NCT05382585

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Apr 2017Dec 2027

Study Start

First participant enrolled

April 1, 2017

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

10.8 years

First QC Date

May 16, 2022

Last Update Submit

August 9, 2024

Conditions

Keywords

Next generation sequencingpredictive biomarker

Outcome Measures

Primary Outcomes (2)

  • Over all survival

    Survival time from the diagnosis to death

    10 years

  • Relapse free survival

    survival time from diagnosis to recurrence or metastasis

    10 years

Secondary Outcomes (1)

  • Progression free survival

    5 years

Study Arms (1)

Head neck cancer

Histologically diagnosed cases of head and neck cancer

Other: Next generation Sequencing

Interventions

Next generation sequencing for 161 genes

Head neck cancer

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Histologically proven cases of primary head and neck cancers.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banaras Hindu University

Varanasi, Uttar Pradesh, 221005, India

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin embedded tissue

MeSH Terms

Conditions

Head and Neck NeoplasmsMouth Neoplasms

Interventions

High-Throughput Nucleotide Sequencing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sequence AnalysisGenetic TechniquesInvestigative Techniques

Study Officials

  • Manoj Pandey, MS, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manoj Pandey, MS, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 16, 2022

First Posted

May 19, 2022

Study Start

April 1, 2017

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

On request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
6 months
Access Criteria
On request

Available IPD Datasets

Mutation data Access

Locations