Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807516
Status:
RECRUITING
Last Update Posted:
2023-04-25
First Post:
2023-03-29
Brief Title:
Single-cell RNAseq Breast Cancer
Sponsor:
Regina Elena Cancer Institute
Organization:
Regina Elena Cancer Institute
Study Overview
Official Title:
Study of the Impact of Neoadjuvant Therapy on the Heterogeneity of Triple Negative Breast Cancer Through Single-cell RNA Sequencing scRNAseq and Whole-exome Sequencing WES
Status:
RECRUITING
Status Verified Date:
2023-03
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:
SCRBC
Brief Summary:
Molecular characterization of persistent tumor cells remaining after NAC and infiltrating immune cells for example M2 macrophages could strongly contribute to identifying targeted therapeutic approaches for this disease
Detailed Description:
Triple negative breast cancer TNBC represents approximately 15-20 of all breast cancers Its features are lack of expression of estrogen receptor ER progesterone receptor PR and human epidermal growth factor receptor 2 Her2 TNBC exhibits a biologically aggressive behavior and a high inter- and intra-tumor molecular heterogeneity which has recently been highlighted also in single cell RNAseq scRNAseq studies Patients with TNBC often have less positive outcomes then other breast cancer subtypes due to the absence of specific therapeutic targets
Results of single cell RNA sequencing scRNAseq in TNBC before and after treatment with chemotherapy NAC were recently reported for a small group of patients Genetic alterations are also investigated by Whole Exome Sequencing WES
In addition scRNAseq analysis confirmed the presence of a high percentage of M2 macrophages in TNBC and tumor-adjacent tissue These macrophages are clinically relevant and able to predict outcome in TNBC
Based on the above evidence we hypothesize that molecular characterization of persistent tumor cells remaining after NAC and infiltrating immune cells for example M2 macrophages could strongly contribute to identifying targeted therapeutic approaches for this disease
We will conduct a pilot study with a combined retrospective and prospective observational design
Cancer patients diagnosed with histologically proven primary invasive breast cancer with a stage IIA to IIIB and assessed at the molecular level and defined as TNBC will be eligible to participate to the study Furthermore only patients with a tumor 15cm in size will be considered which is the selection criterion for the administration of neoadjuvant therapy
Results of single cell RNA sequencing scRNAseq in TNBC before and after treatment with chemotherapy NAC were recently reported for a small group of patients Genetic alterations are also investigated by Whole Exome Sequencing WES
In addition scRNAseq analysis confirmed the presence of a high percentage of M2 macrophages in TNBC and tumor-adjacent tissue These macrophages are clinically relevant and able to predict outcome in TNBC
Based on the above evidence we hypothesize that molecular characterization of persistent tumor cells remaining after NAC and infiltrating immune cells for example M2 macrophages could strongly contribute to identifying targeted therapeutic approaches for this disease
We will conduct a pilot study with a combined retrospective and prospective observational design
Cancer patients diagnosed with histologically proven primary invasive breast cancer with a stage IIA to IIIB and assessed at the molecular level and defined as TNBC will be eligible to participate to the study Furthermore only patients with a tumor 15cm in size will be considered which is the selection criterion for the administration of neoadjuvant therapy
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