NCT04093609

Brief Summary

Very little is known about the role of X-inactive specific transcript RNA in human breast cancer and in regulating different response to therapy . the relation between the breast cancer predisposing gene BRCA1 \& X-inactive specific transcript RNA has been investigated but still controversial. Loss of X chromosome inactivation (XCI) is observed in breast cancer . Other studies sheds light on a possible mechanism of breast carcinogenesis mediated by XIST misbehaviour.

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
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

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

September 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 16, 2019

Last Update Submit

September 16, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • detection of X inactive specific transcript RNA deletion in patients with breast cancer

    detection of X inactive specific transcript RNA deletion by fluorescence in situ hybridization in patients with breast cancer and its relation with different response to therapies

    3 years

Study Arms (2)

cases

Genetic: XIST gene deletion

control

Genetic: XIST gene deletion

Interventions

XIST gene deletionGENETIC

detection of XIST gene deletion by fluorescence in situ hybridization

casescontrol

Eligibility Criteria

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

Newly diagnosed female patients of breast cancer admitted to south egypt cancer institute above age of 20 years at different stages of the disease

You may qualify if:

  • Newly diagnosed patients of breast cancer admitted to south egypt cancer institute at different stages of the disease

You may not qualify if:

  • Other malignant diseases. Male breast cancer . Female with other sex linked diseases . Patients received chemotherapy for breast cancer .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Lima ZS, Ghadamzadeh M, Arashloo FT, Amjad G, Ebadi MR, Younesi L. Recent advances of therapeutic targets based on the molecular signature in breast cancer: genetic mutations and implications for current treatment paradigms. J Hematol Oncol. 2019 Apr 11;12(1):38. doi: 10.1186/s13045-019-0725-6.

    PMID: 30975222BACKGROUND

  • Akram M, Iqbal M, Daniyal M, Khan AU. Awareness and current knowledge of breast cancer. Biol Res. 2017 Oct 2;50(1):33. doi: 10.1186/s40659-017-0140-9.

    PMID: 28969709BACKGROUND

  • Yue M, Charles Richard JL, Yamada N, Ogawa A, Ogawa Y. Quick fluorescent in situ hybridization protocol for Xist RNA combined with immunofluorescence of histone modification in X-chromosome inactivation. J Vis Exp. 2014 Nov 26;(93):e52053. doi: 10.3791/52053.

    PMID: 25489864BACKGROUND

  • Giudice A, Barbieri A, Bimonte S, Cascella M, Cuomo A, Crispo A, D'Arena G, Galdiero M, Della Pepa ME, Botti G, Caraglia M, Capunzo M, Arra C, Montella M. Dissecting the prevention of estrogen-dependent breast carcinogenesis through Nrf2-dependent and independent mechanisms. Onco Targets Ther. 2019 Jun 24;12:4937-4953. doi: 10.2147/OTT.S183192. eCollection 2019.

    PMID: 31388303BACKGROUND

  • Banin Hirata BK, Oda JM, Losi Guembarovski R, Ariza CB, de Oliveira CE, Watanabe MA. Molecular markers for breast cancer: prediction on tumor behavior. Dis Markers. 2014;2014:513158. doi: 10.1155/2014/513158. Epub 2014 Jan 28.

    PMID: 24591761BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Eman Mosaad Zaki, PhD

CONTACT

00201065518821Eman_mosaad@hotmail.com

Engy Adel Shafik, PhD

CONTACT

00201223809172engyadelshafik@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 18, 2019

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2022

Last Updated

September 18, 2019

Record last verified: 2019-09