Newer Therapeutic Targets in Head and Neck Cancers

NCT ID: NCT05382585

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2027-12-31

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).

Conditions

Head Neck Cancer; Oral Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Head neck cancer

Histologically diagnosed cases of head and neck cancer

Next generation Sequencing

Intervention Type: OTHER

Next generation sequencing for 161 genes

Interventions

Next generation Sequencing

Next generation sequencing for 161 genes

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Banaras Hindu University

OTHER

Sponsor Role: lead

Responsible Party

Manoj Pandey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manoj Pandey, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Banaras Hindu University

Varanasi, Uttar Pradesh, India

Site Status: RECRUITING

Countries

India

Central Contacts

Manoj Pandey, MS, PhD

Role: CONTACT

manojpandey66@gmail.com

9336363640

Facility Contacts

Keshav Murthy, MS

Role: primary

keshav.murthy.bmcri@gmail.com

9035424293

References

Batta N, Pandey M. Mutational spectrum of tobacco associated oral squamous carcinoma and its therapeutic significance. World J Surg Oncol. 2019 Nov 27;17(1):198. doi: 10.1186/s12957-019-1741-2.

Reference Type: RESULT

PMID: 31775759 (View on PubMed)

Study Documents

Document Type: Mutation data

Data of 37 mutations identified till 2020 has been uploaded, more mutations will be uploaded soon

View Document

Other Identifiers

NGSHN1

Identifier Type: -

Identifier Source: org_study_id