NCT03345966

Brief Summary

The aim of the current study is to assess the validation of Bmi-1 detection at both protein and molecular levels in oral epithelial dysplasia and oral squamous cell carcinoma as a biomarker for early cancer detection versus biopsy embedded in paraffin blocks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

November 10, 2017

Last Update Submit

November 14, 2017

Conditions

Oral Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • oral squamous cell carcinoma

    Different grades of oral squamous cell carcinoma

    10 months

Study Arms (2)

Immunohistochemistry

EXPERIMENTAL

In order to provide more precised data on Bmi-1 immunoexpression in OSCC, image analyzer will be used. The data will be obtained using the software (SIS, Germany), which comprise a light microscope (Olympus B × 60 Japan) capable of performing high speed digital image processing for the purpose of cell measurements. It will be calibrated automatically to convert the measurement units (pixels) produced by image analyzer program into actual micrometer units.

Diagnostic Test: Bmi-1 antibody

Polymerase Chain Reaction PCR

EXPERIMENTAL

Calculation of Relative Quantification (RQ) (relative expression): After the RT-PCR will run, the data will be expressed in Cycle threshold (Ct).PCR data sheets will include Ct values of assessed gene and the house keeping (reference) gene which will be continuously expressed in the cell- (β-actin).To measure the gene expression of certain gene, -ve control sample shall be used. So target gene expression will be assessed and related to reference (internal control) gene as follows: Finally, RQ was calculated according to the following equation: 1. ∆ Ct (Cycle threshold) = Ct assessed gene - Ct reference gene 2. ∆∆ Ct = ∆ Ct sample - Ct control gene 3. RQ = 2-(∆∆Ct)

Diagnostic Test: Bmi-1 antibody

Interventions

Bmi-1 antibodyDIAGNOSTIC_TEST

B-lymphoma Moloney murine leukemia virus insertion region-1

Also known as: Expression of Bmi-1 molecule at RNA level by PCR and protein level by immunohistochemistry in oral dysplasia and squamous cell carcinoma
ImmunohistochemistryPolymerase Chain Reaction PCR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • In vitro studies.
  • Samples used are oral dysplasia and squamous cell carcinoma.
  • Diagnostic accuracy of Bmi-1 marker on oral dysplasia and SCC.
  • English language published articles only.

You may not qualify if:

  • In vivo studies.
  • Studies using any techniques other than immunohistochemistry or PCR.
  • Samples using any carcinoma rather than squamous cell carcinoma.
  • Samples using benign tumors.
  • Samples using sarcomas.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asmaa M. Abou Gabal

Cairo, Egypt

Location

Related Publications (1)

  • Dalley AJ, Pitty LP, Major AG, Abdulmajeed AA, Farah CS. Expression of ABCG2 and Bmi-1 in oral potentially malignant lesions and oral squamous cell carcinoma. Cancer Med. 2014 Apr;3(2):273-83. doi: 10.1002/cam4.182. Epub 2014 Jan 11.

    PMID: 24415717RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Iman A. Radi, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Asmaa M. Abou Gabal, Master

CONTACT

01016654242asmaaabougabal@hotmail.com

Asmaa M. Abou Gabal, Master

CONTACT

01223460340ahdytayel82@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Bmi-1 antibody using immunohistochemistry and PCR
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teaching assistant

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 17, 2017

Study Start

December 1, 2017

Primary Completion

December 1, 2018

Study Completion

November 1, 2019

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)