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Research on Optimization and Evaluation of Oral Cancer Screening Methods

NCT04919460 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2021-06-09

No results posted yet for this study

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.

Conditions

  • Oral Cancer

Interventions

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.

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.

Sponsors & Collaborators

  • Hunan Cancer Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2023-06-30
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04919460 on ClinicalTrials.gov