Serum Retinoic Acid Induced Protein 14 (RAI14) and Metastasis Associated Cancer Colon -1 (MACC-1) in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Evaluation of Serum Retinoic Acid Induced Protein 14 (RAI14) and Metastasis Associated Cancer Colon -1 (MACC-1) as Biomarkers for Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06097546
• Other study ID #: Markers in Breast Cancer
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Alaa Atef, MD
• Phone: 01114341538
• Email: alaa.atef_2012[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2025
• Est. primary completion date: November 1, 2025
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• laboratory test (RAI14 and MACC-1 )
Measurement of serum RAI14 and serum MACC-1 levels by immunochemical assays

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Ahmed M, Aslam M. Serum MACC-1: a new biomarker for breast cancer. Oncotarget. 2020 Dec 1;11(48):4521-4526. doi: 10.18632/oncotarget.27813. eCollection 2020 Dec 1. — View Citation

Cui R, Zou J, Zhao Y, Zhao T, Ren L, Li Y. The dual-crosslinked prospective values of RAI14 for the diagnosis and chemosurveillance in triple negative breast cancer. Ann Med. 2023 Dec;55(1):820-836. doi: 10.1080/07853890.2023.2177722. — View Citation

Lv M, Jiao Y, Yang B, Ye M, Di W, Su W, Zhong J. MACC1 as a Potential Target for the Treatment and Prevention of Breast Cancer. Biology (Basel). 2023 Mar 16;12(3):455. doi: 10.3390/biology12030455. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the diagnostic value of serum Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) for breast cancer patients.	Evaluation of the clinical utility of measurement of level of Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) in newly diagnosed breast cancer patients	Baseline
Secondary	Correlate the levels of serum Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) with the TNM staging in breast cancer patients.	Studying the correlation of levels of serum Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) with the TNM staging in breast cancer patient.	Baseline