Breast CancerNCT05876728
Role of Irisin/FNDC5 (rs3480) Single Nucleotide Polymorphism in Breast Cancer
An observational study of Breast Cancer, run by Sohag University at 1 site in Egypt.
Trial summary
Breast cancer is the most frequent cancer in women worldwide. Its incidence is increasing but mortality has decreased in a considerable way due to the combined effect of early detection and improvement in treatment . Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Genotyping
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jun 2024
- 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 70 years
- All sexes
- Adult, Older adult
Study population: A Case control study will be conducted on 100 patients with histologically confirmed breast cancer, and a control group of 50 healthy volunteers with no clinical evidence of any neoplastic disorder.
Who may be able to join
- histologically confirmed breast cancer
Who cannot join
- • History of other tumors.
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer is the most frequent cancer in women worldwide. Its incidence is increasing but mortality has decreased in a considerable way due to the combined effect of early detection and improvement in treatment .
Irisin is encoded by the FNDC5 gene, whose expression is controlled by the peroxi- some proliferator activated receptor gamma coactivator 1 alpha (PGC-1α). PGC-1α is a transcriptional co-activator which does not bind directly to DNA. Studies indicated that the estrogen-related receptor alpha (ERRα) could be a factor that plays a role in PGC-1α binding to DNA. ERRα is encoded by the ESRRA gene and is an orphan nuclear receptor, which has two domains. One of them allows the interaction with DNA, and the second one with a ligand. The ERRα structure is similar to that of the estrogen receptor alpha (ERα), but this receptor does not bind to natural estrogens. ERRα interacts with a canonical sequence of the estrogen response elements (ERRE). ERRα and ERα could compete with each other to bind to similar DNA elements. Together, ERRα binds to DNA, in complex with PGC-1α, to regulate the activity of genes such as FNDC5 .
CA15-3, a high molecular weight glycoprotein (300-450 kDa), is produced by the epithelial ducts and acinic breast cells and is then secreted in milk normally. It has been widely used for the prediction of bone metastases in patients with breast cancer .
- Conditions
- Breast Cancer
- Being tested
- Genotyping
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenotypingGenetic
Genotyping of rs 3480 of irisin gene using the Taqman Allelic Discrimination assay technique.
| Study group | Role | What they receive |
|---|---|---|
| cases group | 50 patient of histologically confirmed breast cancer Receives: Genetic: Genotyping | |
| control group | 50 healthy volunteers with no clinical evidence of any neoplastic disorder Receives: Genetic: Genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
find a possible association between irisin gene single nucleotide polymorphism with breast cancer
- find a possible association between irisin gene single nucleotide polymorphism with breast cancer risk and the distribution of its alleles, in relation to many clinical parameters of the cancer group.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (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 Sohag 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Badway Hemdan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876728
- Sponsor's protocol ID
- Soh-Med-23-04-10PD
- Status last verified
- May 2023
- First submitted
- 17 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Peto R, Boreham J, Clarke M, Davies C, Beral V. UK and USA breast cancer deaths down 25% in year 2000 at ages 20-69 years. Lancet. 2000 May 20;355(9217):1822. doi: 10.1016/S0140-6736(00)02277-7. No abstract available.
PubMed 10832853Balmain A, Gray J, Ponder B. The genetics and genomics of cancer. Nat Genet. 2003 Mar;33 Suppl:238-44. doi: 10.1038/ng1107.
PubMed 12610533Nowinska K, Jablonska K, Ciesielska U, Piotrowska A, Haczkiewicz-Lesniak K, Pawelczyk K, Podhorska-Okolow M, Dziegiel P. Association of Irisin/FNDC5 with ERRalpha and PGC-1alpha Expression in NSCLC. Int J Mol Sci. 2022 Nov 17;23(22):14204. doi: 10.3390/ijms232214204.
PubMed 36430689Fakhari A, Gharepapagh E, Dabiri S, Gilani N. Correlation of cancer antigen 15-3 (CA15-3) serum level and bony metastases in breast cancer patients. Med J Islam Repub Iran. 2019 Dec 19;33:142. doi: 10.34171/mjiri.33.142. eCollection 2019.
