Role of Fibirnogen Like Protein 2 as Aprognostic Factor i... | NCT04113278

Studies
Role of Fibirnogen Like Protein 2 as Aprognostic Factor in High Grade Glioma

NCT04113278

Sponsor

sohaila Essam

Status

Unknown status

Last Update Posted

Oct 2, 2019Actual

Enrollment

1Estimated

Phase

Not provided

Conditions

Brain Tumor Adult

Interventions

FGL2 immunohisyochemistry

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

Oct 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

Nov 1, 2019Estimated

Primary Completion Date

Sep 1, 2020Estimated

Completion Date

Sep 1, 2021Estimated

First Submitted Date

Oct 1, 2019

First Submission Date that Met QC Criteria

Oct 1, 2019

First Posted Date

Oct 2, 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

Oct 1, 2019

Last Update Posted Date

Oct 2, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

sohaila Essam, Role of fibrinogen like protein 2 as aprognostic factor in high grade glioma, Assiut UniversitySponsor-Investigator

Lead Sponsor

sohaila EssamOTHER

Collaborators

Not provided

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

The study population was selected from high grade glioma pateints attending the Department of Clinical Oncology, Assiut University hospital during the period from December 2018 to September 2020, we analyzed human high grade gliomas paraffin block for FLG2 expression

Detailed Description

Glioblastoma is the most common malignant primary brain tumor in adults, and despite aggressive treatment, it is incurable Patient prognosis differs considerably within the different World Health Organization (WHO) grades, poorest prognosis for patients with the grade IV tumour- the glioblastoma multiform (GBM).

Fibrinogen-like protein 2 (FGL2),regulates both innate and adaptive immunity. FGL2 is a 439 amino acid secreted protein that is similar to the β- and γ-chains of fibrinogen.

Secreted FGL2 (sFGL2) is the key regulator in immunosuppression may play important role in malignant transformation of low to high by inhibiting the proliferation of T cell Study the role of fibrinogen-like protein2 on Immunosuppression and progression ，free survival and overall survival in high grade glioma

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

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FGL2 immunohisyochemistry	Genetic	Correlation between FLG2 expression and progression free survival and overall surviv

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rple of FGL2in high grade glioma as aprognostic factor	Correlation between FLG2 expression and progression free survival and overall survival	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pateints>18 years old
Pathologically proven high grade glioma
Total or subtotal resection of the tumor
Patients received concurrent radiation therapy with temozolomide followed by adjuvant temozolamide for 6 months

Exclusion Criteria:

Pregnancy
Breast feeding
Other comorbidity
Previous malignancy or radiation therapy or chemotherapy

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
samir shehata, professor	Contact	01222302375		Samir-eid@Hotmail.com
mohammed alaa, professor	Contact	01005085973		m.alaa200@hotmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29947810	Background	Latha K, Yan J, Yang Y, Gressot LV, Kong LY, Manyam G, Ezhilarasan R, Wang Q, Sulman EP, Eric Davis R, Huang S, Fuller GN, Rao A, Heimberger AB, Li S, Rao G. The Role of Fibrinogen-Like Protein 2 on Immunosuppression and Malignant Progression in Glioma. J Natl Cancer Inst. 2019 Mar 1;111(3):292-300. doi: 10.1093/jnci/djy107.
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