NCT05876728

Brief 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 . 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 .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

May 17, 2023

Last Update Submit

May 17, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Study Arms (2)

cases group

50 patient of histologically confirmed breast cancer

Genetic: Genotyping

control group

50 healthy volunteers with no clinical evidence of any neoplastic disorder

Genetic: Genotyping

Interventions

GenotypingGENETIC

Genotyping of rs 3480 of irisin gene using the Taqman Allelic Discrimination assay technique.

cases groupcontrol group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • histologically confirmed breast cancer

You may not qualify if:

  • History of other tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 10832853BACKGROUND

  • Balmain A, Gray J, Ponder B. The genetics and genomics of cancer. Nat Genet. 2003 Mar;33 Suppl:238-44. doi: 10.1038/ng1107.

    PMID: 12610533BACKGROUND

  • Nowinska 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.

    PMID: 36430689BACKGROUND

  • Fakhari 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.

    PMID: 32280648BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Genotype

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Central Study Contacts

Shimaa B Hemdan, lecturer

CONTACT

01115894759shimaabadwy@med.sohag.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of medical biochemistry

Study Record Dates

First Submitted

May 17, 2023

First Posted

May 25, 2023

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

May 25, 2023

Record last verified: 2023-05

Locations

EG(1)