Breast CancerNCT03598660
Role of Sorcin and Annexin A3 in Breast Cancer Patients
An observational study of Breast Cancer, run by Assiut University.
Trial summary
Breast cancer (BC) is the most common female malignancy worldwide and the second leading cause of cancer death in women. One in eight women in the United States will develop the illness in their lifetimes. In Egypt, 37.7% of total cancer cases among women is breast cancer. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sorcin gene expression and Annexin A3 serum mesurement
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2019to 30 Sep 2019
- Phase
- Observational
- 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 20 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: breast cancer patients
Who may be able to join
- breast cancer patients before surgery who are admitted to the South Egypt Cancer Institute, Surgery Department, Assiut University
Who cannot join
- • Patients with malignancies elsewhere in the body.
- Patients with chronic cardiac diseases.
- Getting neoadjuvant chemotherapy.
- Renal disease.
- Neurodegenerative disease.
Trial locations and contacts
No sites are listed yet.
About this study
Breast cancer (BC) is the most common female malignancy worldwide and the second leading cause of cancer death in women. One in eight women in the United States will develop the illness in their lifetimes. In Egypt, 37.7% of total cancer cases among women is breast cancer. A locally advanced disease is very common and total mastectomy is the most commonly performed surgery. Screening methods and adjuvant therapy following surgery led to a remarkable decrease in mortality.
Reliable prognostic and predictive markers are needed to guide the selection of the most appropriate adjuvant therapies for individual patients with breast cancer. In fact, a shift from defining the cancer patients who should receive chemotherapy on the basis of their prognostic characteristics to defining the patients who are likely to benefit most from this modality of adjuvant treatment is currently taking place. Understanding the molecular mechanisms underlying the spread of cancer cells to distant organs, therefore, is a prerequisite for the development of novel cancer therapies.
Read the detailed description
Breast cancer is the most common female malignancy worldwide. Despite advances in cancer diagnosis and treatment in recent years, traditional treatments (radiotherapy, chemotherapy, and hormone therapy) are always limited by the resistance of some tumor cells, thus forcing researchers to continue to look for new therapeutic approaches and targets. Soluble resistance-related Calcium-binding protein (Sorcin) is a penta-EF hand calcium binding protein, which participates in the regulation of calcium homeostasis in cells and has molecular mass of 22 kDa. The EF-hand is a common helix-loop-helix structural motif used by proteins to bind calcium. Most proteins are endowed with an even number of EF-hands, which are usually structurally and functionally paired. The penta-EF hand (PEF) family includes sorcin, calpains, programmed cell death protein 6 (PDCD6), peflin and grancalcin.
High sorcin regulates the calcium channels and exchangers located at the plasma membrane and at the endo/sarcoplasmic reticulum (ER/SR) and allows high levels of calcium in the ER to be maintained, preventing ER stress and the unfolded protein response, and increases escape from apoptosis. The 18-kDa variant of sorcin is regulated by Tumor necrosis factor receptor-associated protein 1 (TRAP1), a mitochondrial anti-apoptotic protein upregulated in several human tumors which controls sorcin folding and expression. Conversely, sorcin silencing activates apoptotic proteases as caspase-3 and caspase-12 results in major defects in mitosis and cytokinesis, blocks cell cycle progression in mitosis, increases the number of rounded polynucleated cells and induces apoptosis and cell death shifting the equilibrium between cell life and cell death towards proliferation in MDR cancer cells overexpressing sorcin.
Sorcin is highly expressed in the heart, brain and breast and overexpressed in many cancer cells. The gene for sorcin (SRI) spans about 21.9 kb of human genomic DNA. The gene is located in chromosome 7q21. Sorcin gene is in the same amplicon as other genes involved in the resistance to chemotherapeutics in cancer cells (multi-drug resistance, MDR) such as the ATP-binding cassette (ABC) transporters ABCB4 and ABCB1 (Mdr1, or P-glycoprotein 1).
Annexins are a family of intracellular proteins that bind membrane phospholipids in a Calcium concentration-dependent manner. The human genome encodes for 12 different annexins varying in expression and distribution within the tissues. Some of these are ubiquitously expressed (A1, A2, A5, A6, and A7), while some are selective (A3, A8, A9, A10, and A13). Several annexins play important roles during tumor progression. However, little is known about the clinical implications and biological functions of Annexin A3 (ANXA3) in breast cancer. ANXA3 has a role in cell differentiation, cell migration, immune regulation.
