Research on Optimization and Evaluation of Oral Cancer Screening Methods

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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