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Assessment of Bmi-1 on Protein and Molecular Levels in Oral Dysplasia and Squamous Cell Carcinoma: A Diagnostic Study

NCT ID: NCT03345966

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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Head and neck squamous cell carcinoma (HNSCC) including oral squamous cell carcinoma (OSCC) has been reported as the sixth most common cause of cancer mortality in the world and the fifth most commonly occurring cancer. Thus a compelling need for investigation of the underlying molecular events associated with OSCC tumorigenesis has emerged for better understanding of such lesion. Moreover, identification of biomarkers for early detection and prediction of prognosis became of extreme importance, as it was reported that early diagnosis has been vital for effective treatment of OSCC and improved the survival rate of OSCC patients.

OSCC may originate from malignant transformation of the normal oral mucosa, as well as from oral potentially malignant lesions (OPMLs) with different degrees of oral epithelial dysplasia (OED). The approach of a step-wise transition from OPMLs to OSCC was well-established, but it could be difficult to predict if and when an OPML would undergo full transformation and resulted in a tumor. Thus, using specific molecular biomarkers able to identify OED lesions with higher potential for malignant transformation would be very beneficial. Unfortunately, up to date there has been no tools available to monitor OED lesions or HNSCC patients for early stages of local recurrences or distant metastases .

Among the recently introduced biomarkers, B-lymphoma Moloney murine leukemia virus insertion region-1 (BMI1), a member of the polycomb group (PcG) genes, was considered to be pivotal in regulating stemness-related genes involved in maintaining the self-renewal ability of stem cells by promoting chromatin modifications. BMI1 was also known to be deregulated in various human types of cancer. Previous studies have revealed the capability of BMI1 to be used as a prognostic marker in gastric, esophageal, nasopharyngeal cancer, prostate, breast, cervical and ovarian cancer, However, the role of BMI1 in maintaining self-renewal and tumorigenicity in HNSCC or HNSCC-derived cancer stem cells (CSCs) remained to be clarified.

Conditions

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Oral Squamous Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Bmi-1 antibody using immunohistochemistry and PCR
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immunohistochemistry

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.

Group Type EXPERIMENTAL

Bmi-1 antibody

Intervention Type DIAGNOSTIC_TEST

B-lymphoma Moloney murine leukemia virus insertion region-1

Polymerase Chain Reaction PCR

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)

Group Type EXPERIMENTAL

Bmi-1 antibody

Intervention Type DIAGNOSTIC_TEST

B-lymphoma Moloney murine leukemia virus insertion region-1

Interventions

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Bmi-1 antibody

B-lymphoma Moloney murine leukemia virus insertion region-1

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Expression of Bmi-1 molecule at RNA level by PCR and protein level by immunohistochemistry in oral dysplasia and squamous cell carcinoma

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. In vivo studies.
2. Studies using any techniques other than immunohistochemistry or PCR.
3. Samples using any carcinoma rather than squamous cell carcinoma.
4. Samples using benign tumors.
5. Samples using sarcomas.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Mohamed Abo Gabal

teaching assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iman A. Radi, Professor

Role: STUDY_CHAIR

Cairo University

Locations

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Asmaa M. Abou Gabal

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Asmaa M. Abou Gabal, Master

Role: CONTACT

Phone: 01016654242

Email: [email protected]

Asmaa M. Abou Gabal, Master

Role: CONTACT

Phone: 01223460340

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 24415717 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CEBD-CU-2017-11-01

Identifier Type: -

Identifier Source: org_study_id