Breast CancerNCT05680311
Autotaxin: a Potential Biomarker for Breast Cancer.
A study testing measurement of serum autotaxin serum level in people with Breast Cancer, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- measurement of serum autotaxin serum level
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Preoperatively diagnosed breast cancer patients with no synchronous cancer and without known hepatic or other inflammatory disorders.
Who cannot join
- Patients with benign breast diseases and no known cancer history.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- measurement of serum autotaxin serum level
- Keywords
- breast cancer, autotaxin, tumor marker
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of serum autotaxin serum levelBiological
autotaxin expression
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Patients | Active comparator | Group of patients with verified breast cancer diagnosis Receives: Biological: measurement of serum autotaxin serum level |
| Non-Cancer patients | Sham comparator | Group of healthy patients with no verified any type of cancer. Receives: Biological: measurement of serum autotaxin serum level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autotaxin as a tumor marker
Diagnostic value of Autotaxin in breast cancer
Measured: preoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Collaborators
- Diskapi Yildirim Beyazit Education and Research Hospital
- Responsible party
- Principal investigator, Gaye Seker, Ankara Etlik City Hospital
- Investigators
- Duray Seker, Professor, Study chair, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680311
- Sponsor's protocol ID
- autotaxin1
- Status last verified
- Jan 2023
- First submitted
- 26 Dec 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
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.
PubMed 34503097Gaetano 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.
PubMed 19204929Brindley 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.
PubMed 32824846
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Autotaxin a Promising Biomarker for Breast Cancer
- ClinicalTrials.gov ID
- NCT05680311
- Acronym / sponsor ID
- autotaxin1
- Conditions
- Breast Cancer
- Keywords
- breast cancer, autotaxin, tumor marker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Collaborators
- Diskapi Yildirim Beyazit Education and Research Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients | Active comparator | Biological: measurement of serum autotaxin serum levelGroup of patients with verified breast cancer diagnosis |
| Non-Cancer patients | Sham comparator | Biological: measurement of serum autotaxin serum levelGroup of healthy patients with no verified any type of cancer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Preoperatively diagnosed breast cancer patients with no synchronous cancer and without known hepatic or other inflammatory disorders.
Key exclusion criteria (1 listed)
- Patients with benign breast diseases and no known cancer history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of serum autotaxin serum levelautotaxin expression | Biological | Breast Cancer Patients, Non-Cancer patients |
Primary outcome
Autotaxin as a tumor marker
Time frame: preoperative period
Diagnostic value of Autotaxin in breast cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Results publication: PubMed 34503097Lukasiewicz 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.
- Results publication: PubMed 19204929Gaetano 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.
- Results publication: PubMed 32824846Brindley 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.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duray Seker, Professor study chair
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of serum autotaxin serum level in people with Breast Cancer, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autotaxin as a tumor marker (time frame: preoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05680311, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.