Oral CancerNCT04494620
Evaluating Oral Visual Inspection in the Control of Oral Cancer
A study testing Visual Inspection of Oral Cavity for Precancers and Cancer in people with Oral Cancer, run by International Agency for Research on Cancer.
Trial summary
Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the effect of triennial screening for oral cavity cancer using visual inspection on oral cancer mortality. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Visual Inspection of Oral Cavity for Precancers and Cancer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191,873 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1996to 31 Dec 2014
- Phase
- Interventional
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Diagnosis with oral cancer prior to study
- Bedridden subjects
- Subjects suffering from open tuberculosis or other debilitating diseases
About this study
Official title: Randomized Intervention Trial to Evaluate Oral Visual Inspection in the Control of Oral Cancer
Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the effect of triennial screening for oral cavity cancer using visual inspection on oral cancer mortality.
Read the detailed description
The study population consisted of 13 administrative regions (clusters) in Trivandrum district, Kerala, southern Indian. 7 clusters were randomly assigned to the intervention arm (3 rounds of oral visual inspection conducted 3 years apart) and were compared to the remaining 6 clusters assigned to a control arm that received standard of care. The eligibility criteria were all healthy subjects aged 35 and older, without a personal history of oral cancer. Informed consent was signed by each participant. The intervention arm consisted of 96,517 participants and the control group consisted of 95,356 participants.
- Conditions
- Oral Cancer
- Being tested
- Visual Inspection of Oral Cavity for Precancers and Cancer
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Inspection of Oral Cavity for Precancers and CancerDiagnostic test
Participants were invited for 3 rounds of oral cavity cancer screening, conducted 3-years apart. Screening was conducted by health workers trained to perform visual inspection of the oral mucosa and identify potential precancerous lesions or oral cancer. Lesions found were referred to a weekly clinic for further evaluation by dentists and oncologists with experience in the diagnosis of oral lesions. Oral precancerous lesions were surgically excised whenever possible and those with confirmed oral cancer were referred for appropriate treatment with surgery, radiotherapy, and/or chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Standard of Care |
| Intervention Arm | Active comparator | Visual Inspection of Oral Cavity for Precancers and Cancer Receives: Diagnostic Test: Visual Inspection of Oral Cavity for Precancers and Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Cancer Death Rate
Information on all deaths were collected from the municipal and district death registers, hospital medical records, death records of churches and mosques, hospital visits by the population cancer registry staff and by project health workers. Cancer cases were coded by the ICD-O 3rd edition codes and cause of death was coded using ICD-10 by the registry and project staff blinded to study group allocation. Deaths were attributed to oral cancer if the patient had histologically or clinically confirmed oral cancer, lymph nodes or distant metastasis at the time of death or had died due to complications of oral cancer treatment.
Measured: 15 years
Secondary outcomes (1)
Oral Cavity Cancer Incidence
Information on incident oral cancer cases were obtained from the Trivandrum population-based cancer registry, hospital cancer registry of the RCC and medical records departments of other hospitals treating oral cancer patients. Collection of information was blinded to study group assignment of cases. The staging of oral cancers was done according to the UICC TNM staging system.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Jan 1996
- Primary completion31 Dec 2004
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The control group received standard of care while the intervention group received 3 rounds of screening with visual inspection, each 3 years apart. At the 9th year of the study, once significant oral cancer mortality reduction following 3 rounds of screening among the high-risk subjects in the intervention arm was confirmed, the control arm was offered 1 round of screening with visual inspection while the intervention group was offered a 4th round of screening.
- Masking
- None (open label)
- Enrolment
- 191,873 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Cancer Centre, Trivandrum, India
- Responsible party
- Sponsor
- Investigators
- Kunnambath Ramadas, MD, PhD, Principal investigator, Regional Cancer Centre, Trivandrum, IndiaRengaswamy Sankaranarayanan, MD, Principal investigator, International Agency for Research on Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494620
- Sponsor's protocol ID
- RCC-IEC-Sept 2002
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sankaranarayanan R, Ramadas K, Thara S, Muwonge R, Thomas G, Anju G, Mathew B. Long term effect of visual screening on oral cancer incidence and mortality in a randomized trial in Kerala, India. Oral Oncol. 2013 Apr;49(4):314-21. doi: 10.1016/j.oraloncology.2012.11.004. Epub 2012 Dec 21.
PubMed 23265945Sankaranarayanan R, Ramadas K, Thomas G, Muwonge R, Thara S, Mathew B, Rajan B; Trivandrum Oral Cancer Screening Study Group. Effect of screening on oral cancer mortality in Kerala, India: a cluster-randomised controlled trial. Lancet. 2005 Jun 4-10;365(9475):1927-33. doi: 10.1016/S0140-6736(05)66658-5.
PubMed 15936419Cheung LC, Chen G, Muwonge R, Reeve M, Thomas G, Somanathan T, Mao F, Pan Q, Basu P, Sankaranarayanan R, Ramadas K, Chaturvedi AK. Clinical and lifetime natural history of oral cancer: implications for screening and surveillance. J Natl Cancer Inst. 2026 Oct 7:djag360. doi: 10.1093/jnci/djag360. Online ahead of print.
PubMed 42842394Cheung LC, Ramadas K, Muwonge R, Katki HA, Thomas G, Graubard BI, Basu P, Sankaranarayanan R, Somanathan T, Chaturvedi AK. Risk-Based Selection of Individuals for Oral Cancer Screening. J Clin Oncol. 2021 Feb 20;39(6):663-674. doi: 10.1200/JCO.20.02855. Epub 2021 Jan 15.
