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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06097546
Collaborator
(none)
90
25

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: laboratory test (RAI14 and MACC-1 )

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Evaluation of Serum Retinoic Acid Induced Protein 14 (RAI14) and Metastasis Associated Cancer Colon -1 (MACC-1) as Biomarkers for Breast Cancer
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Breast cancer patients

Newly diagnosed patients with breast cancer

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

Benign lesions

Diagnosed patients with benign breast lesions

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

Control

apparently healthy individuals with matched age and sex

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

Outcome Measures

Primary Outcome Measures

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

    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

Secondary Outcome Measures

  1. 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. [Baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alaa Atef Mohamed Elbadry, Prinicipal investigator (doctor), Assiut University
ClinicalTrials.gov Identifier:
NCT06097546
Other Study ID Numbers:
  • Markers in Breast Cancer
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2023