Clinical trial · Interventional
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
NCT03345966CI-TRIAL-00030411unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bmi-1 antibody | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immunohistochemistry
- description
- 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.
- interventionNames
- Diagnostic Test: Bmi-1 antibody
- type
- EXPERIMENTAL
- label
- Polymerase Chain Reaction PCR
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- RESULTDalley 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 24415717