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NCT Number: NCT05382585

Newer Therapeutic Targets in Head and Neck Cancers

Based on the recently identified mutations in HNSCCs, the major pathologic pathways implicated in the tumorigenesis of HNSCC include dysregulation of four processes:

1. cellular survival and proliferation (e.g., TP53, EGFR, MET, and PIK3CA); 2. cell-cycle control (e.g., CDKN2A and CCND1); 3. cellular differentiation (e.g., NOTCH1); and 4. Adhesion and invasion signaling (e.g., FAT1).7 TP53, EGFR, PIK3CA, CDKN2A, CCND1, and MET participate in several common signaling pathways.

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

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Key information

Conditions

Head Neck Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oral Cancer Stomatognathic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Banaras Hindu University

Varanasi, Uttar Pradesh, 221005, India

Location status: Recruiting

Location contact

Keshav Murthy, MS

CONTACT

[email protected]

9035424293

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically proven cases of primary head and neck cancers.

Exclusion criteria

  • Patients under 18 years of age
  • Pregnant and lactating women
  • Multiple cancers or patients with cancer of other sites.

Treatment and study plan

next generation sequencing

Other

Next generation sequencing for 161 genes

Primary outcomes

  1. Over all survival

    Time frame: 10 years

    Survival time from the diagnosis to death

  2. Relapse free survival

    Time frame: 10 years

    survival time from diagnosis to recurrence or metastasis

Secondary outcomes

  1. Progression free survival

    Time frame: 5 years

    The time from the diagnosis to progression of disease

Study contacts

Contact information is provided by the study sponsor or research team.

Manoj Pandey, MS, PhD

CONTACT

[email protected]

9336363640

Sponsors and collaborators

Lead sponsor

Banaras Hindu University

Other

Registry information

Official study title

A Cohort Study to Identify Newer Therapeutic Targets in Head and Neck Cancers

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
May 19, 2022
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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