XIST Gene Deletion in Breast Cancer Therapy | NCT04093609

Studies
XIST Gene Deletion in Breast Cancer Therapy

NCT04093609

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Sep 18, 2019Actual

Enrollment

1Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

XIST gene deletion

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Estimated

Primary Completion Date

Mar 1, 2021Estimated

Completion Date

Mar 1, 2022Estimated

First Submitted Date

Sep 16, 2019

First Submission Date that Met QC Criteria

Sep 16, 2019

First Posted Date

Sep 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2019

Last Update Posted Date

Sep 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

breast cancer is an important cause of morbidity and mortality in women .Genetics of female contributes to her risk of having breast cancer . this disease is still discovered in their late stages due to the negligence of females inspite of self inspection and clinical examination of the breast .the identification of markers that could predict the tumor behavior is important in breast cancer management , staging, evaluation of therapeutic response and development of new therapeutic modalities .XIST (X-inactive specific transcript) RNA is a long non -coding RNA which plays an important role in inactivation of x_ chromosome which act as an example for long non _ coding RNA mediated gene regulation .Very little is known about the role of XIST in human breast cancer and in regulating different response on therapy . the relation between the breast cancer predisposing gene BRCA1 & XIST has been investigated but still controversial .Loss of X chromosome inactivation (XCI) is observed in breast . some studies provide evedience that BRCA1 Is involved in XIST regulation on the active X chromosome but not its localization .other studies sheds light on a possible mechanism of breast carcinogenesis mediated by XIST misbehaviour .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cases			Genetic: XIST gene deletion
control			Genetic: XIST gene deletion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XIST gene deletion	Genetic	detection of XIST gene deletion by fluorescence in situ hybridization	cases control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eman Mosaad Zaki, PhD	Contact	00201065518821		Eman_mosaad@hotmail.com
Engy Adel Shafik, PhD	Contact	00201223809172		engyadelshafik@yahoo.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30975222	Background	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.
28969709	Background

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases