Oral Epithelial DysplasiaNCT02967120
Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation
An observational study of Oral Epithelial Dysplasia, run by Beijing Municipal Administration of Hospitals at 1 site in China.
Trial summary
The purpose of this study is to verify the function of p16 hydroxymethylation diagnostic reagents in early diagnosis of oral cancer. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Oral Epithelial Dysplasia
- How many people
- 265 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 336 patients with mild or moderate oral epithelial dysplasia were selected. 145 of them are collected from Peking University of Stomatology and 165 were from Capital Medical University School of Stomatology and other 26 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 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hosptial and Institute
Beijing, Beijing Municipality, 100142
Zhaojun Liu, Ph.D, 86-010-88196721, liuzhaojun@bjmu.edu.cn
Dajun Deng, M.D, 86-010-88196752, dengdajun@bjmu.edu.cn
About this study
Official title: A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Hydroxymethylation
The purpose of this study is to verify the function of p16 hydroxymethylation 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 hydroxymethylation diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the prospective multi-center double-blind cohort study.
Methods:265 patients with histologically confirmed mild or moderate OED were included in the present study. After the bisulfite modification and tet assistant bisulfite modification, MethyLight and Methylation-specific PCR (MSP) assays were used to analyze p16 methylation and status in these patients. Building three follow-up queue by p16-methylated, p16-hydroxymethylation and p16-unmethylated. The Statistical analysis used SPSS16.0. All P-values were two-sided. P<0.05 was considered to test for statistical significance difference.
- Conditions
- Oral Epithelial Dysplasia
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| p16 hydroxymethylation status | patients with p16 hydroxymethylation Receives: Other: no intervention |
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 hydroxymethylation
Among these cases, oral specimens from 24 patients were p16-hydroxymethylation, 54 patients were p16-methylation and 187 patients were p16-unmethylation. The cancer rate in the p16-hydroxymethylation patients during the followup period will be compared with that in the other two groups.
Measured: from 3 months to 60 months
Secondary outcomes (1)
Disease free survival of patients with oral epithelial dysplasia containing or Not containing p16 hydroxymethylation
Measured: from 3 months and 36 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 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral Epithelial DysplasiaStudies of the same condition, open and under way.
- 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
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Sponsor type
- Other government
- Collaborators
- Peking University
- Responsible party
- Principal investigator, Zhaojun Liu, Beijing Municipal Administration of Hospitals
- Investigators
- Dajun Deng, MD, Study director, Peking University Cancer Hosptial and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967120
- Sponsor's protocol ID
- XM201303
- Status last verified
- Sep 2017
- First submitted
- 16 Nov 2016
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The number of the participants of different groups and the followup information will be shared with other researchers after the end of the study.
Publications
Liu H, Liu XW, Dong G, Zhou J, Liu Y, Gao Y, Liu XY, Gu L, Sun Z, Deng D. P16 Methylation as an Early Predictor for Cancer Development From Oral Epithelial Dysplasia: A Double-blind Multicentre Prospective Study. EBioMedicine. 2015 Mar 23;2(5):432-7. doi: 10.1016/j.ebiom.2015.03.015. eCollection 2015 May.
PubMed 26137587Cao J, Zhou J, Gao Y, Gu L, Meng H, Liu H, Deng D. Methylation of p16 CpG island associated with malignant progression of oral epithelial dysplasia: a prospective cohort study. Clin Cancer Res. 2009 Aug 15;15(16):5178-83. doi: 10.1158/1078-0432.CCR-09-0580. Epub 2009 Aug 11.
PubMed 19671846Liu H, Liu Z, Liu XW, Xu S, Wang L, Liu Y, Zhou J, Gu L, Gao Y, Liu XY, Shi H, Sun Z, Deng D. A similar effect of P16 hydroxymethylation and true-methylation on the prediction of malignant transformation of oral epithelial dysplasia: observation from a prospective study. BMC Cancer. 2018 Sep 24;18(1):918. doi: 10.1186/s12885-018-4787-6.
