Immunohistochemistry Role in Better Prognosis of Endometr... | NCT06148129

Studies
Immunohistochemistry Role in Better Prognosis of Endometrial Carcinoma Patients

NCT06148129

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Nov 28, 2023Actual

Enrollment

96Actual

Phase

Not Applicable

Conditions

Endometrial Cancer

Interventions

Tissue Biopsy

Countries

Egypt

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2019Actual

Primary Completion Date

Oct 1, 2021Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Nov 13, 2023

First Submission Date that Met QC Criteria

Nov 27, 2023

First Posted Date

Nov 28, 2023Actual

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

Nov 27, 2023

Last Update Posted Date

Nov 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Walid Mohamed Elnagar, Assistant professor of gynecology, Zagazig UniversityPrincipal Investigator

Lead Sponsor

Zagazig UniversityOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 incidence of endometrial cancer (EC) is increasing .Different risk classifications are used to direct the primary and adjuvant therapy. The European Society for Medical Oncology - European Society of Gynaecological Oncology -European Society for Radiotherapy & Oncology (ESMO-ESGO- ESTRO) could guide the need for lymph node surgery pre-operatively, and also post-operatively to determine adjuvant treatment.

Low-risk patients are managed with surgery alone, while higher-risk group patients undergo more aggressive surgical options. So, it is important to identify new prognostic markers for better stratification of patients to avoid under- or over treatment of EC patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Active Comparator		Diagnostic Test: Tissue Biopsy
Excluded Patients	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tissue Biopsy	Diagnostic Test	The Post-hysterectomy tissue biopsy was analyzed immunohistochemically for detection of estrogen and progesterone receptors, P53 and L1CAM	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
expression levels of p53/L1CAM/ER/PR	The Prognostic value of immunohistochemical detection of expression levels of p53/L1CAM/ER/PR in relation to ESMO-ESGO-ESTRO risk groups	36 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 36 -72 years;
Previously diagnosed with endometrial carcinoma;
Histological Type of the tumor;
Myometrial Invasion;
lymph Node Invasion;
Cervical Invasion;
Biomarkers expression.

Exclusion Criteria:

Lack of tumor tissue in tissue block

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

36 Years

Maximum Age

72 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zagazig university		Zagazig	Ash Sharqia Governorate	44519	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D016889	Endometrial Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided