Development of Preclinical Models Derived From Tumors With a Molecular Abnormality of Interest to Test Their Sensitivity to New Anti-tumor Therapies.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Antoine Lacassagne

About this trial

This study aims to collect tumor samples from patients carrying a mutation of interest to develop a cell culture technique for "spheroids.

The goal is to use these spheroids to model responses to anticancer treatments. Various therapeutic molecules can be tested on these spheroids, enabling the evaluation of the potential of new molecules or the activity of existing ones specifically on the tumor (bearing the mutation of interest) from which the spheroid was developed.

Tumor samples will be collected as part of biopsies or surgeries conducted during routine patient care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

Patient for whom at least one mutation deemed of interest by the investigator has been identified.

Patient with a malignant tumor at a locally advanced or metastatic stage, for whom a tissue tumor sample (via surgery, radiology, or endoscopy) is scheduled as part of their standard care.

Tumor volume deemed sufficient by the physician to ensure an adequate amount of material for analysis by the pathologist and the transfer of a part of the tumor sample to the Laboratory of Translational Research in Oncology for the study.

Disqualifiers

Patient with multiple primary malignant tumors.

Patient with a known HIV, Hepatitis C, or Hepatitis B infection.

Clopidogrel (hydrogensulfate) or Prasugrel (hydrochloride) or Ticlopidine (hydrochloride) with no possibility of suspension for 5 days,

Low molecular weight heparin with no possibility of dose suspension before the procedure,

Trial design

Design model

Single group

Treatments tested in this trial

  • Surgery or biopsy

    Procedure/Surgery

    A part of the tumor sample collected during the surgery or the biopsy performed as part of routine patient care will be used for the research.

  • Blood sample

    Procedure/Surgery

    38 mL of blood will be taken for the study.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: ExperimentalExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Development of a cell culture technique for spheroids derived from fresh tumor samples collected among patients carrying a mutation of interest.

The primary evaluation criterion is the percentage of patients for whom viable spheroids were obtained from tumors with a molecular abnormality of interest, measured by cell viability one month after the tumor sample was collected.

Time frame
1 month

Secondary outcomes

1

Obtain spheroids that are phenotypically and genotypically stable.

The phenotypic and genotypic stability of spheroids over time will be assessed using molecular characterization techniques (e.g., immunohistochemistry, sequencing).

Time frame
1 month
2

Validate preclinical models to study the tumor response to innovative therapies.

The ability of spheroids to mimic aspects of the tumor microenvironment, such as hypoxia and extracellular matrix formation, will be evaluated.

Time frame
1 month
3

Test the efficacy of molecules targeting variations identified in these tumors.

The response of the spheroids to specific anti-tumor therapies will be evaluated through drug sensitivity tests (e.g., cytotoxicity assays).

Time frame
1 month

Other outcomes

Sponsors and contacts

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