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Trial Title:
Single-cell RNAseq Breast Cancer
NCT ID:
NCT05807516
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Single-cell RNA sequencing (scRNAseq), whole-exome sequencing (WES)
Description:
Combined both retrospective and prospective observational design
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 >1.5cm in
size will be considered, which is the selection criterion for the administration of
neoadjuvant therapy.
Criteria for eligibility:
Study pop:
The retrospective study will be performed using only formalin-fixed paraffin-embedded
(FFPE) tissue samples for protein expression profiling (proteomics) from patients withthe
above inclusion/exclusion criteria from the archives of the Pathological anatomy of the
IRE.
The prospective study foresees the collection of biological samples by the centers
involved in the study and the freezing of all the samples at the IRE Biological Bank.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients with histologically proven primary invasive breast cancer >1.5cm in size,
with molecular assessed stage IIA to IIIB defined as TNBC, and who will undergo
neoadjuvant chemotherapy and subsequent surgery (and/or have undergone -
retrospective part).
- informed consent (prospective part)
Exclusion Criteria:
- pregnancy, metastatic breast cancer, previous chemotherapy, hormone therapy,
radiation therapy, previous other cancers or contralateral breast cancer
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Policlinico Umberto I
Address:
City:
Roma
Zip:
00161
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Paolo Marchetti
Facility:
Name:
"Regina Elena" National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Start date:
December 14, 2021
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05807516
