Role of Irisin/FNDC5 (rs3480) Single Nucleotide Polymorphism in Breast Cancer

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05876728
Collaborator
(none)
100
1
12
8.3

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Genetic: Genotyping

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Role of Irisin/FNDC5 (rs3480) Single Nucleotide Polymorphism in Breast Cancer
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
cases group

50 patient of histologically confirmed breast cancer

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

control group

50 healthy volunteers with no clinical evidence of any neoplastic disorder

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

Outcome Measures

Primary Outcome Measures

  1. find a possible association between irisin gene single nucleotide polymorphism with breast cancer [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • histologically confirmed breast cancer
Exclusion Criteria:
  • • History of other tumors.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag university Hospital Sohag Egypt Sohag

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shimaa Badway Hemdan, lecturer of medical biochemistry, Sohag University
ClinicalTrials.gov Identifier:
NCT05876728
Other Study ID Numbers:
  • Soh-Med-23-04-10PD
First Posted:
May 25, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2023