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A Saliva Test to identify mouth Cancer and early mouth cancer Changes

Evaluation of Saliva Based Epithelial Mesenchymal Transition Multigene panel for early diagnosis of Oral Leukoplakia and Oral squamous cell carcinoma: A prospective study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/104336
Enrollment
90
Registered
2026-02-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C068- Malignant neoplasm of overlappingsites of other and unspecified parts of mouth

Interventions

Intervention1: Nil: Nil

Sponsors

Dr Manjula M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Group I Patients with histopathologically confirmed OSCC Any stage and grade No prior therapy surgery chemotherapy or radiotherapy Group II Histologically confirmed oral leukoplakia Aged 18 years and above Clinically and histologically confirmed as oral leukoplakia High Risk or Low Risk Oral epithelial Dysplasia Not previously treated for leukoplakia Group III Healthy control participants Age and sex matched individuals No clinical evidence of oral potentially malignant disorders OPMD or OSCC No history of tobacco or areca nut use Willingness to participate Signed informed consent Willing to provide saliva samples and undergo oral examination

Exclusion criteria

Exclusion criteria: Individuals with other oral potentially malignant disorders like OSMF erythroplakia lichen planus Patients who have received treatment for OSCC or leukoplakia previously Presence of systemic illness like uncontrolled diabetes autoimmune diseases chronic infections Inadequate saliva sample like insufficient volume or degraded RNA Pregnant or lactating women due to hormonal influences on gene expression Individuals unwilling or unable to comply with study procedures

Design outcomes

Primary

MeasureTime frame
This research will focus on an important public health problem in India of a persistent and incapacitating disease i.e. oral cancer and its predisposing premalignant state associated with habitual tobacco and areca nut useTimepoint: zero month six month one year

Secondary

MeasureTime frame
The concept of developing a noninvasive diagnostic gene expression panel of epithelial mesenchymal transition related transcriptomic genes in saliva for early detection , risk stratification & disease progression of oral leukoplakia & oral squamous cell carcinoma. Due to the potent role of EMT in the carcinogenesis, its evaluation may help in identification of high-risk lesions not diagnosed with routine histopathologic examinationTimepoint: Zero months six months one year

Countries

India

Contacts

Public ContactDr Manjula M

KAHER KLE VKIDS

punnyasanjay@gmail.com9880845530

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026