Ignite Creation Date:
2024-05-06 @ 5:43 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05404321
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2022-05-31
Brief Title:
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
Organization:
Centre Francois Baclesse
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIPLEX
Brief 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 BRCA12 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
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 BRCA12 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None