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

Oral Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03345966
• Other study ID #: CEBD-CU-2017-11-01
• Status: Not yet recruiting
• Phase: N/A
• First received: November 10, 2017
• Last updated: November 14, 2017
• Start date: December 1, 2017
• Est. completion date: November 2019

Study information

• Verified date: November 2017
• Source: Cairo University
• Contact: Asmaa M. Abou Gabal, Master
• Phone: 01016654242
• Email: asmaaabougabal[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: November 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oral Squamous Cell Carcinoma

Intervention

Diagnostic Test:
• Bmi-1 antibody
B-lymphoma Moloney murine leukemia virus insertion region-1

Locations

Country	Name	City	State
Egypt	Asmaa M. Abou Gabal	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral squamous cell carcinoma	Different grades of oral squamous cell carcinoma	10 months