Breast CancerNCT04328194
Autotaxin (ATX) as a Marker for Breast Cancer
A study testing Serum Autotaxin, chest x-ray and Breast ultrasound or mammography in people with Breast Cancer, run by Assiut University.
Trial summary
Breast cancer is the leading cause of cancer death in women worldwide. According to the GLOBOCAN 2018 worldwide estimates of cancer incidence and mortality, in 2018, about 2,088,849 new cases were diagnosed and approximately 626,679 women were predicted to die from the disease . Read more about this study
- Who is it for?
- Ages 19 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Serum Autotaxin, chest x-ray and Breast ultrasound or mammography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Nov 2022
- 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 19 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study will be conducted on one hundred female individuals; 80 newly diagnosed breast cancer patients before any treatment or surgical intervention and 20 apparently normal female individuals.
Who cannot join
- Patients with any other type of malignant or benign tumors, renal failure, cardiovascular diseases and liver cirrhosis were excluded from our study.
- Past history of chemotherapy or surgical treatment of any malignancy.
- Inflammatory diseases (e.g.bronchitis) or autoimmune diseases (e.g.rheumatoid arthritis).
Trial locations and contacts
No sites are listed yet.
About this study
Breast cancer is the leading cause of cancer death in women worldwide. According to the GLOBOCAN 2018 worldwide estimates of cancer incidence and mortality, in 2018, about 2,088,849 new cases were diagnosed and approximately 626,679 women were predicted to die from the disease . It is the leading cause of cancer related mortality, representing15% of deaths per year worldwide .
Read the detailed description
Breast cancer is the most common malignancy in females in Egypt. It accounts for 32 % of cancer in women . Breast cancer in Egypt carries an unfavorable prognosis with 29% mortality and 3.7:1 incidence to mortality ratio .
Despite the rising incidence of breast cancer, the survival rates have improved in recent years due to the deep research in biological behavior of breast cancer . Although the current 5-year survival for primary breast cancer is relatively high (ranging from 80% to 92% in different populations) survival rates decrease to less than 25% when the disease becomes metastatic .These data support the need to develop more efficient strategies for preventive, intervention, evaluation of therapy, and prediction of prognosis .
Autotaxin (ATX) is a glycoprotein encoded by the ENPP2 (Ectonucleotide Pyrophosphatase/Phosphodiesterase 2) gene located on chromosome 8. Identical to lysophospholipase D, ATX plays a role in the synthesis of the bioactive lipid mediator lysophosphatidate (LPA) from lysophosphatidylcholine (LPC) .
LPA acts through specific G protein-coupled receptors (GPCRs) to promote cellular proliferation, migration, and survival . ATX expression was also reported higher in poorly differentiated tumors and, in independent studies, is correlated with invasiveness of cancer cells suggesting a higher metastatic potential of ATX-expressing tumors . ATX is generated from platelets, endothelial cells, fibroblasts, and adipocytes and specifically, ATX from adipocytes has an impact on plasma LPA level . Thus, adipocytes could be an important origin of ATX in tumors. Breast cancer is a human cancer that has adipocyte-rich stroma. Adipose tissue comprises 56% of non-lactating breast tissue, and 35% of lactating breast tissue . ATX-LPA signaling has been reported to be involved in angiogenesis, tumor cell invasion, and migration in breast cancer .
Increased ATX expression has also been reported in various forms of cancer, such as glioblastoma, hepatocellular and thyroid carcinomas, pancreatic and hematological cancers. A large number of evidence indicate that ATX-LPA is associated with chemotherapy resistance of cancer, and in breast cancer, ATX can reverse cell apoptosis.
In a mouse model, α-bromomethylene phosphonate LPA (BrP-LPA), a dual ATX and pan-LPAR( Lysophosphatidic acid receptor ) inhibitor, inhibited migration and invasion of breast cancer cell lines and suppressed primary tumor and angiogenesis in a mouse xenograft study . Since tumor and stromal cells in breast cancer express ATX-LPA signaling-related proteins, inhibition of the ATX-LPA axis could be of therapeutic importance .Therefore, further study ATX as a tumor marker in breast cancer is required.