PubMed 30249192
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. 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 Hydroxymethylation
- ClinicalTrials.gov ID
- NCT02967120
- Acronym / sponsor ID
- XM201303
- Conditions
- Oral Epithelial Dysplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Beijing Municipal Administration of HospitalsOther government
- Collaborators
- Peking University
- Study start
- Jan 2014
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 17 Nov 2016 (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 hydroxymethylation 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 hydroxymethylation diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the prospective multi-center double-blind cohort study.
Methods:265 patients with histologically confirmed mild or moderate OED were included in the present study. After the bisulfite modification and tet assistant bisulfite modification, MethyLight and Methylation-specific PCR (MSP) assays were used to analyze p16 methylation and status in these patients. Building three follow-up queue by p16-methylated, p16-hydroxymethylation and p16-unmethylated. The Statistical analysis used SPSS16.0. 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
- 1
| Arm | Type | Receives |
|---|---|---|
| p16 hydroxymethylation status | – | Other: no interventionpatients with p16 hydroxymethylation |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 336 patients with mild or moderate oral epithelial dysplasia were selected. 145 of them are collected from Peking University of Stomatology and 165 were from Capital Medical University School of Stomatology and other 26 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 treatment history by laser , radiation or chemical;
- Be able to Sign the informed consent;
Key exclusion criteria (6 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;
- Tumor and psychiatric patients;
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 |
|---|---|---|
| no intervention | Other | p16 hydroxymethylation status |
Primary outcome
Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 hydroxymethylation
Time frame: from 3 months to 60 months
Among these cases, oral specimens from 24 patients were p16-hydroxymethylation, 54 patients were p16-methylation and 187 patients were p16-unmethylation. The cancer rate in the p16-hydroxymethylation patients during the followup period will be compared with that in the other two groups.
1 secondary outcome
Disease free survival of patients with oral epithelial dysplasia containing or Not containing p16 hydroxymethylation
Time frame: from 3 months and 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Background: PubMed 26137587Liu H, Liu XW, Dong G, Zhou J, Liu Y, Gao Y, Liu XY, Gu L, Sun Z, Deng D. P16 Methylation as an Early Predictor for Cancer Development From Oral Epithelial Dysplasia: A Double-blind Multicentre Prospective Study. EBioMedicine. 2015 Mar 23;2(5):432-7. doi: 10.1016/j.ebiom.2015.03.015. eCollection 2015 May.
- Background: PubMed 19671846Cao J, Zhou J, Gao Y, Gu L, Meng H, Liu H, Deng D. Methylation of p16 CpG island associated with malignant progression of oral epithelial dysplasia: a prospective cohort study. Clin Cancer Res. 2009 Aug 15;15(16):5178-83. doi: 10.1158/1078-0432.CCR-09-0580. Epub 2009 Aug 11.
- Derived from this study: PubMed 30249192Liu H, Liu Z, Liu XW, Xu S, Wang L, Liu Y, Zhou J, Gu L, Gao Y, Liu XY, Shi H, Sun Z, Deng D. A similar effect of P16 hydroxymethylation and true-methylation on the prediction of malignant transformation of oral epithelial dysplasia: observation from a prospective study. BMC Cancer. 2018 Sep 24;18(1):918. doi: 10.1186/s12885-018-4787-6.
- Individual participant dataSharing planned: Yes. The number of the participants of different groups and the followup information will be shared with other researchers after the end of the study.
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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 study director
Peking University Cancer Hosptial and Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Epithelial Dysplasia, run by Beijing Municipal Administration of Hospitals at 1 site in China.
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 6 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 25 Sep 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 China. 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 Zhaojun Liu, PhD (86-010-88196721, liuzhaojun@bjmu.edu.cn), or a site near the patient. 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 hydroxymethylation (time frame: from 3 months to 60 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 NCT02967120, which also lists 3 linked publications.
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 2017.