Expressiona and Diagnostic Potential of miRNAs in NSCLC | NCT05815407

Studies
Expressiona and Diagnostic Potential of miRNAs in NSCLC

NCT05815407

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

Apr 18, 2023Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Non Small Cell Lung Cancer

Interventions

No intervention

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

Apr 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

Sep 1, 2018Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Apr 4, 2023

First Submission Date that Met QC Criteria

Apr 4, 2023

First Posted Date

Apr 18, 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

Apr 4, 2023

Last Update Posted Date

Apr 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Elshafei, Professor Associate of Medical Biochemistry and Molecular Biology, Al-Azhar UniversityPrincipal Investigator

Lead Sponsor

Al-Azhar UniversityOTHER

Collaborators

Name	Class
National Cancer Institute, Cairo University, Egypt	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Its to explore the expression pattern, diagnostic and prognostic potentials of miRs (106b-5p, 601 and 760) in serum of NSCLC patients

Detailed Description

A retrospective observational study on NSCLC patients, to determine the serum expression levels if some miRNAs in NSCLC patients and to find if having proper diagnostic and prognostic values in early disease detection, and/or staging.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NSCLC patients		Patients were diagnosed with NSCLC at any stage, then will be subdivided into Early stage, Lympho-node involvement stage and Distant metastatic stage	Other: No intervention
Control subjects		Appearantly healthy age-matched individuals	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Control subjects NSCLC patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of the expression	Expression profiling of the selected miRNAs	By the end of the study (September 2022)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

First time and recently diagnosed NSCLC patient

Exclusion Criteria:

Recurrent NSCLC
Start of chemotherapy, radiotherapy or surgical intervention
Previous treatment
Cancer history

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Case-control

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt		Cairo		11231	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided