An observational study in Head Neck Cancer and Oral Cancer, sponsored by Banaras Hindu University. Recruiting at 1 site in India. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Banaras Hindu University · Observational
Based on the recently identified mutations in HNSCCs, the major pathologic pathways implicated in the tumorigenesis of HNSCC include dysregulation of four processes:
Alterations of these genes are most frequently seen in alcohol and tobacco-related HNSCC. However their role in prognostication and selection of therapeutics is not known
Sample size:
Patients with squamous cell carcinoma of oral cavity fulfilling the inclusion and exclusion criteria and willing to participate will be included in this study.
Method:
Comprehensive history and physical examination of the patients will be carried out and all the details will be recorded in the preset proforma. All routine investigations as indicated including a biopsy to establish a diagnosis and CT of the head and neck to measure the tumor dimensions and stage the disease before initiation of treatment will be recorded. The paraffin embedded tissue will be studied for expression of various genetic mutations using NGS platform. Brush cytology will be collected in liquid medium for HPV typing using PCR.
The Ion AmpliSeq™ Cancer Hotspot Panel v3 will be used to detect hotspot regions of 161 oncogenes and tumor suppressor genes This research panel, with improved primer design, contains 4,648 total 4 pools (DNA pool 1: 1,891 amplicons. DNA pool 2: 1,890 amplicons. RNA pool 1: 447 amplicons. RNA pool 2: 420 amplicons.), enabling researchers to sequence challenging samples of formalin-fixed, paraffin-embedded (FFPE) tissue. Copy Number Variants (CNVs), Gene Fusions, Insertions-Deletions (indels), Single Nucleotide Polymorphisms (SNPs), Somatic Variants are identified.
HPV DNA PCR METHODOLOGY
DNA will be isolated by using QIAamp DNA mini kit (Qiagen, Hilden, Germany). The presence of HPV will be detected by using the digene® HC2 HPV DNA Test- The digene HC2 HPV DNA Test uses Hybrid Capture 2 technology to detect high-risk and low-risk HPV genotypes. It uses in vitro microplate assay based on signal-amplified nucleic acid hybridization that uses chemiluminescence for the qualitative detection of 18 types of human papillomavirus (HPV) (13 high risk and 5 low risk) DNA in cervical specimens. The test uses an RNA probe cocktail that detects 13 high-risk HPV types (16/18/31/33/35/39/45/51/52/56/58/59/68) and 5 low-risk types (6/11/42/43/44).
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Banaras Hindu University is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Histologically proven cases of Head and neck cancer undergoing treatment will be included, Next generation sequencing will be done and cohort will be followed up for 10 years
Exclusion Criteria:
Histologically diagnosed cases of head and neck cancer
Other: Next generation Sequencing
Next generation sequencing for 161 genes
Over all survival
Survival time from the diagnosis to death
Time frame: 10 years
Relapse free survival
survival time from diagnosis to recurrence or metastasis
Time frame: 10 years
Progression free survival
The time from the diagnosis to progression of disease
Time frame: 5 years
Plan to share: Yes — On request
Supporting information: Study protocol, Sap, Icf, Csr
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Banaras Hindu University