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To compare the efficacy of different tests used for high risk Human Papilloma Virus detection in cases of Squamous cell carcinoma that have spread to neck lymph nodes

Comparative analysis of qPCR, mRNA ISH and p16 IHC for detection of high risk HPV on fine needle aspirates and core needle biopsies in patients with metastatic squamous cell carcinoma in cervical lymph nodes - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/09/074392
Enrollment
100
Registered
2024-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C102- Malignant neoplasm of lateral wallof oropharynx Health Condition 3: C109- Malignant neoplasm of oropharynx,unspecified Health Condition 4: C108- Malignant neoplasm of overlappingsites of oropharynx Health Condition 5: C103- Malignant neoplasm of posterior wall of oropharynx Health Condition 6: C051- Malignant neoplasm of soft palate Health Condition 7: C090- Malignant neoplasm of tonsillar fossa Health Condit

Interventions

Intervention1: FNAC and Core Needle Biopsy: FNAC and Core Needle Biopsy samples to be collected for HR-HPV testing Control Intervention1: p16 IHC: Other HR-HPV detection methods like mRNA-ISH and qPCR

Sponsors

Dr Anju K T
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients with cervical lymph node metastasis from oropharyngeal cancer or Carcinoma of Unknown Primary Site 2) FNAC and Core Needle Biopsy available 3) FNAC should have adequate tissue in cell blocks 4) Informed and written consent obtained

Exclusion criteria

Exclusion criteria: 1) Non squamous histology 2) Inadequate material for immunohistochemistry and mRNA ISH in cell blocks and biopsies

Design outcomes

Primary

MeasureTime frame
1)To assess HR HPV status in metastatic squamous cell carcinoma in cervical lymph nodes 2) To determine the ideal specimen to be obtained for determining HR HPV status in metastatic squamous cell carcinoma to cervical lymph nodes, FNAC v/s Core Needle Biopsy 3) To identify the best technique for detection of HR HPV in metastatic squamous cell carcinoma to cervical lymph nodesTimepoint: 1 year 8 months—

Secondary

MeasureTime frame
1) To determine the prevalence of HR HPV in metastatic squamous cell carcinoma to cervical lymph nodes with or without a clinically or radiologically detected primary lesion in oropharynxTimepoint: 1 year 8 months—

Countries

India

Contacts

Public ContactProf Chirom Amit Singh

All India Institute of Medical Sciences New Delhi

kaniyanthazath123@gmail.com9497181833

Outcome results

None listed

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