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Can a simple test predict who will respond to this sarcoma drug?

NCT ID NCT04008238

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 aims to find biological markers that can predict whether the drug trabectedin will work in patients with certain types of soft-tissue sarcoma. Researchers will collect tumor biopsies and blood samples from 29 participants before and during treatment. The goal is to use advanced testing to identify which patients are most likely to benefit, potentially leading to more personalized treatment decisions.

What this could mean

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

Active substance
trabectedin
What this could lead to
If successful, this could help doctors identify which sarcoma patients are most likely to benefit from trabectedin, making treatment more personalized.
What could go wrong
This is a small, early-stage study focused on finding biomarkers, not on proving treatment effectiveness. The results may not apply to all sarcoma types or lead to immediate changes in care.

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

29 people

The number who actually took part.

Started

Jan 2020

Finished

Aug 2024

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. Age ≥ 18 years, 2. Histology: undifferentiated pleomorphic sarcomas, epithelioid sarcomas, solitary fibrous tumors, hemangioendothelioma, desmoplastic round cell tumors, synovial sarcomas or other non-leiomyosarcoma/non-liposarcoma softtissue sarcoma. As per the Frech NCI recommendation, diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de Référence en Pathologie des Sarcomes des tissus mous et des Viscères), 3. Locally advanced/unresectable and/or metastatic disease, 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix 1), 5. Measurable disease according to RECIST v1.1, 6. Indication of trabectedin according to market authorization, 7. At least one target lesion that can be biopsied for research, 8. Women of childbearing potential must have a negative serum pregnancy test before study entry, 9. Patient with a social security in compliance with the French law, 10. Voluntary signed and dated written informed consent prior to any study specific procedure, 11. Women must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of trabectedin. Men must agree to use a medically acceptable method of contraception throughout the treatment period and for 5 months after discontinuation of trabectedin. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>=1 year. Exclusion Criteria: 1. Previous treatment with trabectedin, 2. Known hypersensitivity to any of its components, 3. Patients with an active serious or uncontrolled infection upon investigator judgement, 4. Radiological evidence of symptomatic or progressive brain metastases, 5. Abnormal coagulation contraindicating biopsy, 6. Any medical and/or biological contra-indication to treatment by trabectedin as per market authorization specification (as per investigator judgement), 7. Patients unable to receive corticotherapy, 8. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer, 9. Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV), 10. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol, 11. Individuals deprived of liberty or placed under guardianship, 12. Pregnant or breast feeding women, 13. Previous enrolment in the present study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Institut Bergonie

    Bordeaux, 33076, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.