- Conditions
- Breast Cancer
- Being tested
- Serum Autotaxin, chest x-ray, Breast ultrasound or mammography, Histopathological examination of breast mass specimens, Magnetic Resonance Imaging ( MRI) and Bone scan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum AutotaxinDiagnostic test
Marker
chest x-rayRadiation
chest x- ray will be done for the study group
Breast ultrasound or mammographyDiagnostic test
Breast ultrasound or mammography will be done for the study group to diagnosis of breast cancer
Histopathological examination of breast mass specimensDiagnostic test
by True cut or fine needle aspiration cytology
Magnetic Resonance Imaging ( MRI) and Bone scanRadiation
will be done for the study group
Peripheral haemogramDiagnostic test
blood sample will be taken from the patients
Renal and liver functionsDiagnostic test
to exclude any other morbidity
Prothrombin time and concentrationDiagnostic test
blood sample will be taken from the patients
Cancer Antigen 15-3 (CA15-3).Diagnostic test
will be done for the 2 groups
Full medical historyOther
full medical history will be taken from all patients
Full clinical examinationOther
full clinical examination will be done for the patients
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | 80 patients with breast cancer Receives: Diagnostic Test: Serum Autotaxin; Radiation: chest x-ray; Diagnostic Test: Breast ultrasound or mammography; Diagnostic Test: Histopathological examination of breast mass specimens; Radiation: Magnetic Resonance Imaging ( MRI) and Bone scan; Diagnostic Test: Peripheral haemogram; Diagnostic Test: Renal and liver functions; Diagnostic Test: Prothrombin time and concentration; Diagnostic Test: Cancer Antigen 15-3 (CA15-3).; Other: Full medical history; Other: Full clinical examination |
| Control Group | Placebo comparator | 20 healthy controls aged ( 19 to 69 years ) from healthy volunteers after informed consent. Receives: Diagnostic Test: Serum Autotaxin; Diagnostic Test: Cancer Antigen 15-3 (CA15-3).; Other: Full medical history; Other: Full clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the level of serum ATX as a diagnostic marker for breast cancer.
blood sample will be taken from the patients for measure of serum ATX
Measured: Baseline (before any treatment)
Secondary outcomes (1)
To establish a cut off for serum ATX as a marker for breast cancer
blood sample will be taken from the patients for measure of serum ATX
Measured: Baseline (before any treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 May 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)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 Assiut UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Gamal Sudky, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328194
- Sponsor's protocol ID
- medicin
- Status last verified
- Mar 2020
- First submitted
- 28 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boucharaba A, Serre CM, Gres S, Saulnier-Blache JS, Bordet JC, Guglielmi J, Clezardin P, Peyruchaud O. Platelet-derived lysophosphatidic acid supports the progression of osteolytic bone metastases in breast cancer. J Clin Invest. 2004 Dec;114(12):1714-25. doi: 10.1172/JCI22123.
PubMed 15599396Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Choi JW, Herr DR, Noguchi K, Yung YC, Lee CW, Mutoh T, Lin ME, Teo ST, Park KE, Mosley AN, Chun J. LPA receptors: subtypes and biological actions. Annu Rev Pharmacol Toxicol. 2010;50:157-86. doi: 10.1146/annurev.pharmtox.010909.105753.
PubMed 20055701Dusaulcy R, Rancoule C, Gres S, Wanecq E, Colom A, Guigne C, van Meeteren LA, Moolenaar WH, Valet P, Saulnier-Blache JS. Adipose-specific disruption of autotaxin enhances nutritional fattening and reduces plasma lysophosphatidic acid. J Lipid Res. 2011 Jun;52(6):1247-1255. doi: 10.1194/jlr.M014985. Epub 2011 Mar 18.
PubMed 21421848Ferry G, Tellier E, Try A, Gres S, Naime I, Simon MF, Rodriguez M, Boucher J, Tack I, Gesta S, Chomarat P, Dieu M, Raes M, Galizzi JP, Valet P, Boutin JA, Saulnier-Blache JS. Autotaxin is released from adipocytes, catalyzes lysophosphatidic acid synthesis, and activates preadipocyte proliferation. Up-regulated expression with adipocyte differentiation and obesity. J Biol Chem. 2003 May 16;278(20):18162-9. doi: 10.1074/jbc.M301158200. Epub 2003 Mar 17.
PubMed 12642576Hinestrosa MC, Dickersin K, Klein P, Mayer M, Noss K, Slamon D, Sledge G, Visco FM. Shaping the future of biomarker research in breast cancer to ensure clinical relevance. Nat Rev Cancer. 2007 Apr;7(4):309-15. doi: 10.1038/nrc2113.
