Research on Optimization and Evaluation of Oral Cancer Screening Methods
June 2, 2021 updated by: Hunan Cancer Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Interventional
Enrollment (Anticipated)
10000
Phase
- Early Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 40-69 years old.
Exclusion Criteria:
- No.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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.
|
Inspecting and palpating the oral cavity and neck of the screened object.
If positive lesions are found, then further pathological biopsy will be performed.
|
|
Experimental: 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.
|
(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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The rate of participants being detected as positive
Time Frame: 1 year
|
Among all participants, the rate of being tested positive by two methods
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2021
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
May 27, 2021
First Submitted That Met QC Criteria
June 2, 2021
First Posted (Actual)
June 9, 2021
Study Record Updates
Last Update Posted (Actual)
June 9, 2021
Last Update Submitted That Met QC Criteria
June 2, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CN-oral
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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