Therapeutic Effect Of Luteolin Natural Extract Versus Its... | NCT03288298

Studies
Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line

NCT03288298

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Sep 20, 2017Actual

Enrollment

4Estimated

Phase

Early Phase 1

Conditions

Tongue Neoplasms
Carcinoma

Interventions

luteolin
nano-luteolin

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

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, 2017Estimated

Primary Completion Date

Sep 1, 2018Estimated

Completion Date

Apr 1, 2019Estimated

First Submitted Date

Sep 12, 2017

First Submission Date that Met QC Criteria

Sep 18, 2017

First Posted Date

Sep 20, 2017Actual

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 18, 2017

Last Update Posted Date

Sep 20, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Safaa Elbaz, Assistant Lecturer, Oral and Maxillofacial Pathology, BUE, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

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

In vitro study to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line.

Detailed Description

This study is conducted to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line. The primary outcome is apoptosis, while the secondary outcome is cell viability.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
luteolin	Experimental	a natural extract derived flavinoids	Drug: luteolin
nano-luteolin	Active Comparator	nano-particles derived from a natural extract luteolin	Drug: nano-luteolin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
luteolin	Drug	flavonoid natural extract	luteolin	3',4',5,7-tetrahydroxyflavone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
gene expression of Caspase 3 to detect apoptosis	fold-changes	6 hours

Secondary Outcomes

Measure	Description	Time Frame
cell viability	micromolar	6 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Squamous cell carcinoma cell lines (OSCC, TSCC and HNSCC).
Luteolin 5,7,3',4'-tetrahydroxy-flavone (MeSH term).
Application of luteolin as a chemotherapeutic drug.

Exclusion Criteria:

Any cancer cell line other than OSCC, TSCC and HNSCC cell lines.
Luteolin glycosides.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Safaa M. Baz, Masters	Contact	002 01119777824		drsafaaelbaz@gmail.com
Safa F. Abd El-Ghani, PhD	Contact	002 01005198010		drsafa.fathy@yahoo.com

Overall Officials

Name	Affiliation	Role
Ahmed Elkhadem, PhD	Center for Evidence Based Dentistry	Study Chair

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24287949	Background	Ding S, Hu A, Hu Y, Ma J, Weng P, Dai J. Anti-hepatoma cells function of luteolin through inducing apoptosis and cell cycle arrest. Tumour Biol. 2014 Apr;35(4):3053-60. doi: 10.1007/s13277-013-1396-5. Epub 2013 Nov 28.

ID	Term
D014062	Tongue Neoplasms
D002277	Carcinoma
D009062	Mouth Neoplasms

ID	Term
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009059	Mouth Diseases

ID	Term
D047309	Flavones
D005419	Flavonoids
D002867	Chromones
D001578	Benzopyrans
D011714