The ANXA3 gene is located on human chromosome 4q13-q22 and encodes a protein of 323 amino acid residues. Annexin A3 participates in various tumor-associated biological processes, including tumor initiation, progression, metastasis and is associated with chemotherapy resistance.
ANXA3 is expressed and secreted by neoplastic mammary cells, and its inhibition halts migration in breast cancer cells. The expression of Annexin A3 in human breast carcinoma closely correlated with tumor size and axillary lymph node metastasis. Elevated serum levels of ANXA3 protein were due to its increased secretion from neoplastic breast cells into the systemic circulation. There is inverse correlation between Annexin A3 expression and overall breast cancer patient survival. Moreover, Annexin A3 might be a novel and potential prognostic marker for patients with breast cancer and is involved in regulating apoptosis by affecting the Bcl-2/Bax balance. It promote the transcription of the anti-apoptotic gene Bcl-2 and downregulate the proapoptotic gene BAX.
- Conditions
- Breast Cancer
- Being tested
- Sorcin gene expression, Annexin A3 serum mesurement
- Keywords
- Breast cancer, SORCIN, Annexin A3
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorcin gene expressionGenetic
Sorcin gene expression Will be measured by real time PCR
Annexin A3 serum mesurementOther
serum mesurement of Annexin A3 by enzyme linked immuno sorbent assay (ELISA)
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients | The present study will be carried on 50 breast cancer patients before surgery.
The followings markers must be estimated:
Sorcin gene expression using real time PCR and Annexin A3 serum mesurement using enzyme linked immuno sorbent assay (ELISA). Receives: Genetic: Sorcin gene expression; Other: Annexin A3 serum mesurement | |
| Healthy controls | The present study will be carried on 15 age and sex matched controls.
The followings markers must be estimated:
Sorcin gene expression using real time PCR and Annexin A3 serum mesurement using ELISA. Receives: Genetic: Sorcin gene expression; Other: Annexin A3 serum mesurement | |
| Benign breast diseases | The present study will be carried on 15 patients with benign breast diseases.
The followings markers must be estimated:
Sorcin gene expression using real time PCR and Annexin A3 serum mesurement using ELISA. Receives: Genetic: Sorcin gene expression; Other: Annexin A3 serum mesurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of SORCIN in patients with breast cancer
genetic expression of SORCIN new biomarker in breast cancer patients
Measured: 1 year
Secondary outcomes (1)
Role of annexin A3 biomarker in with breast cancer patients
serum measurement of annexin A3 in breast cancer patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start20 Jan 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham I El-mahdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598660
- Sponsor's protocol ID
- Breast cancer
- Status last verified
- Jan 2019
- First submitted
- 8 Jul 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeeneldin AA, Ramadan M, Elmashad N, Fakhr I, Diaa A, Mosaad E. Breast cancer laterality among Egyptian patients and its association with treatments and survival. J Egypt Natl Canc Inst. 2013 Dec;25(4):199-207. doi: 10.1016/j.jnci.2013.09.003. Epub 2013 Oct 25.
PubMed 24207092Cubasch H, Joffe M, Ruff P, Dietz D, Rosenbaum E, Murugan N, Chih MT, Ayeni O, Dickens C, Crew K, Jacobson JS, Neugut A. Breast conservation surgery versus total mastectomy among women with localized breast cancer in Soweto, South Africa. PLoS One. 2017 Aug 10;12(8):e0182125. doi: 10.1371/journal.pone.0182125. eCollection 2017.
PubMed 28797046Colotti G, Poser E, Fiorillo A, Genovese I, Chiarini V, Ilari A. Sorcin, a calcium binding protein involved in the multidrug resistance mechanisms in cancer cells. Molecules. 2014 Sep 5;19(9):13976-89. doi: 10.3390/molecules190913976.
PubMed 25197934Kim JY, Jung EJ, Park HJ, Lee JH, Song EJ, Kwag SJ, Park JH, Park T, Jeong SH, Jeong CY, Ju YT, Lee YJ, Hong SC. Tumor-Suppressing Effect of Silencing of Annexin A3 Expression in Breast Cancer. Clin Breast Cancer. 2018 Aug;18(4):e713-e719. doi: 10.1016/j.clbc.2017.11.009. Epub 2017 Nov 21.
