Brief Title
Research on Optimization and Evaluation of Oral Cancer Screening Methods
Official Title
Research on Optimization and Evaluation of Oral Cancer Screening Methods
Brief Summary
An evaluation and validation study on oral cancer screening methods will be carried out, and two different methods will be used for oral cancer screening among the population. The two different methods are: (1) clinical observation (including inspection and palpation) combined with pathological biopsy. (2) Clinical observation (including inspection and palpation), in vivo staining (toluidine blue) combined with pathological biopsy. By evaluating and comparing the sensitivity and specificity of the two screening methods, the more effective oral cancer screening method will be selected.
Detailed Description
An evaluation and validation study on oral cancer screening methods will be carried out, and two different methods will be used for oral cancer screening among the population. The two different methods are: (1) clinical observation (including inspection and palpation) combined with pathological biopsy. That is, inspecting and palpating the oral cavity and neck of the screened object. If positive lesions are found, then further pathological biopsy will be performed. This is also the commonly used screening method for oral cancer now; (2) Clinical observation (including inspection and palpation), in vivo staining (toluidine blue) combined with pathological biopsy. That is, toluidine blue staining is performed at the same time as the inspection and palpation of the oral cavity and neck of the screening object. As long as the screening subjects found positive lesions or abnormal living body staining, pathological biopsy was performed. By evaluating and comparing the sensitivity and specificity of the two screening methods, the more effective oral cancer screening method will be selected. Finally, we will carry out prospective controlled population studies in high-risk areas and non-high-risk areas to further evaluate the effectiveness and feasibility of screening method after selection.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
The rate of participants being detected as positive
Condition
Oral Cancer
Intervention
clinical observation combined with pathological biopsy
Study Arms / Comparison Groups
clinical observation combined with pathological biopsy
Description: Clinical observation (including inspection and palpation) combined with pathological biopsy. That is, inspecting and palpating the oral cavity and neck of the screened object. If positive lesions are found, then further pathological biopsy will be performed.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
10000
Start Date
June 2021
Completion Date
December 2023
Primary Completion Date
June 2023
Eligibility Criteria
Inclusion Criteria: - aged 40-69 years old. Exclusion Criteria: - No.
Gender
All
Ages
40 Years - 69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, ,
Administrative Informations
NCT ID
NCT04919460
Organization ID
CN-oral
Responsible Party
Sponsor
Study Sponsor
Hunan Cancer Hospital
Study Sponsor
, ,
Verification Date
June 2021