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RecruitingNCT06782451DSTUpdated Jul 20, 2026

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

An interventional study of Surgery or biopsy and Blood sample in Neoplasm Malignant, sponsored by Centre Antoine Lacassagne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Centre Antoine Lacassagne · Not applicable, Interventional, and Other

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Neoplasm Malignant

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Keywords

  • Spheroids
  • Preclinic models
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Centre Antoine Lacassagne is the lead sponsor of 66 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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.
  • \< 1.5; > 50,000/μL.
  • Patient who has been informed of the study and has signed the form.
  • Patient affiliated with a social security insurance.

Exclusion criteria

Exclusion Criteria:

  • Patient with multiple primary malignant tumors.
  • Patient with a known , , or 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 \< 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Experimental

    For this study, the included patients will have a biopsy or a surgery performed as part of routine patient care. A part of the tumor sample will be transmitted to the Laboratory of Translational Research in Oncology to develop spheroids. A blood sample will also be taken (38 mL) and analyzed by the Laboratory of Translational Research in Oncology in order to assess hematological toxicities of drugs and study a potential link between disease stage and the quantity of exosomes secreted.

    Procedure: Surgery or biopsy · Procedure: Blood sample

Interventions

  • ProcedureSurgery 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.

  • ProcedureBlood sample

    38 mL of blood will be taken for the study.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06782451
Lead sponsor
Centre Antoine Lacassagne
Responsible party
Sponsor
First posted
Jan 17, 2025
Start date
May 2, 2025
Primary completion
Jul 2, 2030 (estimated)
Completion
Jul 2, 2030 (estimated)
Last update
Jul 20, 2026

Study contacts

Study coordinator
Contact
DRCI-Promotion@nice.unicancer.fr
+33 04 92 03 14 76 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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