PubMed 29217453
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Sorcin and Annexin A3 in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03598660
- Acronym / sponsor ID
- Breast cancer
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, SORCIN, Annexin A3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 26 Jul 2018 (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 (BC) is the most common female malignancy worldwide and the second leading cause of cancer death in women. One in eight women in the United States will develop the illness in their lifetimes. In Egypt, 37.7% of total cancer cases among women is breast cancer. A locally advanced disease is very common and total mastectomy is the most commonly performed surgery. Screening methods and adjuvant therapy following surgery led to a remarkable decrease in mortality.
Reliable prognostic and predictive markers are needed to guide the selection of the most appropriate adjuvant therapies for individual patients with breast cancer. In fact, a shift from defining the cancer patients who should receive chemotherapy on the basis of their prognostic characteristics to defining the patients who are likely to benefit most from this modality of adjuvant treatment is currently taking place. Understanding the molecular mechanisms underlying the spread of cancer cells to distant organs, therefore, is a prerequisite for the development of novel cancer therapies.
Detailed description
Breast cancer is the most common female malignancy worldwide. Despite advances in cancer diagnosis and treatment in recent years, traditional treatments (radiotherapy, chemotherapy, and hormone therapy) are always limited by the resistance of some tumor cells, thus forcing researchers to continue to look for new therapeutic approaches and targets. Soluble resistance-related Calcium-binding protein (Sorcin) is a penta-EF hand calcium binding protein, which participates in the regulation of calcium homeostasis in cells and has molecular mass of 22 kDa. The EF-hand is a common helix-loop-helix structural motif used by proteins to bind calcium. Most proteins are endowed with an even number of EF-hands, which are usually structurally and functionally paired. The penta-EF hand (PEF) family includes sorcin, calpains, programmed cell death protein 6 (PDCD6), peflin and grancalcin.
High sorcin regulates the calcium channels and exchangers located at the plasma membrane and at the endo/sarcoplasmic reticulum (ER/SR) and allows high levels of calcium in the ER to be maintained, preventing ER stress and the unfolded protein response, and increases escape from apoptosis. The 18-kDa variant of sorcin is regulated by Tumor necrosis factor receptor-associated protein 1 (TRAP1), a mitochondrial anti-apoptotic protein upregulated in several human tumors which controls sorcin folding and expression. Conversely, sorcin silencing activates apoptotic proteases as caspase-3 and caspase-12 results in major defects in mitosis and cytokinesis, blocks cell cycle progression in mitosis, increases the number of rounded polynucleated cells and induces apoptosis and cell death shifting the equilibrium between cell life and cell death towards proliferation in MDR cancer cells overexpressing sorcin.
Sorcin is highly expressed in the heart, brain and breast and overexpressed in many cancer cells. The gene for sorcin (SRI) spans about 21.9 kb of human genomic DNA. The gene is located in chromosome 7q21. Sorcin gene is in the same amplicon as other genes involved in the resistance to chemotherapeutics in cancer cells (multi-drug resistance, MDR) such as the ATP-binding cassette (ABC) transporters ABCB4 and ABCB1 (Mdr1, or P-glycoprotein 1).
Annexins are a family of intracellular proteins that bind membrane phospholipids in a Calcium concentration-dependent manner. The human genome encodes for 12 different annexins varying in expression and distribution within the tissues. Some of these are ubiquitously expressed (A1, A2, A5, A6, and A7), while some are selective (A3, A8, A9, A10, and A13). Several annexins play important roles during tumor progression. However, little is known about the clinical implications and biological functions of Annexin A3 (ANXA3) in breast cancer. ANXA3 has a role in cell differentiation, cell migration, immune regulation.
The ANXA3 gene is located on human chromosome 4q13-q22 and encodes a protein of 323 amino acid residues. Annexin A3 participates in various tumor-associated biological processes, including tumor initiation, progression, metastasis and is associated with chemotherapy resistance.
