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Recruiting

NCT Number: NCT06782451

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Antoine Lacassagne

Nice, 06189, France

Location status: Recruiting

Location contact

Esma SAADA-BOUZID

PRINCIPAL_INVESTIGATOR

Study coordinator

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery or biopsy

Procedure

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

38 mL of blood will be taken for the study.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Obtain spheroids that are phenotypically and genotypically stable.

    Time frame: 1 month

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

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

    Time frame: 1 month

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

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

    Time frame: 1 month

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

Study contacts

Contact information is provided by the study sponsor or research team.

Study coordinator

CONTACT

[email protected]

+33 04 92 03 14 76 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Acronym: DST

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jan 17, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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