Development of Preclinical Models Derived From Tumors With a Molecular Abnormality of Interest to Test Their Sensitivity to New Anti-tumor Therapies.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgery or biopsy, Blood sample.
- Who it may be relevant to
- Registry conditions: Neoplasm Malignant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Surgery or biopsy
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. - Procedure Blood sample
38 mL of blood will be taken for the study.
Primary outcome measures
- Development of a cell culture technique for spheroids derived from fresh tumor samples collected among patients carrying a mutation of interest. [Time frame: 1 month]
Secondary outcome measures (3)
- Obtain spheroids that are phenotypically and genotypically stable. [Time frame: 1 month]
- Validate preclinical models to study the tumor response to innovative therapies. [Time frame: 1 month]
- Test the efficacy of molecules targeting variations identified in these tumors. [Time frame: 1 month]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Centre Antoine Lacassagne — Nice
Identifiers
NCT: NCT06782451 · 2023/57 · 2024-A01616-41