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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04919460
Other study ID # CN-oral
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date June 2021
Est. completion date December 2023

Study information

Verified date June 2021
Source Hunan Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10000
Est. completion date December 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 69 Years
Eligibility Inclusion Criteria: - aged 40-69 years old. Exclusion Criteria: - No.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hunan Cancer Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of participants being detected as positive Among all participants, the rate of being tested positive by two methods 1 year
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