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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05680311
Other study ID # autotaxin1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date March 15, 2021

Study information

Verified date January 2023
Source Ankara Etlik City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date March 15, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
measurement of serum autotaxin serum level
autotaxin expression

Locations

Country Name City State
Turkey Ankara Etlik City Hospital Ankara

Sponsors (2)

Lead Sponsor Collaborator
Ankara Etlik City Hospital Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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: 10.10 — View 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: 10.339 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Autotaxin as a tumor marker Diagnostic value of Autotaxin in breast cancer preoperative period
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