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Oral cancer detection using saliva

SALIVARY DNA AS A DIAGNOSTIC TOOL IN ORAL CAVITY SQUAMOUS CELL CARCINOMA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/04/018664
Enrollment
30
Registered
2019-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C021- Malignant neoplasm of border of tongue Health Condition 2: C060- Malignant neoplasm of cheek mucosa Health Condition 3: C049- Malignant neoplasm of floor of mouth, unspecified Health Condition 4: C039- Malignant neoplasm of gum, unspecified Health Condition 5: C004- Malignant neoplasm of lower lip, inner aspect

Interventions

None listed

Sponsors

University of Chicago Trust in India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Oral Cavity Squamous cell carcinoma in Clinical stage I / II 2) Ability to understand the study and willing to give written informed consent 3) Eastern co-operative Oncology Group(ECOG) performance status 0-2 4) Treatment Naive patients. 5) Having primary treatment at Tata Memorial Centre

Exclusion criteria

Exclusion criteria: 1) Non-squamous histology 2) Underwent treatment for non OCSCC with any modality. 3) Underwent treatment for OCSCC with any modality. 4) Disease Recurrence and Second primary. 5) Not giving consent. 6) Pregnant patients.

Design outcomes

Primary

MeasureTime frame
To Create a biomarker gene panel that contains the most commonly occurring mutations in OCSCC.A foundational biomarker gene panel will be created based on research work that defined the mutational landscape of Head Neck Squamous Cell Carcinoma. This panel of founder mutations will function as the biomarkers for released tumor DNA in saliva derived from Oral Cavity Squamous Cell Carcinoma patients.Timepoint: at the completion of the study - 12 months

Secondary

MeasureTime frame
Validate founder mutations and evaluate the diagnostic and prognostic accuracy of rtDNA in saliva in the clinical settingTimepoint: 12 - 18 months

Countries

India

Contacts

Public ContactDr Sudhir V Nair

Tata Memorial Centre, Mumbai

sudhirvr@gmail.com02224177283

Outcome results

None listed

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