FindTrial
Sign In

Genetics of margin-negative Oral Squamous Cell Carcinoma surgical resection.

Identification of genetic predictors responsible for local failure in margin-negative Oral Squamous Cell Carcinoma patients in India. - INDIGO-Predict

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/11/060253
Enrollment
100
Registered
2023-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: C060- Malignant neoplasm of cheek mucosa

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Treatment Naïve, Histologically, biopsy proven Oral Squamous cell Carcinoma of the Buccal Mucosa, alveolus, retromolar trigone. 2. Surgically resectable with R0 margins, across stages T1 -T4b. 3. Specimen Closest Gross margins more than 5 mm mucosal/ soft tissue. 4. Surgically treatable OSCC planned for treatment at any center of Tata Memorial Center.

Exclusion criteria

Exclusion criteria: 1. Previously treated for Head neck cancer/ Oral Cancer 2. Tongue, floor of mouth, Hard palate subsite 3. Specimen closest margins of gross 4. Unresctable Oral Squamous cell carcinoma or in cases where R0 resection not feasible 5. Patients on any non-standard treatment protocol- or enrolled in other study effecting outcome 6. Patients with known hereditary conditions with increased risk of Oral Squamous Cell Carcinoma 7. Premalignant lesions/conditions, suspect malignancies, or carcinoma in-situ

Design outcomes

Primary

MeasureTime frame
Functional genomics at DNA level using NGS-based targeted sequencing with 1200 gene panel of tumor + margin+ adjacent normal and blood from surgically resected (with tumor-free margin) of BMSCC patients.Timepoint: 4-6 weeks from the date of surgery of the enrolled patients—

Secondary

MeasureTime frame
3. Analytical aspect - The analysed data from recurrent cases will be aligned with non-recurrent ones to identify the predictor variant(s). Variants present in only recurrent cases (fulfilling statistical significance) will be pin-pointed. 4. Validation and adoption in clinical setting – the identified variants will be cross-validated by liquid biopsy in recurrent patients (whether commonly observed at cfDNA level) and eventually those variants could be used as risk-predictor and treatment management by the surgeon. Timepoint: 50 cases in 1st year 50 cases in 2nd year 20 cases in 3rd year (recurrent only) for LB—

Countries

India

Contacts

Public ContactBurhanuddin Nuruddin Qayyumi

Homi Bhabha Cancer Hospital and Research Center, Tata Memorial Center

qburhan@gmail.com9566170436

Outcome results

None listed

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