NCT06357689

Brief Summary

Long non-coding RNAs (lncRNAs) play an important role in different types of cancer, including breast cancer, through regulation of gene expression and epigenetic signatures. Genetic variations such as single nucleotide polymorphisms (SNPs) in lncRNAs have been found to be associated with cancer. Our aim was to provide information about the role of LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859, rs4432291 and rs1558535) in breast cancer susceptibility in the Egyptian population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
417

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

October 24, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1.4 years

First QC Date

March 31, 2024

Last Update Submit

April 4, 2024

Conditions

Breast Cancer

Keywords

lncRNALincRNALINC00511SNPsBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Investigating the relationship of the genotypes of each SNP of the LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) with either increased or decreased risk of breast cancer or no effect in the Egyptian population

    By using Taqman SNP genotyping assay

    two years

Secondary Outcomes (6)

  • Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and Estrogen receptor

    Two months

  • Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and Progesterone receptor

    Two months

  • Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and HER2 status

    Two months

  • Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and tumor stage

    Two months

  • Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and tumor grade

    Two months

  • +1 more secondary outcomes

Study Arms (2)

Breast cancer Cases

Histopathologically confirmed primary female breast cancer patients with age group (20-70 years)

Controls

Healthy female volunteers not suffering from any disease

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale cases and controls to find out the association of their data with female breast cancer.
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female Egyptian breast cancer patients were enrolled from National cancer institute (NCI), Cairo, Egypt after confirmed diagnosis.

You may qualify if:

  • Histopathologically confirmed primary BC patients
  • Age group (Adult female BC patients 20-70 years)

You may not qualify if:

  • Patients suffering from any cancer other than BC
  • Females of age less than 20 or more than 70
  • Patients with incomplete histopathology diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of pharmacy, Ain Shams University, Advanced Biochemisrty Research Lab

Cairo, Egypt

Location

Faculty of Pharmacy, The British University in Egypt, Pharmacology and Biochemistry Research lab

Cairo, Egypt

Location

Related Publications (17)

  • Thorat MA, Balasubramanian R. Breast cancer prevention in high-risk women. Best Pract Res Clin Obstet Gynaecol. 2020 May;65:18-31. doi: 10.1016/j.bpobgyn.2019.11.006. Epub 2019 Nov 21.

    PMID: 31862315BACKGROUND

  • Wu B, Yuan Y, Han X, Wang Q, Shang H, Liang X, Jing H, Cheng W. Structure of LINC00511-siRNA-conjugated nanobubbles and improvement of cisplatin sensitivity on triple negative breast cancer. FASEB J. 2020 Jul;34(7):9713-9726. doi: 10.1096/fj.202000481R. Epub 2020 Jun 4.

    PMID: 32497336BACKGROUND

  • Manzour AF, Gamal Eldin DA. Awareness about breast cancer and mammogram among women attending outpatient clinics, Ain Shams University Hospitals, Egypt. J Egypt Public Health Assoc. 2019 Dec 4;94(1):26. doi: 10.1186/s42506-019-0026-5.

    PMID: 32813088BACKGROUND

  • Eliyatkin N, Yalcin E, Zengel B, Aktas S, Vardar E. Molecular Classification of Breast Carcinoma: From Traditional, Old-Fashioned Way to A New Age, and A New Way. J Breast Health. 2015 Apr 1;11(2):59-66. doi: 10.5152/tjbh.2015.1669. eCollection 2015 Apr.

    PMID: 28331693BACKGROUND

  • Park JH, Ahn JH, Kim SB. How shall we treat early triple-negative breast cancer (TNBC): from the current standard to upcoming immuno-molecular strategies. ESMO Open. 2018 May 3;3(Suppl 1):e000357. doi: 10.1136/esmoopen-2018-000357. eCollection 2018.

    PMID: 29765774BACKGROUND

  • Sun YS, Zhao Z, Yang ZN, Xu F, Lu HJ, Zhu ZY, Shi W, Jiang J, Yao PP, Zhu HP. Risk Factors and Preventions of Breast Cancer. Int J Biol Sci. 2017 Nov 1;13(11):1387-1397. doi: 10.7150/ijbs.21635. eCollection 2017.

    PMID: 29209143BACKGROUND

  • He Y, Liu H, Chen Q, Shao Y, Luo S. Relationships between SNPs and prognosis of breast cancer and pathogenic mechanism. Mol Genet Genomic Med. 2019 Sep;7(9):e871. doi: 10.1002/mgg3.871. Epub 2019 Jul 17.

