Research on Optimization and Evaluation of Oral Cancer Screening Methods

NCT04919460 | Unknown Early Phase 1

• 1 other identifier: CN-oral
• Study Type: interventional
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Cancer

Keywords

Oral cancer; Screening Method

Outcome Measures

Primary Outcomes (1)

• The rate of participants being detected as positive

  Among all participants, the rate of being tested positive by two methods

  1 year

Study Arms (2)

clinical observation combined with pathological biopsy

OTHER

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.

Other: clinical observation combined with pathological biopsy

Clinical observation, in vivo staining combined with pathological biopsy

EXPERIMENTAL

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.

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

Interventions

clinical observation combined with pathological biopsy 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 combined with pathological biopsy

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

Clinical observation, in vivo staining combined with pathological biopsy

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 40-69 years old.

You may not qualify if:

• No.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 9, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 9, 2021

Record last verified: 2021-06