PubMed 32280648
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Irisin/FNDC5 (rs3480) Single Nucleotide Polymorphism in Breast Cancer
- ClinicalTrials.gov ID
- NCT05876728
- Acronym / sponsor ID
- Soh-Med-23-04-10PD
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 25 May 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.
Breast cancer is the most frequent cancer in women worldwide. Its incidence is increasing but mortality has decreased in a considerable way due to the combined effect of early detection and improvement in treatment .
Irisin is encoded by the FNDC5 gene, whose expression is controlled by the peroxi- some proliferator activated receptor gamma coactivator 1 alpha (PGC-1α). PGC-1α is a transcriptional co-activator which does not bind directly to DNA. Studies indicated that the estrogen-related receptor alpha (ERRα) could be a factor that plays a role in PGC-1α binding to DNA. ERRα is encoded by the ESRRA gene and is an orphan nuclear receptor, which has two domains. One of them allows the interaction with DNA, and the second one with a ligand. The ERRα structure is similar to that of the estrogen receptor alpha (ERα), but this receptor does not bind to natural estrogens. ERRα interacts with a canonical sequence of the estrogen response elements (ERRE). ERRα and ERα could compete with each other to bind to similar DNA elements. Together, ERRα binds to DNA, in complex with PGC-1α, to regulate the activity of genes such as FNDC5 .
CA15-3, a high molecular weight glycoprotein (300-450 kDa), is produced by the epithelial ducts and acinic breast cells and is then secreted in milk normally. It has been widely used for the prediction of bone metastases in patients with breast cancer .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases group | – | Genetic: Genotyping50 patient of histologically confirmed breast cancer |
| control group | – | Genetic: Genotyping50 healthy volunteers with no clinical evidence of any neoplastic disorder |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A Case control study will be conducted on 100 patients with histologically confirmed breast cancer, and a control group of 50 healthy volunteers with no clinical evidence of any neoplastic disorder.
Key inclusion criteria (1 listed)
- histologically confirmed breast cancer
Key exclusion criteria (1 listed)
- • History of other tumors.
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 |
|---|---|---|
| GenotypingGenotyping of rs 3480 of irisin gene using the Taqman Allelic Discrimination assay technique. | Genetic | cases group, control group |
Primary outcome
find a possible association between irisin gene single nucleotide polymorphism with breast cancer
Time frame: 12 months
- find a possible association between irisin gene single nucleotide polymorphism with breast cancer risk and the distribution of its alleles, in relation to many clinical parameters of the cancer group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Background: PubMed 10832853Peto R, Boreham J, Clarke M, Davies C, Beral V. UK and USA breast cancer deaths down 25% in year 2000 at ages 20-69 years. Lancet. 2000 May 20;355(9217):1822. doi: 10.1016/S0140-6736(00)02277-7. No abstract available.
- Background: PubMed 12610533Balmain A, Gray J, Ponder B. The genetics and genomics of cancer. Nat Genet. 2003 Mar;33 Suppl:238-44. doi: 10.1038/ng1107.
- Background: PubMed 36430689Nowinska K, Jablonska K, Ciesielska U, Piotrowska A, Haczkiewicz-Lesniak K, Pawelczyk K, Podhorska-Okolow M, Dziegiel P. Association of Irisin/FNDC5 with ERRalpha and PGC-1alpha Expression in NSCLC. Int J Mol Sci. 2022 Nov 17;23(22):14204. doi: 10.3390/ijms232214204.
- Background: PubMed 32280648Fakhari A, Gharepapagh E, Dabiri S, Gilani N. Correlation of cancer antigen 15-3 (CA15-3) serum level and bony metastases in breast cancer patients. Med J Islam Repub Iran. 2019 Dec 19;33:142. doi: 10.34171/mjiri.33.142. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sohag University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 25 May 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 Egypt. 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. 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 Shimaa B Hemdan, lecturer (01115894759, shimaabadwy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
find a possible association between irisin gene single nucleotide polymorphism with breast cancer (time frame: 12 months). 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 NCT05876728, 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 25 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.