Research on Optimization and Evaluation of Oral Cancer Screening Methods

NCT ID: NCT04919460

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2023-12-31

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.

Conditions

Oral Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

clinical observation combined with pathological biopsy

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.

Group Type: OTHER

clinical observation combined with pathological biopsy

Intervention Type: OTHER

Inspecting and palpating the oral cavity and neck of the screened object. If positive lesions are found, then further pathological biopsy will be performed.

Clinical observation, in vivo staining combined with pathological biopsy

Clinical observation (including inspection and palpation), in vivo staining (reagent: toluidine blue) combined with pathological biopsy. That is, inspecting and palpating the oral cavity and neck of the screened object. At the same time, in vivo staining is performed on each participant. The reagent used for staining is toluidine blue. As long as the screening subjects found positive lesions or abnormal living body staining, pathological biopsy was performed.

Group Type: EXPERIMENTAL

Clinical observation, in vivo staining (reagent: toluidine blue) combined with pathological biopsy

Intervention Type: OTHER

(2) Inspecting and palpating the oral cavity and neck of the screened object. At the same time, in vivo staining is performed on each participant. The reagent used for staining is toluidine blue. As long as the screening subjects found positive lesions or abnormal living body staining, pathological biopsy was performed.

Interventions

clinical observation combined with pathological biopsy

Inspecting and palpating the oral cavity and neck of the screened object. If positive lesions are found, then further pathological biopsy will be performed.

Intervention Type: OTHER

Clinical observation, in vivo staining (reagent: toluidine blue) combined with pathological biopsy

(2) Inspecting and palpating the oral cavity and neck of the screened object. At the same time, in vivo staining is performed on each participant. The reagent used for staining is toluidine blue. As long as the screening subjects found positive lesions or abnormal living body staining, pathological biopsy was performed.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• aged 40-69 years old.

Exclusion Criteria

• No.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hunan Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CN-oral

Identifier Type: -

Identifier Source: org_study_id