PubMed 17384585Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
PubMed 25328522Jansen S, Stefan C, Creemers JW, Waelkens E, Van Eynde A, Stalmans W, Bollen M. Proteolytic maturation and activation of autotaxin (NPP2), a secreted metastasis-enhancing lysophospholipase D. J Cell Sci. 2005 Jul 15;118(Pt 14):3081-9. doi: 10.1242/jcs.02438. Epub 2005 Jun 28.
PubMed 15985467Kazama S, Kitayama J, Aoki J, Mori K, Nagawa H. Immunohistochemical detection of autotaxin (ATX)/lysophospholipase D (lysoPLD) in submucosal invasive colorectal cancer. J Gastrointest Cancer. 2011 Dec;42(4):204-11. doi: 10.1007/s12029-010-9186-4.
PubMed 20623382Leblanc R, Peyruchaud O. New insights into the autotaxin/LPA axis in cancer development and metastasis. Exp Cell Res. 2015 May 1;333(2):183-189. doi: 10.1016/j.yexcr.2014.11.010. Epub 2014 Nov 25.
PubMed 25460336Lonning PE. Breast cancer prognostication and prediction: are we making progress? Ann Oncol. 2007 Sep;18 Suppl 8:viii3-7. doi: 10.1093/annonc/mdm260.
PubMed 17890212Mao Y, Keller ET, Garfield DH, Shen K, Wang J. Stromal cells in tumor microenvironment and breast cancer. Cancer Metastasis Rev. 2013 Jun;32(1-2):303-15. doi: 10.1007/s10555-012-9415-3.
PubMed 23114846Nikitopoulou I, Oikonomou N, Karouzakis E, Sevastou I, Nikolaidou-Katsaridou N, Zhao Z, Mersinias V, Armaka M, Xu Y, Masu M, Mills GB, Gay S, Kollias G, Aidinis V. Autotaxin expression from synovial fibroblasts is essential for the pathogenesis of modeled arthritis. J Exp Med. 2012 May 7;209(5):925-33. doi: 10.1084/jem.20112012. Epub 2012 Apr 9.
PubMed 22493518Ramsay DT, Kent JC, Hartmann RA, Hartmann PE. Anatomy of the lactating human breast redefined with ultrasound imaging. J Anat. 2005 Jun;206(6):525-34. doi: 10.1111/j.1469-7580.2005.00417.x.
PubMed 15960763Reis-Filho JS, Pusztai L. Gene expression profiling in breast cancer: classification, prognostication, and prediction. Lancet. 2011 Nov 19;378(9805):1812-23. doi: 10.1016/S0140-6736(11)61539-0.
PubMed 22098854
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autotaxin (ATX) as a Marker for Breast Cancer
- ClinicalTrials.gov ID
- NCT04328194
- Acronym / sponsor ID
- medicin
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 31 Mar 2020 (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.
Breast cancer is the leading cause of cancer death in women worldwide. According to the GLOBOCAN 2018 worldwide estimates of cancer incidence and mortality, in 2018, about 2,088,849 new cases were diagnosed and approximately 626,679 women were predicted to die from the disease . It is the leading cause of cancer related mortality, representing15% of deaths per year worldwide .
Detailed description
Breast cancer is the most common malignancy in females in Egypt. It accounts for 32 % of cancer in women . Breast cancer in Egypt carries an unfavorable prognosis with 29% mortality and 3.7:1 incidence to mortality ratio .
Despite the rising incidence of breast cancer, the survival rates have improved in recent years due to the deep research in biological behavior of breast cancer . Although the current 5-year survival for primary breast cancer is relatively high (ranging from 80% to 92% in different populations) survival rates decrease to less than 25% when the disease becomes metastatic .These data support the need to develop more efficient strategies for preventive, intervention, evaluation of therapy, and prediction of prognosis .
Autotaxin (ATX) is a glycoprotein encoded by the ENPP2 (Ectonucleotide Pyrophosphatase/Phosphodiesterase 2) gene located on chromosome 8. Identical to lysophospholipase D, ATX plays a role in the synthesis of the bioactive lipid mediator lysophosphatidate (LPA) from lysophosphatidylcholine (LPC) .
