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Research on Optimization and Evaluation of Oral Cancer Screening Methods

Primary Purpose

Oral Cancer

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
clinical observation combined with pathological biopsy
Clinical observation, in vivo staining (reagent: toluidine blue) combined with pathological biopsy
Sponsored by
Hunan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Oral Cancer focused on measuring Oral cancer, Screening Method

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • aged 40-69 years old.

Exclusion Criteria:

  • No.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    clinical observation combined with pathological biopsy

    Clinical observation, in vivo staining combined with pathological biopsy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 27, 2021
    Last Updated
    June 2, 2021
    Sponsor
    Hunan Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04919460
    Brief Title
    Research on Optimization and Evaluation of Oral Cancer Screening Methods
    Official Title
    Research on Optimization and Evaluation of Oral Cancer Screening Methods
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hunan Cancer Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Cancer
    Keywords
    Oral cancer, Screening Method

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    clinical observation combined with pathological biopsy
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Clinical observation, in vivo staining combined with pathological biopsy
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    clinical observation combined with pathological biopsy
    Intervention Description
    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
    Intervention Name(s)
    Clinical observation, in vivo staining (reagent: toluidine blue) combined with pathological biopsy
    Intervention Description
    (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.
    Primary Outcome Measure Information:
    Title
    The rate of participants being detected as positive
    Description
    Among all participants, the rate of being tested positive by two methods
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: aged 40-69 years old. Exclusion Criteria: No.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Research on Optimization and Evaluation of Oral Cancer Screening Methods

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