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

NCT ID: NCT06097546

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Breast cancer patients

Newly diagnosed patients with breast cancer

laboratory test (RAI14 and MACC-1 )

Intervention Type DIAGNOSTIC_TEST

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

Benign lesions

Diagnosed patients with benign breast lesions

laboratory test (RAI14 and MACC-1 )

Intervention Type DIAGNOSTIC_TEST

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

Control

apparently healthy individuals with matched age and sex

laboratory test (RAI14 and MACC-1 )

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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laboratory test (RAI14 and MACC-1 )

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Atef Mohamed Elbadry

Prinicipal investigator (doctor)

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Alaa Atef, MD

Role: CONTACT

01114341538

Mohamed Samir, professor

Role: CONTACT

01015484723

References

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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.

Reference Type BACKGROUND
PMID: 36880986 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36979146 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33400729 (View on PubMed)

Other Identifiers

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Markers in Breast Cancer

Identifier Type: -

Identifier Source: org_study_id

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