NCT04720508

Brief Summary

In this study we aim to:

  1. 1.Assess serum miRNA-373, miRNA-425-5p expression in patients with breast cancer.
  2. 2.Explore their correlations with breast cancer clinicopathological documented data including staging, grading and tumor receptors.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

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

January 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

January 19, 2021

Last Update Submit

January 21, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Assess serum miRNA-373 and miRNA-425-5p expression in patients with breast cancer.

    compare level of serum miRNA-373 and miRNA-425-5p expression in breast cancer patients with that of normal control in aim to help in diagnosis of BC patients and staging them

    baseline

Secondary Outcomes (1)

  • Explore correlations of serum miRNA-373 and miRNA-425-5p expression in breast cancer patients with clinicopathological documented data including staging, grading and tumor receptors.

    baseline

Study Arms (2)

Group A (patient group)

included 25 patients with BC admitted to department of medical Oncology, South Egypt Cancer Institute, Assiut University. blood samples will be obtained after getting informed consent.

Diagnostic Test: blood sample collection.

Group B (control group)

included 25 controls age-matched , sex-matched and apparently healthy. blood samples will be obtained after getting informed consent .

Diagnostic Test: blood sample collection.

Interventions

blood sample collection.DIAGNOSTIC_TEST

venipuncture procedure

Group A (patient group)Group B (control group)

Eligibility Criteria

Age20 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a case control hospital-based study will conduct on women divided into two groups: Group A (patient group) : included patients with BC admitted to department of medical Oncology, South Egypt Cancer Institute, Assiut University. Whereas, Group B (control group) : included controls age-matched , sex-matched and apparently healthy.

You may qualify if:

  • Female age 20 years or older
  • documented diagnosis of breast cancer based on physical examination, imaging and histopathology
  • possibility of obtaining blood samples from the subject.

You may not qualify if:

  • All patients with prior history of exposure to chemotherapy, radiotherapy or hormonal therapy .
  • patients with other malignancies.
  • patients with chronic inflammatory diseases.
  • patients with missed documentation for histopathological diagnosis of breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.

    PMID: 25328522BACKGROUND

  • Yalcin B. Staging, risk assessment and screening of breast cancer. Exp Oncol. 2013 Dec;35(4):238-45.

    PMID: 24382431BACKGROUND

  • Autier P, Boniol M. Mammography screening: A major issue in medicine. Eur J Cancer. 2018 Feb;90:34-62. doi: 10.1016/j.ejca.2017.11.002. Epub 2017 Dec 20.

    PMID: 29272783BACKGROUND

  • Matsen CB, Neumayer LA. Breast cancer: a review for the general surgeon. JAMA Surg. 2013 Oct;148(10):971-9. doi: 10.1001/jamasurg.2013.3393.

    PMID: 23986370BACKGROUND

  • Aalami AH, Pouresmaeil V, Amirabadi A, Mojahed FH, Rad MQ, Sahebkar A. Evaluation of the Diagnostic Properties of Serum hsa-miR-223-5p in the Detection of Gastric Cancer: A Case-Control Study. Anticancer Agents Med Chem. 2020;20(7):800-808. doi: 10.2174/1871520620666200204100602.

    PMID: 32013852BACKGROUND

  • Zhou Y, Sheng B, Xia Q, Guan X, Zhang Y. Association of long non-coding RNA H19 and microRNA-21 expression with the biological features and prognosis of non-small cell lung cancer. Cancer Gene Ther. 2017 Aug;24(8):317-324. doi: 10.1038/cgt.2017.20. Epub 2017 Aug 11.

    PMID: 28799568BACKGROUND

  • Eichelser C, Flesch-Janys D, Chang-Claude J, Pantel K, Schwarzenbach H. Deregulated serum concentrations of circulating cell-free microRNAs miR-17, miR-34a, miR-155, and miR-373 in human breast cancer development and progression. Clin Chem. 2013 Oct;59(10):1489-96. doi: 10.1373/clinchem.2013.205161. Epub 2013 Jun 7.

    PMID: 23748853BACKGROUND

  • Mangolini A, Ferracin M, Zanzi MV, Saccenti E, Ebnaof SO, Poma VV, Sanz JM, Passaro A, Pedriali M, Frassoldati A, Querzoli P, Sabbioni S, Carcoforo P, Hollingsworth A, Negrini M. Diagnostic and prognostic microRNAs in the serum of breast cancer patients measured by droplet digital PCR. Biomark Res. 2015 Jun 6;3:12. doi: 10.1186/s40364-015-0037-0. eCollection 2015.

    PMID: 26120471BACKGROUND

  • Zhang LF, Zhang JG, Zhou H, Dai TT, Guo FB, Xu SY, Chen Y. MicroRNA-425-5p promotes breast cancer cell growth by inducing PI3K/AKT signaling. Kaohsiung J Med Sci. 2020 Apr;36(4):250-256. doi: 10.1002/kjm2.12148. Epub 2019 Nov 5.

    PMID: 31688991BACKGROUND

  • Huang Q, Gumireddy K, Schrier M, le Sage C, Nagel R, Nair S, Egan DA, Li A, Huang G, Klein-Szanto AJ, Gimotty PA, Katsaros D, Coukos G, Zhang L, Pure E, Agami R. The microRNAs miR-373 and miR-520c promote tumour invasion and metastasis. Nat Cell Biol. 2008 Feb;10(2):202-10. doi: 10.1038/ncb1681. Epub 2008 Jan 13.

    PMID: 18193036BACKGROUND

  • Inns J, James V. Circulating microRNAs for the prediction of metastasis in breast cancer patients diagnosed with early stage disease. Breast. 2015 Aug;24(4):364-9. doi: 10.1016/j.breast.2015.04.001. Epub 2015 May 6.

    PMID: 25957467BACKGROUND

  • Pimentel F, Bonilla P, Ravishankar YG, Contag A, Gopal N, LaCour S, Lee T, Niemz A. Technology in MicroRNA Profiling: Circulating MicroRNAs as Noninvasive Cancer Biomarkers in Breast Cancer. J Lab Autom. 2015 Oct;20(5):574-88. doi: 10.1177/2211068214561788. Epub 2014 Dec 18.

    PMID: 25524488BACKGROUND

  • Hosseini Mojahed F, Aalami AH, Pouresmaeil V, Amirabadi A, Qasemi Rad M, Sahebkar A. Clinical Evaluation of the Diagnostic Role of MicroRNA-155 in Breast Cancer. Int J Genomics. 2020 Sep 7;2020:9514831. doi: 10.1155/2020/9514831. eCollection 2020.

    PMID: 32964011BACKGROUND

  • Swellam M, El Magdoub HM, Hassan NM, Hefny MM, Sobeih ME. Potential diagnostic role of circulating MiRNAs in breast cancer: Implications on clinicopathological characters. Clin Biochem. 2018 Jun;56:47-54. doi: 10.1016/j.clinbiochem.2018.04.013. Epub 2018 Apr 19.

    PMID: 29679553BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Hosam Atif Anas

CONTACT

01113483821hosamanas94@gmail.com

Hebatallah Ismail Hassan

CONTACT

01118433083heba.ismailhassan@gmail.com

Study Design

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

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 22, 2021

Study Start

December 1, 2021

Primary Completion

October 25, 2023

Study Completion

December 25, 2023

Last Updated

January 22, 2021

Record last verified: 2021-01