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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03345966
Enrollment
18
Registered
2017-11-17
Start date
2017-12-01
Completion date
2019-11-30
Last updated
2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Squamous Cell Carcinoma

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTBmi-1 antibody

B-lymphoma Moloney murine leukemia virus insertion region-1

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Bmi-1 antibody using immunohistochemistry and PCR

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
oral squamous cell carcinoma10 monthsDifferent grades of oral squamous cell carcinoma

Countries

Egypt

Contacts

Primary ContactAsmaa M. Abou Gabal, Master
asmaaabougabal@hotmail.com01016654242
Backup ContactAsmaa M. Abou Gabal, Master
ahdytayel82@gmail.com01223460340

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026