Oral CancerEarly Phase 1NCT04919460
Research on Optimization and Evaluation of Oral Cancer Screening Methods
A Early Phase 1 study testing clinical observation combined with pathological biopsy and Clinical observation, in vivo staining (reagent: toluidine blue) combined with pathological biopsy in people with Oral Cancer, run by Hunan Cancer Hospital.
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. Read more about this study
- Who is it for?
- Ages 40 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer
- What is being tested?
- clinical observation combined with pathological biopsy and Clinical observation, in vivo staining (reagent: toluidine blue) combined with pathological biopsy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Dec 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 40-69 years old.
Who cannot join
- No.
About this study
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.
Read the 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.
- Conditions
- Oral Cancer
- Being tested
- clinical observation combined with pathological biopsy, Clinical observation, in vivo staining (reagent: toluidine blue) combined with pathological biopsy
- Keywords
- Oral cancer, Screening Method
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical observation combined with pathological biopsyOther
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 biopsyOther
(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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Clinical observation, in vivo staining (reagent: toluidine blue) combined with pathological biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of participants being detected as positive
Among all participants, the rate of being tested positive by two methods
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919460
- Sponsor's protocol ID
- CN-oral
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Optimization and Evaluation of Oral Cancer Screening Methods
- ClinicalTrials.gov ID
- NCT04919460
- Acronym / sponsor ID
- CN-oral
- Conditions
- Oral Cancer
- Keywords
- Oral cancer, Screening Method
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clinical observation combined with pathological biopsy | Other | Other: clinical observation combined with pathological biopsyClinical 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, in vivo staining combined with pathological biopsy | Experimental | Other: Clinical observation, in vivo staining (reagent: toluidine blue) combined with pathological biopsyClinical 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. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 40-69 years old.
Key exclusion criteria (1 listed)
- No.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical observation combined with pathological biopsyInspecting 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 (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. | Other | Clinical observation, in vivo staining combined with pathological biopsy |
Primary outcome
The rate of participants being detected as positive
Time frame: 1 year
Among all participants, the rate of being tested positive by two methods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing clinical observation combined with pathological biopsy and Clinical observation, in vivo staining (reagent: toluidine blue) combined with pathological biopsy in people with Oral Cancer, run by Hunan Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of participants being detected as positive (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.