SmokingNCT06535867
The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study
An observational study of Smoking and Smoking, Cigarette, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Mobile health (mHealth) will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers. This program is inclusive of long term surveillance to downstage oral cancer in India Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking, Cigarette, Smoking, Tobacco
- What is being tested?
- mHealth
- Type of treatment
- Pill or oral medicine
- How many people
- 5,122 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2024to 30 Jul 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Field health personnel (FHP) with help of ASHA (a healthcare network in rural areas) will visit household and collect mobile phone numbers in Varanasi.
Who may be able to join
- Positive for any one or more of the following:
- All individuals aged above 18 years positive for habits (smoking and smokeless tobacco, chewing betel leaf, areca nut, paan masala, and/or regular use of alcohol)
- Clinical signs/symptoms (non-healing ulcers, white/ red/red \& white patches in the mouth, restriction of mouth opening and swelling of the neck)
- All individuals aged above 40 irrespective of habit/oral lesions
Who cannot join
- Individuals already diagnosed with oral cancer and undergoing treatment for oral cancer
- Under treatment for tuberculosis or suffering from any acute illness/ debilitating systemic disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065
Milind Rajadhyaksha, PhD, 646-608-2364
About this study
Mobile health (mHealth) will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers. This program is inclusive of long term surveillance to downstage oral cancer in India
- Conditions
- Smoking, Smoking, Cigarette, Smoking, Tobacco, Betel Chewer's Mucosa, Tobacco Use, Tobacco Smoking
- Being tested
- mHealth
- Keywords
- smoking, smoking, cigarette, smoking, tobacco, smokeless tobacco, betel leaf, areca nut, paan masala, alcohol use, Memorial Sloan Kettering Cancer Center, 24-148
- Medical subject headings
- Smoking, Cigarette Smoking, Tobacco Smoking, Tobacco Use, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthDiagnostic test
Also called Mobile Health
The mobile health (mHealth) program will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers.
| Study group | Role | What they receive |
|---|---|---|
| Participants from Varanasi | Participants will be recruited from Varanasi. Receives: Diagnostic Test: mHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mHealth with conventional oral cancer screening
To compare the efficacy of conventional screening with mHealth in identification of oral potentially malignant disorders (OPMDs) / oral cancer.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start30 Jul 2024
- Primary completion30 Jul 2031 (estimated)
- Study completion30 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milind Rajadhyaksha, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535867
- Sponsor's protocol ID
- 24-148
- Status last verified
- May 2026
- First submitted
- 30 Jul 2024
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study
- ClinicalTrials.gov ID
- NCT06535867
- Acronym / sponsor ID
- 24-148
- Conditions
- Smoking, Smoking, Cigarette, Smoking, Tobacco, Betel Chewer's Mucosa, Tobacco Use, Tobacco Smoking
- Keywords
- smoking, smoking, cigarette, smoking, tobacco, smokeless tobacco, betel leaf, areca nut, paan masala, alcohol use
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,122 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jul 2031 (estimated)
- Study completion
- 30 Jul 2031 (estimated)
- First posted
- 2 Aug 2024 (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.
Mobile health (mHealth) will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers. This program is inclusive of long term surveillance to downstage oral cancer in India
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants from Varanasi | – | Diagnostic Test: mHealthParticipants will be recruited from Varanasi. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Field health personnel (FHP) with help of ASHA (a healthcare network in rural areas) will visit household and collect mobile phone numbers in Varanasi.
Key inclusion criteria (4 listed)
- All individuals aged above 18 years positive for habits (smoking and smokeless tobacco, chewing betel leaf, areca nut, paan masala, and/or regular use of alcohol)
- Clinical signs/symptoms (non-healing ulcers, white/ red/red \& white patches in the mouth, restriction of mouth opening and swelling of the neck)
- All individuals aged above 40 irrespective of habit/oral lesions
Key exclusion criteria (2 listed)
- Individuals already diagnosed with oral cancer and undergoing treatment for oral cancer
- Under treatment for tuberculosis or suffering from any acute illness/ debilitating systemic disorders
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 |
|---|---|---|
| mHealthAlso: Mobile HealthThe mobile health (mHealth) program will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers. | Diagnostic test | Participants from Varanasi |
Primary outcome
Comparison of mHealth with conventional oral cancer screening
Time frame: Up to 5 years
To compare the efficacy of conventional screening with mHealth in identification of oral potentially malignant disorders (OPMDs) / oral cancer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Milind Rajadhyaksha, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Smoking, Cigarette, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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 United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milind Rajadhyaksha, PhD (646-608-2364, rajadhym@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of mHealth with conventional oral cancer screening (time frame: Up to 5 years). 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 22 May 2026.