and the genetic signature may not prove reliable enough for routine use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 205 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2016

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

sarcoma soft tissue sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Soft tissue sarcomas

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HM _ Hôpital de la Timone

    RECRUITING

    Marseille, 13385, France

  • Centre Georges François Leclerc

    RECRUITING

    Dijon, 21079, France

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69373, France

  • Centre Oscar Lambret

    NOT_YET_RECRUITING

    Lille, 59020, France

  • Institut Bergonié

    RECRUITING

    Bordeaux, 33076, France

  • Institut Claudius Regaud - IUCT-0

    RECRUITING

    Toulouse, 31052, France

  • Institut Curie

    NOT_YET_RECRUITING

    Paris, 75005, France

  • Institut Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, 94805, France

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, 13273, France

  • Institut de Cancérologie de l'Ouest

    RECRUITING

    Nantes, 44805, France

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