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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06097546
Enrollment
90
Registered
2023-10-24
Start date
2023-11-01
Completion date
2025-12-31
Last updated
2023-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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.

Interventions

DIAGNOSTIC_TESTlaboratory test (RAI14 and MACC-1 )

Measurement of serum RAI14 and serum MACC-1 levels by immunochemical assays

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the diagnostic value of serum Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) for breast cancer patients.BaselineEvaluation 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

Secondary

MeasureTime frameDescription
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.BaselineStudying 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.

Contacts

Primary ContactAlaa Atef, MD
alaa.atef_2012@yahoo.com01114341538
Backup ContactMohamed Samir, professor
msmkhalil@aun.adu.eg01015484723

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026