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

Last updated: May 5, 2025
Sponsor: Centre Antoine Lacassagne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Treatment

Surgery or biopsy

Blood sample

Clinical Study ID

NCT06782451
2023/57
2024-A01616-41
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Age 18 years or older.

  • Patient for whom at least one mutation deemed of interest by the investigator hasbeen identified.

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

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

  • INR < 1.5; Platelets < 50,000/μL.

  • Patient who has been informed of the study and has signed the informed consent form.

  • Patient affiliated with a social security insurance.

Exclusion

Exclusion Criteria:

  • Patient with multiple primary malignant tumors.

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

  • Patient on:

  • 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 theprocedure,

  • Fondaparinux with no possibility of suspension,

  • Abciximab with no possibility of suspension for 24 hours and aPTT < 50s and ACT < 150s,

  • Eptifibatide or Tirofiban Hydrochloride Monohydrate or Argatroban with nopossibility of suspension 4 hours before the procedure,

  • Bivalirudin with no possibility of suspension 2-3 hours if CrCL >50 mL/min or 3-5 hours if CrCL <50 mL/min before the procedure,

  • Dabigatran etexilate with no possibility of suspension 2-3 days if CrCL >50mL/min or 3-5 days if CrCL <50 mL/min before the procedure.

  • Patient considered vulnerable; vulnerable persons are defined in articles L1121-5 toL1121-8:

  • Pregnant women, parturients, and breastfeeding mothers,

  • Individuals deprived of their liberty by a judicial or administrative decision,individuals hospitalized without consent under articles L. 3212-1 and L. 3213-1who do not fall under the provisions of article L. 1121-8, and individualsadmitted to a healthcare or social facility for reasons other than research,

  • Adults under legal protection or unable to express their consent.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Surgery or biopsy
Phase:
Study Start date:
May 02, 2025
Estimated Completion Date:
July 02, 2030

Connect with a study center

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Active - Recruiting

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