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Testing saliva for early warning signs of oral and head neck cancers

Estimating the levels of salivary Pyruvate, Lactate and Citrate along with their corresponding ratios as diagnostic biomarkers for screening of oral potentially malignant disorders and head and neck cancers: A diagnostic accuracy study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/03/106240
Enrollment
228
Registered
2026-03-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Intervention5: Nil: Nil Intervention6: Nil: Nil

Sponsors

Dr Manohara A Bhat Y
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: o Adults aged 18 years or older with a voluntary informed consent to participate in the study o Clinically and histopathologically confirmed diagnosis of either malignant or potentially malignant disease as per medical records and confirmed by the Oncologist. o Apparently healthy controls of respective participants matched in terms of age, gender, BMI etc but no clinical evidence of any malignancy or potentially malignant disorders.

Exclusion criteria

Exclusion criteria: o Patients currently undergoing cancer treatment (chemotherapy, radiotherapy, or surgery). o Patients with chronic systemic diseases that might influence metabolism (e.g., diabetes, renal disease). o Pregnant or lactating women. o Individuals with acute infections or inflammatory conditions.

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of salivary pyruvate, lactate, and citrate levels, and their ratios in distinguishing oral potentially malignant disorders (OPMDs) and head and neck cancers (HNCs) from healthy controls.Timepoint: Present study is a cross-sectional, So only single time point salivary sample collection will be done.—

Secondary

MeasureTime frame
To compare the salivary levels and ratios of pyruvate, lactate, and citrate among healthy controls, patients with oral potentially malignant disorders (OPMDs), and patients with head and neck cancers (HNCs). To assess the correlation between salivary metabolite levels and disease stage or histopathological grade in OPMD and HNC groups. To evaluate the feasibility and acceptability of using salivary metabolite estimation as a non-invasive diagnostic and screening tool in clinical practice.Timepoint: Baseline (single time point): Saliva samples collected before initiation of any treatment or surgical intervention. Clinical and histopathological data recorded at diagnosis for correlation analysis. Feasibility and participant acceptability assessed during sample collection at baseline.—

Countries

India

Contacts

Public ContactDr Manohara A Bhat Y

Mysore Medical College and Research Institute, Mysore

manoharpangala@gmail.com08123389083

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026