NCT03598660

Brief Summary

Breast cancer (BC) is the most common female malignancy worldwide and the second leading cause of cancer death in women. One in eight women in the United States will develop the illness in their lifetimes. In Egypt, 37.7% of total cancer cases among women is breast cancer. A locally advanced disease is very common and total mastectomy is the most commonly performed surgery. Screening methods and adjuvant therapy following surgery led to a remarkable decrease in mortality. Reliable prognostic and predictive markers are needed to guide the selection of the most appropriate adjuvant therapies for individual patients with breast cancer. In fact, a shift from defining the cancer patients who should receive chemotherapy on the basis of their prognostic characteristics to defining the patients who are likely to benefit most from this modality of adjuvant treatment is currently taking place. Understanding the molecular mechanisms underlying the spread of cancer cells to distant organs, therefore, is a prerequisite for the development of novel cancer therapies.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 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

July 8, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

January 20, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

July 8, 2018

Last Update Submit

January 8, 2019

Conditions

Keywords

Breast cancer, SORCIN, Annexin A3

Outcome Measures

Primary Outcomes (1)

  • Role of SORCIN in patients with breast cancer

    genetic expression of SORCIN new biomarker in breast cancer patients

    1 year

Secondary Outcomes (1)

  • Role of annexin A3 biomarker in with breast cancer patients

    1 year

Study Arms (3)

Breast cancer patients

The present study will be carried on 50 breast cancer patients before surgery. The followings markers must be estimated: Sorcin gene expression using real time PCR and Annexin A3 serum mesurement using enzyme linked immuno sorbent assay (ELISA).

Genetic: Sorcin gene expressionOther: Annexin A3 serum mesurement

Healthy controls

The present study will be carried on 15 age and sex matched controls. The followings markers must be estimated: Sorcin gene expression using real time PCR and Annexin A3 serum mesurement using ELISA.

Genetic: Sorcin gene expressionOther: Annexin A3 serum mesurement

Benign breast diseases

The present study will be carried on 15 patients with benign breast diseases. The followings markers must be estimated: Sorcin gene expression using real time PCR and Annexin A3 serum mesurement using ELISA.

Genetic: Sorcin gene expressionOther: Annexin A3 serum mesurement

Interventions

Sorcin gene expression Will be measured by real time PCR

Benign breast diseasesBreast cancer patientsHealthy controls

serum mesurement of Annexin A3 by enzyme linked immuno sorbent assay (ELISA)

Benign breast diseasesBreast cancer patientsHealthy controls

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

breast cancer patients

You may qualify if:

  • breast cancer patients before surgery who are admitted to the South Egypt Cancer Institute, Surgery Department, Assiut University

You may not qualify if:

  • Patients with malignancies elsewhere in the body.
  • Patients with chronic cardiac diseases.
  • Getting neoadjuvant chemotherapy.
  • Renal disease.
  • Neurodegenerative disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Zeeneldin AA, Ramadan M, Elmashad N, Fakhr I, Diaa A, Mosaad E. Breast cancer laterality among Egyptian patients and its association with treatments and survival. J Egypt Natl Canc Inst. 2013 Dec;25(4):199-207. doi: 10.1016/j.jnci.2013.09.003. Epub 2013 Oct 25.

    PMID: 24207092BACKGROUND
  • Cubasch H, Joffe M, Ruff P, Dietz D, Rosenbaum E, Murugan N, Chih MT, Ayeni O, Dickens C, Crew K, Jacobson JS, Neugut A. Breast conservation surgery versus total mastectomy among women with localized breast cancer in Soweto, South Africa. PLoS One. 2017 Aug 10;12(8):e0182125. doi: 10.1371/journal.pone.0182125. eCollection 2017.

    PMID: 28797046BACKGROUND
  • Colotti G, Poser E, Fiorillo A, Genovese I, Chiarini V, Ilari A. Sorcin, a calcium binding protein involved in the multidrug resistance mechanisms in cancer cells. Molecules. 2014 Sep 5;19(9):13976-89. doi: 10.3390/molecules190913976.

    PMID: 25197934BACKGROUND
  • Kim JY, Jung EJ, Park HJ, Lee JH, Song EJ, Kwag SJ, Park JH, Park T, Jeong SH, Jeong CY, Ju YT, Lee YJ, Hong SC. Tumor-Suppressing Effect of Silencing of Annexin A3 Expression in Breast Cancer. Clin Breast Cancer. 2018 Aug;18(4):e713-e719. doi: 10.1016/j.clbc.2017.11.009. Epub 2017 Nov 21.

    PMID: 29217453BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

July 8, 2018

First Posted

July 26, 2018

Study Start

January 20, 2019

Primary Completion

August 1, 2019

Study Completion

September 30, 2019

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share