    PMID: 31317673BACKGROUND

  • Xiu B, Chi Y, Liu L, Chi W, Zhang Q, Chen J, Guo R, Si J, Li L, Xue J, Shao ZM, Wu ZH, Huang S, Wu J. LINC02273 drives breast cancer metastasis by epigenetically increasing AGR2 transcription. Mol Cancer. 2019 Dec 19;18(1):187. doi: 10.1186/s12943-019-1115-y.

    PMID: 31856843BACKGROUND

  • Xu S, Kong D, Chen Q, Ping Y, Pang D. Oncogenic long noncoding RNA landscape in breast cancer. Mol Cancer. 2017 Jul 24;16(1):129. doi: 10.1186/s12943-017-0696-6.

    PMID: 28738804BACKGROUND

  • Arun G, Spector DL. MALAT1 long non-coding RNA and breast cancer. RNA Biol. 2019 Jun;16(6):860-863. doi: 10.1080/15476286.2019.1592072. Epub 2019 Mar 22.

    PMID: 30874469BACKGROUND

  • Zhang T, Hu H, Yan G, Wu T, Liu S, Chen W, Ning Y, Lu Z. Long Non-Coding RNA and Breast Cancer. Technol Cancer Res Treat. 2019 Jan 1;18:1533033819843889. doi: 10.1177/1533033819843889.

    PMID: 30983509BACKGROUND

  • Du X, Tu Y, Liu S, Zhao P, Bao Z, Li C, Li J, Pan M, Ji J. LINC00511 contributes to glioblastoma tumorigenesis and epithelial-mesenchymal transition via LINC00511/miR-524-5p/YB1/ZEB1 positive feedback loop. J Cell Mol Med. 2020 Jan;24(2):1474-1487. doi: 10.1111/jcmm.14829. Epub 2019 Dec 19.

    PMID: 31856394BACKGROUND

  • Ghafouri-Fard S, Safarzadeh A, Hussen BM, Taheri M, Ayatollahi SA. A review on the role of LINC00511 in cancer. Front Genet. 2023 Apr 14;14:1116445. doi: 10.3389/fgene.2023.1116445. eCollection 2023.

    PMID: 37124625BACKGROUND

  • Eldash S, Sanad EF, Nada D, Hamdy NM. The Intergenic Type LncRNA (LINC RNA) Faces in Cancer with In Silico Scope and a Directed Lens to LINC00511: A Step toward ncRNA Precision. Noncoding RNA. 2023 Sep 25;9(5):58. doi: 10.3390/ncrna9050058.

    PMID: 37888204BACKGROUND

  • Lu G, Li Y, Ma Y, Lu J, Chen Y, Jiang Q, Qin Q, Zhao L, Huang Q, Luo Z, Huang S, Wei Z. Long noncoding RNA LINC00511 contributes to breast cancer tumourigenesis and stemness by inducing the miR-185-3p/E2F1/Nanog axis. J Exp Clin Cancer Res. 2018 Nov 27;37(1):289. doi: 10.1186/s13046-018-0945-6.

    PMID: 30482236BACKGROUND

  • Xu T, Hu XX, Liu XX, Wang HJ, Lin K, Pan YQ, Sun HL, Peng HX, Chen XX, Wang SK, He BS. Association between SNPs in Long Non-coding RNAs and the Risk of Female Breast Cancer in a Chinese Population. J Cancer. 2017 Apr 9;8(7):1162-1169. doi: 10.7150/jca.18055. eCollection 2017.

    PMID: 28607590BACKGROUND

  • Cui P, Zhao Y, Chu X, He N, Zheng H, Han J, Song F, Chen K. SNP rs2071095 in LincRNA H19 is associated with breast cancer risk. Breast Cancer Res Treat. 2018 Aug;171(1):161-171. doi: 10.1007/s10549-018-4814-y. Epub 2018 May 8.

    PMID: 29737472BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Five milliliters of blood were collected from controls and BC patients into EDTA anticoagulant vacutainers and stored at -20º C until biochemical assessment.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nadia Hamdy, PhD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2024

First Posted

April 10, 2024

Study Start

October 24, 2021

Primary Completion

March 11, 2023

Study Completion

April 29, 2023

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

EG(2)