Trial Outcomes & Findings for Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia (NCT NCT00835341)

Results Overview

The follow-up examination was carried out with a 3-month interval. Re-biopsy was done as clinically indicated, e.g. the lesion recurs or has tendency for malignant development. Pathologic diagnosis was made by at least two pathologists without the knowledge of baseline p16 methylation, based on the World Health Organization's criteria, at Peking University School of Stomatology. The number of participants with malignant transformation of oral dysplasia was calculated based on the number of participants with oral dysplasia progressed to carcinoma by the end of the trial in each cohorts.

Recruitment status

COMPLETED

Target enrollment

93 participants

Primary outcome timeframe

from 3 months to 124 months

Results posted on

2015-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	p16-methylated patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.	p16-unmethylated patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
Overall Study STARTED	35	58
Overall Study COMPLETED	32	46
Overall Study NOT COMPLETED	3	12

Reasons for withdrawal

Reasons for withdrawal
Measure	p16-methylated patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.	p16-unmethylated patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
Overall Study Lost to Follow-up	3	12

Baseline Characteristics

Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	p16-methylated n=35 Participants patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.	p16-unmethylated n=58 Participants patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.	Total n=93 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	39 Participants n=7 Participants	62 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	19 Participants n=7 Participants	31 Participants n=5 Participants
Age, Continuous	57.5 years STANDARD_DEVIATION 12.0 • n=5 Participants	57.9 years STANDARD_DEVIATION 11.0 • n=7 Participants	57.7 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	36 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	22 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment China	35 participants n=5 Participants	58 participants n=7 Participants	93 participants n=5 Participants

PRIMARY outcome

Timeframe: from 3 months to 124 months

The follow-up examination was carried out with a 3-month interval. Re-biopsy was done as clinically indicated, e.g. the lesion recurs or has tendency for malignant development. Pathologic diagnosis was made by at least two pathologists without the knowledge of baseline p16 methylation, based on the World Health Organization's criteria, at Peking University School of Stomatology. The number of participants with malignant transformation of oral dysplasia was calculated based on the number of participants with oral dysplasia progressed to carcinoma by the end of the trial in each cohorts.

Outcome measures

Outcome measures
Measure	p16-methylated n=35 Participants patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.	p16-unmethylated n=58 Participants patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia	32 participants	46 participants

SECONDARY outcome

Timeframe: from 3 months to 124 months

Outcome measures

Outcome data not reported

Adverse Events

p16-methylated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

p16-unmethylated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Department of Etiology

Peking University School of Oncology

Phone: +8610-88196752

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place