Know Cancer

or
forgot password

A Cohort Study on Prediction of Malignant Transformation of Oral Epithelial Dysplasia by p16 Methylation


N/A
N/A
N/A
Not Enrolling
Both
Oral Epithelial Dysplasia, Mild or Moderate Grade

Thank you

Trial Information

A Cohort Study on Prediction of Malignant Transformation of Oral Epithelial Dysplasia by p16 Methylation


- Background: Identification of malignant potential of oral epithelial dysplasia (OED) is
virtually impossible on histopathological grounds alone. Inactivation of p16 gene by
CpG methylation is an early frequent event during oral carcinogenesis. To investigate
the predictive value of p16 methylation on malignant potential in OED, we carried out
the prospective cohort study.

- Methods: 101 patients with histologically confirmed mild or moderate OED were included
in the present study. Baseline information of p16 methylation status of the OED lesions
from 93 cases was obtained by methylation-specific PCR. Progression of the OEDs lesions
was examined in 78 cases histologically during the 45.8 months double-blind followup
survey (78/93). The association between p16 methylation and progression of OED was
analyzed with SPSS13.0 software. All P-values were two-sided.


Inclusion Criteria:



- histological diagnosis of mild or moderate grade OED; and

- enough amount of tissue sample from OED lesion for genomic DNA extraction; and

- available of methylation status of p16 CpG island in the extracted DNA sample.

Exclusion Criteria:

- histological diagnosis of severe grade OED or malignant disease; or

- amount of tissue sample is not enough for preparation of genomic DNA (20ng); or

- quality of the prepared DNA is not good enough for detection of p16 methylation; or

- OED treatment history by LASER, radiotherapy, or chemotherapy

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia

Outcome Time Frame:

from 3 months to 124 months

Safety Issue:

No

Principal Investigator

Dajun Deng, MD

Investigator Role:

Study Director

Investigator Affiliation:

Beijing Cancer Hospital/ Institue, Peking University School of Oncology

Authority:

China: Ethics Committee

Study ID:

CPDHS-434

NCT ID:

NCT00835341

Start Date:

March 2005

Completion Date:

October 2008

Related Keywords:

  • Oral Epithelial Dysplasia, Mild or Moderate Grade
  • oral epithelial dysplasia
  • p16 methylation
  • prognosis
  • malignant transformation
  • oral squamous cell carcinoma
  • Hyperplasia
  • Carcinoma in Situ

Name

Location