Clinical trial NCT05680311: Autotaxin: a Potential Biomarker for Breast Cancer.
Official title: Is Autotaxin a Promising Biomarker for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
autotaxin
tumor marker
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Diskapi Yildirim Beyazit Education and Research Hospital
First posted: 2023-01-11
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Autotaxin as a tumor marker
timeFrame: preoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: Ankara Etlik City Hospital
name: Duray Seker, Professor
role: STUDY_CHAIR
References:
citation: Lukasiewicz S, Czeczelewski M, Forma A, Baj J, Sitarz R, Stanislawek A. Breast Cancer-Epidemiology, Risk Factors, Classification, Prognostic Markers, and Current Treatment Strategies-An Updated Review. Cancers (Basel). 2021 Aug 25;13(17):4287. doi: 10.3390/cancers13174287.
citation: Gaetano CG, Samadi N, Tomsig JL, Macdonald TL, Lynch KR, Brindley DN. Inhibition of autotaxin production or activity blocks lysophosphatidylcholine-induced migration of human breast cancer and melanoma cells. Mol Carcinog. 2009 Sep;48(9):801-9. doi: 10.1002/mc.20524.
citation: Brindley DN, Tang X, Meng G, Benesch MGK. Role of Adipose Tissue-Derived Autotaxin, Lysophosphatidate Signaling, and Inflammation in the Progression and Treatment of Breast Cancer. Int J Mol Sci. 2020 Aug 18;21(16):5938. doi: 10.3390/ijms21165938.