Autotaxin: a Potential Biomarker for Breast Cancer.

January 25, 2023 updated by: Gaye Seker, Ankara Etlik City Hospital

Is Autotaxin a Promising Biomarker for Breast Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06170
        • Ankara Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Breast Cancer Patients
Group of patients with verified breast cancer diagnosis
Biological: measurement of serum autotaxin serum level
autotaxin expression
Sham Comparator: Non-Cancer patients
Group of healthy patients with no verified any type of cancer.
Biological: measurement of serum autotaxin serum level
autotaxin expression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autotaxin as a tumor marker
Time Frame: preoperative period
Diagnostic value of Autotaxin in breast cancer
preoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Collaborators

Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

  • Study Chair: Duray Seker, Professor, Ankara Etlik City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

December 26, 2022

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 11, 2023

Study Record Updates

Last Update Posted (Actual)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • autotaxin1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all collected IPD

IPD Sharing Time Frame

from the onset of publication

IPD Sharing Access Criteria

Only access criteria is citing the article

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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