Moderate Epithelial DysplasiaNCT01695018
Early Diagnosis of Oral Cancer by Detecting p16 Methylation
An observational study of Moderate Epithelial Dysplasia and Mild Epithelial Dysplasia, run by Peking University.
Trial summary
The purpose of this study is to verify the function of p16 methylation diagnostic reagents in early diagnosis of oral cancer. Read more about this study
- Who is it for?
- Ages 25 to 78 years
- Conditions the study is for
- Moderate Epithelial Dysplasia, Mild Epithelial Dysplasia
- Type of treatment
- Pill or oral medicine
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Mar 2014
- Phase
- Observational
- 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 25 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 180 patients with mild or moderate oral epithelial dysplasia were selected. 81 of them were from Peking University of Stomatology and 68 were from Capital Medical University School of Stomatology and other 31 were from Fourth Military Medical University School of Stomatology.All of the patients with OED had been diagnosed pathologically by at least two senior pathologists using the criteria from '2005 WHO Classification System' and The oral tissue pathology diagnostic criteria (oral histopathology Edition Sixth).All cases involved primary lesions without any LASER, radiation therapy or chemotherapy.
Who may be able to join
- Histopathological diagnosis of oral lesions meet the epithelial diagnostic criteria for mild to moderate grade OED
- No local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips
- Without the OCE treatment history by laser , radiation or chemical
- Be able to Sign the informed consent
Who cannot join
- Histopathological diagnosis of oral lesions do not meet the epithelium of mild to moderate dysplasia diagnostic criteria; histological diagnosis of severe grade OED or malignant disease
- Pregnancy or breast-feeding women
- Serious heart, lung, liver , kidney and other systemic diseases
- local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips
- OED treatment history by LASER, radiotherapy, or chemotherapy
- Tumor and psychiatric patients
- Patients are unable to cooperate
About this study
Official title: A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Methylation
The purpose of this study is to verify the function of p16 methylation diagnostic reagents in early diagnosis of oral cancer.
Read the detailed description
Background:Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese adults. To investigate the clinical predictive value of p16 methylation diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the prospective multi-center double-blind cohort study.
Methods:180 patients with histologically confirmed mild or moderate OED were included in the present study. The investigators using p16 methylation diagnostic reagents to analysis of the p16 methylation status in these patients. Building two follow-up queue by p16-methylated and p16-unmethylated. The Statistical analysis used SAS6.12 software. All P-values were two-sided. P<0.05 was considered to test for statistical significance difference.
- Keywords
- oral epithelial dysplasia, p16 methylation, diagnostic reagents, early diagnosis
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| p16 methylation positive | 48 patients with mild or moderate oral epithelial dysplasia containing methylated p16. | |
| p16 methylation negative | 104 patients with p16 mild or moderate oral epithelial dysplasia NOT containing methylated p16. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 methylation
152 participants were p16 methylated informative. 29 participants were NOT informative because enough DNA was not extracted from their paraffin slides.
Among these informative cases, oral specimens from 48 patients were p16 methylation positive and 104 patients were p16 methylation negative. The cancer rate in the p16 methylation positive patients during the followup period will be compared with that in the p16 methylation negative patients statistically.
Measured: frome 3 months to 63 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startFeb 2009
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Epithelial DysplasiaStudies of the same condition, open and under way.
- More trials run by Peking 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Liu, MD, PhD, Peking University
- Investigators
- Dajun Deng, MD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695018
- Sponsor's protocol ID
- PKUSSOM20120711
- Status last verified
- Sep 2014
- First submitted
- 25 Sep 2012
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Methylation
- ClinicalTrials.gov ID
- NCT01695018
- Acronym / sponsor ID
- PKUSSOM20120711
- Keywords
- oral epithelial dysplasia, p16 methylation, diagnostic reagents, early diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2014 (actual)
- First posted
- 27 Sep 2012 (estimated)
- 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 purpose of this study is to verify the function of p16 methylation diagnostic reagents in early diagnosis of oral cancer.
Detailed description
Background:Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese adults. To investigate the clinical predictive value of p16 methylation diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the prospective multi-center double-blind cohort study.
Methods:180 patients with histologically confirmed mild or moderate OED were included in the present study. The investigators using p16 methylation diagnostic reagents to analysis of the p16 methylation status in these patients. Building two follow-up queue by p16-methylated and p16-unmethylated. The Statistical analysis used SAS6.12 software. All P-values were two-sided. P<0.05 was considered to test for statistical significance difference.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| p16 methylation positive | – | –48 patients with mild or moderate oral epithelial dysplasia containing methylated p16. |
| p16 methylation negative | – | –104 patients with p16 mild or moderate oral epithelial dysplasia NOT containing methylated p16. |
Who may qualify
- Ages
- 25 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 180 patients with mild or moderate oral epithelial dysplasia were selected. 81 of them were from Peking University of Stomatology and 68 were from Capital Medical University School of Stomatology and other 31 were from Fourth Military Medical University School of Stomatology.All of the patients with OED had been diagnosed pathologically by at least two senior pathologists using the criteria from '2005 WHO Classification System' and The oral tissue pathology diagnostic criteria (oral histopathology Edition Sixth).All cases involved primary lesions without any LASER, radiation therapy or chemotherapy.
Key inclusion criteria (4 listed)
- Histopathological diagnosis of oral lesions meet the epithelial diagnostic criteria for mild to moderate grade OED
- No local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips
- Without the OCE treatment history by laser , radiation or chemical
- Be able to Sign the informed consent
Key exclusion criteria (7 listed)
- Histopathological diagnosis of oral lesions do not meet the epithelium of mild to moderate dysplasia diagnostic criteria; histological diagnosis of severe grade OED or malignant disease
- Pregnancy or breast-feeding women
- Serious heart, lung, liver , kidney and other systemic diseases
- local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips
- OED treatment history by LASER, radiotherapy, or chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 methylation
Time frame: frome 3 months to 63 months
152 participants were p16 methylated informative. 29 participants were NOT informative because enough DNA was not extracted from their paraffin slides. Among these informative cases, oral specimens from 48 patients were p16 methylation positive and 104 patients were p16 methylation negative. The cancer rate in the p16 methylation positive patients during the followup period will be compared with that in the p16 methylation negative patients statistically.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Peking UniversityLink provided by the sponsor.
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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.
Dajun Deng, MD principal investigator
Peking University
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate Epithelial Dysplasia and Mild Epithelial Dysplasia, run by Peking University.
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 7 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: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 methylation (time frame: frome 3 months to 63 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2014.