LPA acts through specific G protein-coupled receptors (GPCRs) to promote cellular proliferation, migration, and survival . ATX expression was also reported higher in poorly differentiated tumors and, in independent studies, is correlated with invasiveness of cancer cells suggesting a higher metastatic potential of ATX-expressing tumors . ATX is generated from platelets, endothelial cells, fibroblasts, and adipocytes and specifically, ATX from adipocytes has an impact on plasma LPA level . Thus, adipocytes could be an important origin of ATX in tumors. Breast cancer is a human cancer that has adipocyte-rich stroma. Adipose tissue comprises 56% of non-lactating breast tissue, and 35% of lactating breast tissue . ATX-LPA signaling has been reported to be involved in angiogenesis, tumor cell invasion, and migration in breast cancer .
Increased ATX expression has also been reported in various forms of cancer, such as glioblastoma, hepatocellular and thyroid carcinomas, pancreatic and hematological cancers. A large number of evidence indicate that ATX-LPA is associated with chemotherapy resistance of cancer, and in breast cancer, ATX can reverse cell apoptosis.
In a mouse model, α-bromomethylene phosphonate LPA (BrP-LPA), a dual ATX and pan-LPAR( Lysophosphatidic acid receptor ) inhibitor, inhibited migration and invasion of breast cancer cell lines and suppressed primary tumor and angiogenesis in a mouse xenograft study . Since tumor and stromal cells in breast cancer express ATX-LPA signaling-related proteins, inhibition of the ATX-LPA axis could be of therapeutic importance .Therefore, further study ATX as a tumor marker in breast cancer is required.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Diagnostic Test: Serum Autotaxin, Radiation: chest x-ray, Diagnostic Test: Breast ultrasound or mammography, Diagnostic Test: Histopathological examination of breast mass specimens, Radiation: Magnetic Resonance Imaging ( MRI) and Bone scan, Diagnostic Test: Peripheral haemogram, Diagnostic Test: Renal and liver functions, Diagnostic Test: Prothrombin time and concentration, Diagnostic Test: Cancer Antigen 15-3 (CA15-3)., Other: Full medical history, Other: Full clinical examination80 patients with breast cancer |
| Control Group | Placebo comparator | Diagnostic Test: Serum Autotaxin, Diagnostic Test: Cancer Antigen 15-3 (CA15-3)., Other: Full medical history, Other: Full clinical examination20 healthy controls aged ( 19 to 69 years ) from healthy volunteers after informed consent. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study will be conducted on one hundred female individuals; 80 newly diagnosed breast cancer patients before any treatment or surgical intervention and 20 apparently normal female individuals.
Key exclusion criteria (3 listed)
- Patients with any other type of malignant or benign tumors, renal failure, cardiovascular diseases and liver cirrhosis were excluded from our study.
- Past history of chemotherapy or surgical treatment of any malignancy.
- Inflammatory diseases (e.g.bronchitis) or autoimmune diseases (e.g.rheumatoid arthritis).
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 |
|---|---|---|
| Serum AutotaxinMarker | Diagnostic test | Control Group, Study Group |
| chest x-raychest x- ray will be done for the study group | Radiation | Study Group |
| Breast ultrasound or mammographyBreast ultrasound or mammography will be done for the study group to diagnosis of breast cancer | Diagnostic test | Study Group |
| Histopathological examination of breast mass specimensby True cut or fine needle aspiration cytology | Diagnostic test | Study Group |
| Magnetic Resonance Imaging ( MRI) and Bone scanwill be done for the study group | Radiation | Study Group |
| Peripheral haemogramblood sample will be taken from the patients | Diagnostic test | Study Group |
| Renal and liver functionsto exclude any other morbidity | Diagnostic test | Study Group |
| Prothrombin time and concentrationblood sample will be taken from the patients | Diagnostic test | Study Group |
| Cancer Antigen 15-3 (CA15-3).will be done for the 2 groups | Diagnostic test | Control Group, Study Group |
| Full medical historyfull medical history will be taken from all patients | Other | Control Group, Study Group |
| Full clinical examinationfull clinical examination will be done for the patients | Other | Control Group, Study Group |
Primary outcome
To estimate the level of serum ATX as a diagnostic marker for breast cancer.
