NCT06097546

Brief Summary

  1. 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. 2.Study their relationship to disease stages and clinicopathological features of BC.
  3. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

October 7, 2023

Last Update Submit

October 18, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (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

Study Arms (3)

Breast cancer patients

Newly diagnosed patients with breast cancer

Diagnostic Test: laboratory test (RAI14 and MACC-1 )

Benign lesions

Diagnosed patients with benign breast lesions

Diagnostic Test: laboratory test (RAI14 and MACC-1 )

Control

apparently healthy individuals with matched age and sex

Diagnostic Test: laboratory test (RAI14 and MACC-1 )

Interventions

laboratory test (RAI14 and MACC-1 )DIAGNOSTIC_TEST

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

Benign lesionsBreast cancer patientsControl

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Patients with benign breast lesions.
  • Patients with breast cancer who were confirmed by histopathological studies and did not receive any treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 36880986BACKGROUND

  • 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.

    PMID: 36979146BACKGROUND

  • 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.

    PMID: 33400729BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Alaa Atef, MD

CONTACT

01114341538alaa.atef_2012@yahoo.com

Mohamed Samir, professor

CONTACT

01015484723msmkhalil@aun.adu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal investigator (doctor)

Study Record Dates

First Submitted

October 7, 2023

First Posted

October 24, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

October 24, 2023

Record last verified: 2023-10