Oral CancerPhase 3NCT00655421
Oral Cancer Screening in Mumbai, India by Primary Health Care Workers
A Phase 3 study testing Unaided Visual Inspection, VelScope and Toluidine Blue Assisted Oral Examination in people with Oral Cancer and Precancerous Conditions, run by Tata Memorial Hospital at 1 site in India.
Trial summary
A feasibility study to compare the test characteristics of three different oral cancer screening techniques performed by trained primary health care workers:1)Unaided Visual Inspection, 2)VelScope Assisted Examination, and 3) Examination after application of Toluidine Blue dye. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Precancerous Conditions
- What is being tested?
- Unaided Visual Inspection, VelScope and Toluidine Blue Assisted Oral Examination
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2008to Sep 2009
- Phase
- Phase 3
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study participants will be apparently healthy males with tobacco habit ( present tobacco users and those who have quit within past six months),
- above 18 years of age,
- attending Preventive Oncology clinic.
Who cannot join
- Participants with frank oral cancers will not be recruited in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Test Characteristics of Three Oral Cancer Screening Techniques:1)Unaided Visual Examination 2)VelScope Examination and 3)Toluidine Blue Application, by Trained Primary Health Care Workers in Mumbai, India.
A feasibility study to compare the test characteristics of three different oral cancer screening techniques performed by trained primary health care workers:1)Unaided Visual Inspection, 2)VelScope Assisted Examination, and 3) Examination after application of Toluidine Blue dye.
Read the detailed description
Oral cancer is the most common cancer among men in India mainly due to the habit of using smokeless tobacco. Pre-cancerous lesions like leukoplakia, melanoplakia, erythroplakia,oral submucous fibrosis and indolent ulcers can be easily detected by periodic examination of the oral cavity of the at-risk populations. Several methods of oral cancer screening have been tried over the past three-four decades with varying success. This study investigates the feasibility of application and compares the test characteristics of three oral cancer screening techniques: Unaided Visual Inspection, VelScope assisted examination and examination after application of Toluidine blue dye by primary health care workers among tobacco users attending a cancer early detection clinic, in Mumbai, India.
- Conditions
- Oral Cancer, Precancerous Conditions
- Being tested
- Unaided Visual Inspection, VelScope, Toluidine Blue Assisted Oral Examination
- Keywords
- screening, oral precancers, tobacco users, VELScope, Visual Inspection, Toluidine Blue
- Medical subject headings
- Mouth Neoplasms, Precancerous Conditions, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unaided Visual InspectionOther
Simple unaided visual inspection of the oral cavity with a bright white light source by trained Primary Health Care Worker
VelScopeDevice
Examination of the oral cavity through a VelScope by trained Primary Health Care Worker
Toluidine Blue Assisted Oral ExaminationOther
Examination of the oral cavity after the local application of Toluidine Blue dye by trained Primary Health Care Worker
| Study group | Role | What they receive |
|---|---|---|
| Unaided | Experimental | Unaided Visual Inspection of the Oral Cavity Receives: Other: Unaided Visual Inspection |
| VelScope | Experimental | VelScope assisted examination of the oral cavity Receives: Device: VelScope |
| Toluidine | Experimental | Examination of oral cavity after the local application of Toluidine Blue dye Receives: Other: Toluidine Blue Assisted Oral Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility and efficacy of performance of the three oral cancer screening tests viz. naked eye unaided examination , examination using VELScope and after application of Toluidine Blue by trained primary health workers.
Measured: six months
Secondary outcomes (1)
To estimate the test characteristics of each of the three oral cancer screening techniques.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (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
- Phase 3
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Collaborators
- American Cancer Society, Inc., Emory University
- Investigators
- Surendra S Shastri, MD, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655421
- Sponsor's protocol ID
- 391
- Status last verified
- Jul 2009
- First submitted
- 3 Apr 2008
- Last updated
- 3 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Test Characteristics of Three Oral Cancer Screening Techniques:1)Unaided Visual Examination 2)VelScope Examination and 3)Toluidine Blue Application, by Trained Primary Health Care Workers in Mumbai, India.
- ClinicalTrials.gov ID
- NCT00655421
- Acronym / sponsor ID
- 391
- Conditions
- Oral Cancer, Precancerous Conditions
- Keywords
- screening, oral precancers, tobacco users, VELScope, Visual Inspection, Toluidine Blue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Collaborators
- American Cancer Society, Inc., Emory University
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 9 Apr 2008 (estimated)
- 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.
A feasibility study to compare the test characteristics of three different oral cancer screening techniques performed by trained primary health care workers:1)Unaided Visual Inspection, 2)VelScope Assisted Examination, and 3) Examination after application of Toluidine Blue dye.
Detailed description
Oral cancer is the most common cancer among men in India mainly due to the habit of using smokeless tobacco. Pre-cancerous lesions like leukoplakia, melanoplakia, erythroplakia,oral submucous fibrosis and indolent ulcers can be easily detected by periodic examination of the oral cavity of the at-risk populations. Several methods of oral cancer screening have been tried over the past three-four decades with varying success. This study investigates the feasibility of application and compares the test characteristics of three oral cancer screening techniques: Unaided Visual Inspection, VelScope assisted examination and examination after application of Toluidine blue dye by primary health care workers among tobacco users attending a cancer early detection clinic, in Mumbai, India.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unaided | Experimental | Other: Unaided Visual InspectionUnaided Visual Inspection of the Oral Cavity |
| VelScope | Experimental | Device: VelScopeVelScope assisted examination of the oral cavity |
| Toluidine | Experimental | Other: Toluidine Blue Assisted Oral ExaminationExamination of oral cavity after the local application of Toluidine Blue dye |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The study participants will be apparently healthy males with tobacco habit ( present tobacco users and those who have quit within past six months),
- above 18 years of age,
- attending Preventive Oncology clinic.
Key exclusion criteria (1 listed)
- Participants with frank oral cancers will not be recruited in the study.
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 |
|---|---|---|
| Unaided Visual InspectionSimple unaided visual inspection of the oral cavity with a bright white light source by trained Primary Health Care Worker | Other | Unaided |
| VelScopeExamination of the oral cavity through a VelScope by trained Primary Health Care Worker | Device | VelScope |
| Toluidine Blue Assisted Oral ExaminationExamination of the oral cavity after the local application of Toluidine Blue dye by trained Primary Health Care Worker | Other | Toluidine |
Primary outcome
To evaluate the feasibility and efficacy of performance of the three oral cancer screening tests viz. naked eye unaided examination , examination using VELScope and after application of Toluidine Blue by trained primary health workers.
Time frame: six months
1 secondary outcome
To estimate the test characteristics of each of the three oral cancer screening techniques.
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2009.
- Customized optical device helps dentists to detect oral cancerLink provided by the sponsor.
Related trials for Oral Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
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.
Surendra S Shastri, MD principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Unaided Visual Inspection, VelScope and Toluidine Blue Assisted Oral Examination in people with Oral Cancer and Precancerous Conditions, run by Tata Memorial Hospital at 1 site in India.
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 3 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 3 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To evaluate the feasibility and efficacy of performance of the three oral cancer screening tests viz. naked eye unaided examination , examination using VELScope and after application of Toluidine Blue by trained primary health workers. (time frame: six months). 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 3 Jul 2009.