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Trial Title:
Association of Cancer-Associated Fibroblast Density in the Peritumoral Stroma with Clinicopathological Data in Breast Cancer
NCT ID:
NCT06666517
Condition:
Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
cancer associated fibroblast
breast cancer
tumor microenvironment
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Basic Science
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
Description:
Routine surgery after neoadjuvant chemotherapy for breast cancer according to current
guidelines.
Arm group label:
5- Surgery Phase
Intervention type:
Other
Intervention name:
Immunohistochemistry Analysis
Description:
Determination of breast cancer subtypes through immunohistochemical analysis, and
selection of Luminal B, HER2-positive, and triple-negative groups.
Arm group label:
1- Subtyping of Breast Cancer Patients.
Intervention type:
Procedure
Intervention name:
Second Biopsy
Description:
Taking biopsies from the center of the tumor and the peritumoral stroma of the same mass
during marking of the mass before neoadjuvant chemotherapy
Arm group label:
3- Second Biopsy
Summary:
Research Question:
Is there a relationship between the clinical prognosis and pathological data of breast
cancer patients and the density of cancer-associated fibroblasts in the peritumoral
stroma?
Objectives of the Study:
1. Detection of cancer-associated fibroblasts in the tumor microenvironment across
different breast cancer subtypes.
2. Examination of the correlation between the clinical prognosis and pathological data
of patients with different breast cancer subtypes and cancer-associated fibroblast
subtypes.
The goal of this study based on the correlation obtained, the aim is to propose
cancer-associated fibroblasts as a more effective marker for breast cancer classification
and prognosis.
Detailed description:
During the routine marking before neoadjuvant chemotherapy of breast cancer patients with
triple-negative, HER2-positive, or Luminal B molecular subtypes, the correlation between
the density of cancer-associated fibroblasts in the samples taken from the center of the
tumor and the peritumoral stroma of the same mass with the patient's clinical prognosis
and pathological data will be examined.
Approach and Methods:
Collection of Tissue Samples via Core Needle Biopsy from Breast Cancer Patients (Luminal
B, HER2 Group, and Triple-Negative Group):
Breast masses will be examined supine using an ultrasound machine with a 14 MHz linear
transducer. The tumor and peritumoral parenchyma will be evaluated using a 1.5 T MRI
machine with a 16-channel breast coil, in the prone position, under dynamic
contrast-enhanced and diffusion-weighted imaging guidance. Under sonographic guidance and
local anesthesia, one tissue sample will be taken from the center of the mass using a
14G/10 cm core needle immediately before marking for neoadjuvant chemotherapy. One tissue
sample will be taken from the peritumoral stroma where diffusion restriction is shown in
diffusion-weighted MRI from patients diagnosed with Luminal B, HER2, or triple-negative
malignancy.
Identification of Cancer-Associated Fibroblasts via Immunohistochemical Analysis:
For immunohistochemical analysis, 3 µm thick sections will be taken from paraffin blocks
prepared from the core needle biopsy tissues from the periphery of the tumor, and the
blocks will be deparaffinized in an incubator at 60 °C. The prepared slides will be
stained using the LEICA Bond III fully automated IHC system, with the FAPα antibody, SMA
antibody, and PDGFR-β antibody. Diaminobenzidine (DAB) will be used as the chromogen.
Positive control tissues will include Fibroblast Activation Protein, alpha [SP325] Conc.
0.1mL (1:100) colon adenocarcinoma, Actin Smooth Muscle [1A4] Conc. 0.1mL (1:100-500)
appendix, and PDGFR-B [D-6] C.Liq.1ml (1:50-500) kidney.
The immunohistochemical analysis of the patient under clinical follow-up will be compared
with the type of surgery performed, the pathological data, and the clinical prognosis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients diagnosed with histopathologically confirmed Luminal B, HER2-positive, or
triple-negative breast cancer subtypes.
- Patients who have not previously received any neoadjuvant chemoradiotherapy.
- Patients over 18 years of age.
- Adequate cellularity in biopsies obtained via core needle biopsy.
Exclusion Criteria:
- Patients diagnosed with histopathologically confirmed Luminal A breast cancer
subtype.
- Patients who have previously received any neoadjuvant chemoradiotherapy.
- Patients under 18 years of age.
- Inadequate cellularity in biopsies obtained via core needle biopsy.
Gender:
Female
Gender based:
Yes
Gender description:
This study aims to detect cancer-associated fibroblasts in female breast cancer. Male
breast cancer has a different mechanism from female breast cancer.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Haydarpasa Numune Training and Research Hospital
Address:
City:
Istanbul
Zip:
34668
Country:
Turkey
Start date:
April 1, 2021
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Haydarpasa Numune Training and Research Hospital
Agency class:
Other
Source:
Haydarpasa Numune Training and Research Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06666517
