Autotaxin: a Potential Biomarker for Breast Cancer.

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Biological: measurement of serum autotaxin serum level

• Registration Number: NCT05680311
• Lead Sponsor: Ankara Etlik City Hospital

Brief Summary

The goal of this clinical trial is to test the efficiency of Autotaxin (ATX) as a biomarker for breast cancer patients.

The main questions it aims to answer are;

* is ATX a reliable tumor marker for breast cancer patients in diagnosis

* can ATX differentiate cancer patients from non-cancer ones

Detailed Description

80 breast cancer patients and 30 normal patients with no known cancer history were enrolled in this study. All patients were female. The mean ages of cancer patients were 58.2 and 52.7 consecutively for cancer and non-cancer patients. The mean serum ATX levels of cancer and non-cancer patients were 1570.72 and 121.86 ng/mL consecutively (p=0.001). The cut-off value of ATX serum level was 178.49ng/mL according to the ROC analysis. The area under the ROC curve was 0.901showing that ATX is very efficient in distinguishing between two diagnostic groups (diseased/normal). ATX also showed good correlations with known tumor markers (CEA, CA15-3, CA125 levels). ATX levels were still higher than the cut-off value even in cancer patients with normal or low classical tumor marker levels.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-15
• Study First Submitted: 2022-12-26
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-11
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Preoperatively diagnosed breast cancer patients with no synchronous cancer and without known hepatic or other inflammatory disorders.

Exclusion Criteria

• Patients with benign breast diseases and no known cancer history.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Cancer patients	measurement of serum autotaxin serum level	Group of healthy patients with no verified any type of cancer.
Breast Cancer Patients	measurement of serum autotaxin serum level	Group of patients with verified breast cancer diagnosis

Primary Outcome Measures

Name	Time	Method
Autotaxin as a tumor marker	preoperative period	Diagnostic value of Autotaxin in breast cancer

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Turkey