Autotaxin: a Potential Biomarker for Breast Cancer.

NCT ID: NCT05680311

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-03-15

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Breast Cancer Patients

Group of patients with verified breast cancer diagnosis

Group Type ACTIVE_COMPARATOR

measurement of serum autotaxin serum level

Intervention Type BIOLOGICAL

autotaxin expression

Non-Cancer patients

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

Group Type SHAM_COMPARATOR

measurement of serum autotaxin serum level

Intervention Type BIOLOGICAL

autotaxin expression

Interventions

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measurement of serum autotaxin serum level

autotaxin expression

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gaye Seker

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duray Seker, Professor

Role: STUDY_CHAIR

Ankara Etlik City Hospital

Locations

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Ankara Etlik City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 34503097 (View on PubMed)

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.

Reference Type RESULT
PMID: 19204929 (View on PubMed)

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.

Reference Type RESULT
PMID: 32824846 (View on PubMed)

Other Identifiers

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autotaxin1

Identifier Type: -

Identifier Source: org_study_id

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