Clinical trial NCT06782451: Development of Preclinical Models Derived From Tumors With a Molecular Abnormality of Interest to Test Their Sensitivity to New Anti-tumor Therapies.
Official title: Development of Preclinical Models Derived From Tumors With a Molecular Abnormality of Interest to Test Their Sensitivity to New Anti-tumor Therapies.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasm Malignant
Keywords: Spheroids
Preclinic models
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 Criteria:

* 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.
* 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 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 the procedure,
  * 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 no possibility 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 \>50 mL/min or 3-5 days if CrCL \<50 mL/min before the procedure.
* Patient considered vulnerable; vulnerable persons are defined in articles L1121-5 to L1121-8:

  * 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. 3213-1 who do not fall under the provisions of article L. 1121-8, and individuals admitted to a healthcare or social facility for reasons other than research,
  * Adults under legal protection or unable to express their consent.

Primary outcomes:
measure: Development of a cell culture technique for spheroids derived from fresh tumor samples collected among patients carrying a mutation of interest.
timeFrame: 1 month
Secondary outcomes:
measure: Obtain spheroids that are phenotypically and genotypically stable.
timeFrame: 1 month
measure: Validate preclinical models to study the tumor response to innovative therapies.
timeFrame: 1 month
measure: Test the efficacy of molecules targeting variations identified in these tumors.
timeFrame: 1 month
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
References: