NCT05680311

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

December 26, 2022

Last Update Submit

January 25, 2023

Conditions

Breast Cancer

Keywords

breast cancerautotaxintumor marker

Outcome Measures

Primary Outcomes (1)

  • Autotaxin as a tumor marker

    Diagnostic value of Autotaxin in breast cancer

    preoperative period

Study Arms (2)

Breast Cancer Patients

ACTIVE COMPARATOR

Group of patients with verified breast cancer diagnosis

Biological: measurement of serum autotaxin serum level

Non-Cancer patients

SHAM COMPARATOR

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

Biological: measurement of serum autotaxin serum level

Interventions

measurement of serum autotaxin serum levelBIOLOGICAL

autotaxin expression

Breast Cancer PatientsNon-Cancer patients

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Preoperatively diagnosed breast cancer patients with no synchronous cancer and without known hepatic or other inflammatory disorders.

You may not qualify if:

  • Patients with benign breast diseases and no known cancer history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 34503097RESULT

  • 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.

    PMID: 19204929RESULT

  • 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.

    PMID: 32824846RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Duray Seker, Professor

    Ankara Etlik City Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

December 26, 2022

First Posted

January 11, 2023

Study Start

January 1, 2019

Primary Completion

December 31, 2020

Study Completion

March 15, 2021

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

all collected IPD

Shared Documents
STUDY PROTOCOL
Time Frame
from the onset of publication
Access Criteria
Only access criteria is citing the article

Locations

TU(1)