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Trial Title:
Serum Retinoic Acid Induced Protein 14 (RAI14) and Metastasis Associated Cancer Colon -1 (MACC-1) in Breast Cancer
NCT ID:
NCT06097546
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
laboratory test (RAI14 and MACC-1 )
Description:
Measurement of serum RAI14 and serum MACC-1 levels by immunochemical assays
Arm group label:
Benign lesions
Arm group label:
Breast cancer patients
Arm group label:
Control
Summary:
1. Measurement of serum levels of Retinoic acid induced 14 (RAI14) and Metastasis
associated cancer colon -1 (MACC-1) as biomarkers for diagnosis of breast cancer.
2. Study their relationship to disease stages and clinicopathological features of BC.
3. Compare the diagnostic performance of serum RAI14 and serum MACC-1 with serum
Carcinoembryonic antigen (CEA) and Cancer antigen 15-3 (CA15-3) for diagnosis of BC.
Detailed description:
Breast cancer (BC) is one of the most prevalent Neoplasms and the second leading reason
of death from cancer in women. Every year approximately 2.3 million new cases of BC are
diagnosed worldwide. Due to the high impact of this type of cancer, the early detection,
early diagnosis and effective treatment, will improve the diagnosis of patients and lower
the associated mortality rates. Carcinoembryonic antigen (CEA) and Cancer antigen 15-3
(CA15-3) are the most commonly used serum markers in the diagnosis and follow up of BC,
However their clinical applications still remain controversial.
Retinoic acid induced protein 14 (RAI14) is an actin-binding protein which participates
in physiological processes such as the regulation of cell polarity and transport of
spermatozoa. Recent studies showed that RAI14 is overexpressed in several malignant
tumors with a significant role in the development of tumors . The serum RAI14 is a
reliable novel marker in the early diagnosis and chemotherapy monitoring of
triple-negative BC.
Metastasis-associated colon cancer-1 (MACC-1) is a newly identified tumor marker, first
identified in colon cancer tissue as a prognostic indicator and inducer of metastasis .It
is located on human chromosome 7 (7p21.1) and shown to be a key regulator of the
hepatocyte growth factor-mesenchymal epithelial transition factor( HGF-MET) pathway in
colon cancer. It is shown that serum MACC-1 can be a potential biomarker for diagnosis
and progression in patients with BC. There was a strong correlation between MACC-1
expression and the clinical and the primary tumor, regional nodes, metastasis (TNM)
stages of BC.
Criteria for eligibility:
Study pop:
The study will be carried out on 3 groups
- Group (1)(patient group):
30 newly diagnosed patients with breast cancer, who will be admitted Clinical
Pathology Department, Assiut University Hospitals, Assiut University Patients group
will be furtherly subclassified according to the TNM staging classification .
- Group (2) (benign lesions) 30 diagnosed patients with benign breast lesions.
- Group (3) (control group):
30 apparently healthy individuals with matched age and sex are included in this
study as a control group for comparison.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Patients with benign breast lesions.
2. Patients with breast cancer who were confirmed by histopathological studies and did
not receive any treatment.
Exclusion Criteria: 1- Patients who received chemotherapy or radiotherapy. 2- Patients
with known other organ malignancy.
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Start date:
November 1, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06097546