ANXA3 is expressed and secreted by neoplastic mammary cells, and its inhibition halts migration in breast cancer cells. The expression of Annexin A3 in human breast carcinoma closely correlated with tumor size and axillary lymph node metastasis. Elevated serum levels of ANXA3 protein were due to its increased secretion from neoplastic breast cells into the systemic circulation. There is inverse correlation between Annexin A3 expression and overall breast cancer patient survival. Moreover, Annexin A3 might be a novel and potential prognostic marker for patients with breast cancer and is involved in regulating apoptosis by affecting the Bcl-2/Bax balance. It promote the transcription of the anti-apoptotic gene Bcl-2 and downregulate the proapoptotic gene BAX.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | – | Genetic: Sorcin gene expression, Other: Annexin A3 serum mesurementThe present study will be carried on 50 breast cancer patients before surgery. The followings markers must be estimated: Sorcin gene expression using real time PCR and Annexin A3 serum mesurement using enzyme linked immuno sorbent assay (ELISA). |
| Healthy controls | – | Genetic: Sorcin gene expression, Other: Annexin A3 serum mesurementThe present study will be carried on 15 age and sex matched controls. The followings markers must be estimated: Sorcin gene expression using real time PCR and Annexin A3 serum mesurement using ELISA. |
| Benign breast diseases | – | Genetic: Sorcin gene expression, Other: Annexin A3 serum mesurementThe present study will be carried on 15 patients with benign breast diseases. The followings markers must be estimated: Sorcin gene expression using real time PCR and Annexin A3 serum mesurement using ELISA. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- breast cancer patients
Key inclusion criteria (1 listed)
- breast cancer patients before surgery who are admitted to the South Egypt Cancer Institute, Surgery Department, Assiut University
Key exclusion criteria (5 listed)
- • Patients with malignancies elsewhere in the body.
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 |
|---|---|---|
| Sorcin gene expressionSorcin gene expression Will be measured by real time PCR | Genetic | Benign breast diseases, Breast cancer patients, Healthy controls |
| Annexin A3 serum mesurementserum mesurement of Annexin A3 by enzyme linked immuno sorbent assay (ELISA) | Other | Benign breast diseases, Breast cancer patients, Healthy controls |
Primary outcome
Role of SORCIN in patients with breast cancer
Time frame: 1 year
genetic expression of SORCIN new biomarker in breast cancer patients
1 secondary outcome
Role of annexin A3 biomarker in with breast cancer patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Background: PubMed 24207092Zeeneldin AA, Ramadan M, Elmashad N, Fakhr I, Diaa A, Mosaad E. Breast cancer laterality among Egyptian patients and its association with treatments and survival. J Egypt Natl Canc Inst. 2013 Dec;25(4):199-207. doi: 10.1016/j.jnci.2013.09.003. Epub 2013 Oct 25.
- Background: PubMed 28797046Cubasch H, Joffe M, Ruff P, Dietz D, Rosenbaum E, Murugan N, Chih MT, Ayeni O, Dickens C, Crew K, Jacobson JS, Neugut A. Breast conservation surgery versus total mastectomy among women with localized breast cancer in Soweto, South Africa. PLoS One. 2017 Aug 10;12(8):e0182125. doi: 10.1371/journal.pone.0182125. eCollection 2017.
- Background: PubMed 25197934Colotti G, Poser E, Fiorillo A, Genovese I, Chiarini V, Ilari A. Sorcin, a calcium binding protein involved in the multidrug resistance mechanisms in cancer cells. Molecules. 2014 Sep 5;19(9):13976-89. doi: 10.3390/molecules190913976.
- Background: PubMed 29217453Kim JY, Jung EJ, Park HJ, Lee JH, Song EJ, Kwag SJ, Park JH, Park T, Jeong SH, Jeong CY, Ju YT, Lee YJ, Hong SC. Tumor-Suppressing Effect of Silencing of Annexin A3 Expression in Breast Cancer. Clin Breast Cancer. 2018 Aug;18(4):e713-e719. doi: 10.1016/j.clbc.2017.11.009. Epub 2017 Nov 21.
- Individual participant dataSharing planned: No
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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?
An observational study of 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 5 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 9 Jan 2019. 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. 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 reham elmahdy (+201002714637, reham.elmahdy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of SORCIN in patients with breast cancer (time frame: 1 year). 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 NCT03598660, which also lists 4 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 9 Jan 2019.