Time frame: Baseline (before any treatment)
blood sample will be taken from the patients for measure of serum ATX
1 secondary outcome
To establish a cut off for serum ATX as a marker for breast cancer
Time frame: Baseline (before any treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Results publication: PubMed 15599396Boucharaba A, Serre CM, Gres S, Saulnier-Blache JS, Bordet JC, Guglielmi J, Clezardin P, Peyruchaud O. Platelet-derived lysophosphatidic acid supports the progression of osteolytic bone metastases in breast cancer. J Clin Invest. 2004 Dec;114(12):1714-25. doi: 10.1172/JCI22123.
- Results publication: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Results publication: PubMed 20055701Choi JW, Herr DR, Noguchi K, Yung YC, Lee CW, Mutoh T, Lin ME, Teo ST, Park KE, Mosley AN, Chun J. LPA receptors: subtypes and biological actions. Annu Rev Pharmacol Toxicol. 2010;50:157-86. doi: 10.1146/annurev.pharmtox.010909.105753.
- Results publication: PubMed 21421848Dusaulcy R, Rancoule C, Gres S, Wanecq E, Colom A, Guigne C, van Meeteren LA, Moolenaar WH, Valet P, Saulnier-Blache JS. Adipose-specific disruption of autotaxin enhances nutritional fattening and reduces plasma lysophosphatidic acid. J Lipid Res. 2011 Jun;52(6):1247-1255. doi: 10.1194/jlr.M014985. Epub 2011 Mar 18.
- Results publication: PubMed 12642576Ferry G, Tellier E, Try A, Gres S, Naime I, Simon MF, Rodriguez M, Boucher J, Tack I, Gesta S, Chomarat P, Dieu M, Raes M, Galizzi JP, Valet P, Boutin JA, Saulnier-Blache JS. Autotaxin is released from adipocytes, catalyzes lysophosphatidic acid synthesis, and activates preadipocyte proliferation. Up-regulated expression with adipocyte differentiation and obesity. J Biol Chem. 2003 May 16;278(20):18162-9. doi: 10.1074/jbc.M301158200. Epub 2003 Mar 17.
- Results publication: PubMed 17384585Hinestrosa MC, Dickersin K, Klein P, Mayer M, Noss K, Slamon D, Sledge G, Visco FM. Shaping the future of biomarker research in breast cancer to ensure clinical relevance. Nat Rev Cancer. 2007 Apr;7(4):309-15. doi: 10.1038/nrc2113.
- Results publication: PubMed 25328522Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
- Results publication: PubMed 15985467Jansen S, Stefan C, Creemers JW, Waelkens E, Van Eynde A, Stalmans W, Bollen M. Proteolytic maturation and activation of autotaxin (NPP2), a secreted metastasis-enhancing lysophospholipase D. J Cell Sci. 2005 Jul 15;118(Pt 14):3081-9. doi: 10.1242/jcs.02438. Epub 2005 Jun 28.
- Results publication: PubMed 20623382Kazama S, Kitayama J, Aoki J, Mori K, Nagawa H. Immunohistochemical detection of autotaxin (ATX)/lysophospholipase D (lysoPLD) in submucosal invasive colorectal cancer. J Gastrointest Cancer. 2011 Dec;42(4):204-11. doi: 10.1007/s12029-010-9186-4.
- Results publication: PubMed 25460336Leblanc R, Peyruchaud O. New insights into the autotaxin/LPA axis in cancer development and metastasis. Exp Cell Res. 2015 May 1;333(2):183-189. doi: 10.1016/j.yexcr.2014.11.010. Epub 2014 Nov 25.
- Results publication: PubMed 17890212Lonning PE. Breast cancer prognostication and prediction: are we making progress? Ann Oncol. 2007 Sep;18 Suppl 8:viii3-7. doi: 10.1093/annonc/mdm260.
- Results publication: PubMed 23114846Mao Y, Keller ET, Garfield DH, Shen K, Wang J. Stromal cells in tumor microenvironment and breast cancer. Cancer Metastasis Rev. 2013 Jun;32(1-2):303-15. doi: 10.1007/s10555-012-9415-3.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Serum Autotaxin, chest x-ray and Breast ultrasound or mammography in people with Breast Cancer, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanan Hareth, MD (01002954322, abdlatif@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the level of serum ATX as a diagnostic marker for breast cancer. (time frame: Baseline (before any treatment)). 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 NCT04328194, which also lists 24 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 31 Mar 2020.