Newer Therapeutic Targets in Head and Neck Cancers

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Tongue neoplasm
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Brief Title

Newer Therapeutic Targets in Head and Neck Cancers

Official Title

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

Brief Summary

      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

Detailed Description

      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).

Study Type

Observational

Primary Outcome

Over all survival

Secondary Outcome

 Progression free survival

Condition

Head Neck Cancer

Intervention

Next generation Sequencing

Study Arms / Comparison Groups

 Head neck cancer
Description:  Histologically diagnosed cases of head and neck cancer

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

200

Start Date

April 1, 2017

Completion Date

December 31, 2027

Primary Completion Date

December 31, 2027

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Manoj Pandey, MS, PhD, 9336363640, [email protected]

Location Countries

India

Location Countries

India

Administrative Informations

NCT ID

NCT05382585

Organization ID

NGSHN1

Responsible Party

Principal Investigator

Study Sponsor

Banaras Hindu University

Study Sponsor

Manoj Pandey, MS, PhD, Principal Investigator, Professor

Verification Date

May 2022