Autotaxin: a Potential Biomarker for Breast Cancer.

Ankara Etlik City Hospital

Status: Completed

Conditions: Breast Cancer

Treatments: Biological: measurement of serum autotaxin serum level

Study type: Interventional

Funder types: Other

Identifiers

NCT05680311

autotaxin1

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Breast Cancer Patients

Active Comparator group

Description:

Group of patients with verified breast cancer diagnosis

Treatment:

Biological: measurement of serum autotaxin serum level

Non-Cancer patients

Sham Comparator group

Description:

Group of healthy patients with no verified any type of cancer.

Treatment:

Biological: measurement of serum autotaxin serum level