Oral Squamous Cell CarcinomaNCT03345966
Assessment of Bmi-1 on Protein and Molecular Levels in Oral Dysplasia and Squamous Cell Carcinoma: A Diagnostic Study
A study testing Bmi-1 antibody in people with Oral Squamous Cell Carcinoma, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Squamous Cell Carcinoma
- What is being tested?
- Bmi-1 antibody
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Assessment of Bmi-1 on Protein and Molecular Levels in Oral Dysplasia and Squamous Cell Carcinoma: A Diagnostic Study
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.
Read the 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.
- Conditions
- Oral Squamous Cell Carcinoma
- Being tested
- Bmi-1 antibody
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bmi-1 antibodyDiagnostic test
Also called Expression of Bmi-1 molecule at RNA level by PCR and protein level by immunohistochemistry in oral dysplasia and squamous cell carcinoma
B-lymphoma Moloney murine leukemia virus insertion region-1
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Diagnostic Test: Bmi-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral squamous cell carcinoma
Different grades of oral squamous cell carcinoma
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Dec 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Bmi-1 antibody using immunohistochemistry and PCR
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohamed Abo Gabal, Cairo University
- Investigators
- Iman A. Radi, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345966
- Sponsor's protocol ID
- CEBD-CU-2017-11-01
- Status last verified
- Nov 2017
- First submitted
- 10 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24415717
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Assessment of Bmi-1 on Protein and Molecular Levels in Oral Dysplasia and Squamous Cell Carcinoma: A Diagnostic Study
- ClinicalTrials.gov ID
- NCT03345966
- Acronym / sponsor ID
- CEBD-CU-2017-11-01
- Conditions
- Oral Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Bmi-1 antibody using immunohistochemistry and PCR
| Arm | Type | Receives |
|---|---|---|
| Immunohistochemistry | Experimental | Diagnostic Test: Bmi-1 antibodyIn 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. |
| Polymerase Chain Reaction PCR | Experimental | Diagnostic Test: Bmi-1 antibodyCalculation 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bmi-1 antibodyAlso: Expression of Bmi-1 molecule at RNA level by PCR and protein level by immunohistochemistry in oral dysplasia and squamous cell carcinomaB-lymphoma Moloney murine leukemia virus insertion region-1 | Diagnostic test | Immunohistochemistry, Polymerase Chain Reaction PCR |
Primary outcome
oral squamous cell carcinoma
Time frame: 10 months
Different grades of oral squamous cell carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Results publication: PubMed 24415717Dalley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iman A. Radi, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bmi-1 antibody in people with Oral Squamous Cell Carcinoma, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa M. Abou Gabal, Master (01016654242, asmaaabougabal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral squamous cell carcinoma (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03345966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.