PubMed 33449824
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Intervention Trial to Evaluate Oral Visual Inspection in the Control of Oral Cancer
- ClinicalTrials.gov ID
- NCT04494620
- Acronym / sponsor ID
- RCC-IEC-Sept 2002
- Conditions
- Oral Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191,873 participants (actual)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- Regional Cancer Centre, Trivandrum, India
- Study start
- 1 Jan 1996 (actual)
- Primary completion
- 31 Dec 2004 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 31 Jul 2020 (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.
Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the effect of triennial screening for oral cavity cancer using visual inspection on oral cancer mortality.
Detailed description
The study population consisted of 13 administrative regions (clusters) in Trivandrum district, Kerala, southern Indian. 7 clusters were randomly assigned to the intervention arm (3 rounds of oral visual inspection conducted 3 years apart) and were compared to the remaining 6 clusters assigned to a control arm that received standard of care. The eligibility criteria were all healthy subjects aged 35 and older, without a personal history of oral cancer. Informed consent was signed by each participant. The intervention arm consisted of 96,517 participants and the control group consisted of 95,356 participants.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The control group received standard of care while the intervention group received 3 rounds of screening with visual inspection, each 3 years apart. At the 9th year of the study, once significant oral cancer mortality reduction following 3 rounds of screening among the high-risk subjects in the intervention arm was confirmed, the control arm was offered 1 round of screening with visual inspection while the intervention group was offered a 4th round of screening.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Standard of Care |
| Intervention Arm | Active comparator | Diagnostic Test: Visual Inspection of Oral Cavity for Precancers and CancerVisual Inspection of Oral Cavity for Precancers and Cancer |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Diagnosis with oral cancer prior to study
- Bedridden subjects
- Subjects suffering from open tuberculosis or other debilitating diseases
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 |
|---|---|---|
| Visual Inspection of Oral Cavity for Precancers and CancerParticipants were invited for 3 rounds of oral cavity cancer screening, conducted 3-years apart. Screening was conducted by health workers trained to perform visual inspection of the oral mucosa and identify potential precancerous lesions or oral cancer. Lesions found were referred to a weekly clinic for further evaluation by dentists and oncologists with experience in the diagnosis of oral lesions. Oral precancerous lesions were surgically excised whenever possible and those with confirmed oral cancer were referred for appropriate treatment with surgery, radiotherapy, and/or chemotherapy. | Diagnostic test | Intervention Arm |
Primary outcome
Oral Cancer Death Rate
Time frame: 15 years
Information on all deaths were collected from the municipal and district death registers, hospital medical records, death records of churches and mosques, hospital visits by the population cancer registry staff and by project health workers. Cancer cases were coded by the ICD-O 3rd edition codes and cause of death was coded using ICD-10 by the registry and project staff blinded to study group allocation. Deaths were attributed to oral cancer if the patient had histologically or clinically confirmed oral cancer, lymph nodes or distant metastasis at the time of death or had died due to complications of oral cancer treatment.
1 secondary outcome
Oral Cavity Cancer Incidence
Time frame: 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Results publication: PubMed 23265945Sankaranarayanan R, Ramadas K, Thara S, Muwonge R, Thomas G, Anju G, Mathew B. Long term effect of visual screening on oral cancer incidence and mortality in a randomized trial in Kerala, India. Oral Oncol. 2013 Apr;49(4):314-21. doi: 10.1016/j.oraloncology.2012.11.004. Epub 2012 Dec 21.
- Results publication: PubMed 15936419Sankaranarayanan R, Ramadas K, Thomas G, Muwonge R, Thara S, Mathew B, Rajan B; Trivandrum Oral Cancer Screening Study Group. Effect of screening on oral cancer mortality in Kerala, India: a cluster-randomised controlled trial. Lancet. 2005 Jun 4-10;365(9475):1927-33. doi: 10.1016/S0140-6736(05)66658-5.
- Derived from this study: PubMed 42842394Cheung LC, Chen G, Muwonge R, Reeve M, Thomas G, Somanathan T, Mao F, Pan Q, Basu P, Sankaranarayanan R, Ramadas K, Chaturvedi AK. Clinical and lifetime natural history of oral cancer: implications for screening and surveillance. J Natl Cancer Inst. 2026 Oct 7:djag360. doi: 10.1093/jnci/djag360. Online ahead of print.
- Derived from this study: PubMed 33449824Cheung LC, Ramadas K, Muwonge R, Katki HA, Thomas G, Graubard BI, Basu P, Sankaranarayanan R, Somanathan T, Chaturvedi AK. Risk-Based Selection of Individuals for Oral Cancer Screening. J Clin Oncol. 2021 Feb 20;39(6):663-674. doi: 10.1200/JCO.20.02855. Epub 2021 Jan 15.
- Individual participant dataSharing planned: No
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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.
Kunnambath Ramadas, MD, PhD principal investigator
Regional Cancer Centre, Trivandrum, India
Rengaswamy Sankaranarayanan, MD principal investigator
International Agency for Research on Cancer
Questions about this trial
What is this clinical trial studying?
A study testing Visual Inspection of Oral Cavity for Precancers and Cancer in people with Oral Cancer, run by International Agency for Research on Cancer.
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 0 inclusion and 3 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: finished, as of the sponsor's last update on 31 Jul 2020. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oral Cancer Death Rate (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04494620, which also lists 4 linked publications.
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 31 Jul 2020.