RecruitingNCT05404321

Establishment of an ex Vivo Tumor Collection of Triple-negative Breast Cancers in Order to Validate the Interest of Innovative Therapies and the Search for Predictive Biomarkers of Response to Treatment


Sponsor

Centre Francois Baclesse

Enrollment

163 participants

Start Date

Jan 9, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Initially described in 2009 on LGR5 positive stem cells from intestine, organoids correspond to a 3D cell culture that preserves the organization and part of the initial function of the organ from which the cells were derived. They use the proliferation and differentiation properties of stem cells cultured in a three-dimensional matrix. These principles have been adapted to many human organs, including the breast. These culture conditions have thus allowed the establishment of cancer organoid lines that have the advantages of rapid amplification, a high rate of establishment success and unlimited proliferation potential. They are transfectable and cryopreservable. They are very close morphologically and genetically to the tumor from which they derive. Very recently, the in vivo response of orthotopic xenograft models of breast cancer organoids has been correlated to the in vitro response of these same organoids. In addition, the in vitro response of various of these models to PARP inhibitors was linked to the presence of the BRCA1/2 mutant signature, highlighting the potential of these models to predict patient response to these treatments. Furthermore, one study demonstrated the value of using organoids derived from metastatic gastrointestinal tumors to predict patient response to cancer treatments (100% sensitivity, 93% specificity, 88% positive predictive value, and 100% negative predictive value.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting tumor tissue from women with triple-negative breast cancer who are receiving chemotherapy before surgery, to grow lab models of the tumor (called organoids) and identify new markers that predict how well a treatment will work. **You may be eligible if...** - You are a woman over 18 years old - You have been diagnosed with early-stage (Stage I–III) triple-negative breast cancer - You need to have a clip placed in your tumor before starting neoadjuvant (pre-surgery) chemotherapy - You are fluent in French - You are covered by a social security system **You may NOT be eligible if...** - You are pregnant - You are legally protected or deprived of liberty - You have a condition preventing safe biopsy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREstablishment of ex vivo breast cancer organoid models

This study includes 2 steps: The constitution of a collection of tumor and blood samples and the analysis of the ex vivo response of the tumor samples to the treatments for the development of functional tests and the research of predictive biomarkers of this response


Locations(1)

Centre François Baclesse

Caen, France

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NCT05404321


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