Real-World Evidence and Treatment Patterns: Head and Neck Cancer

January 4, 2024 updated by: Bristol-Myers Squibb
This study will be focused on HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

43994

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Shibuya-ku
      • Tokyo, Shibuya-ku, Japan, 150-0002
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients in the Medical Data Vision (MDV) database with a HNC diagnosis will be used to identify eligible subjects by applying the patient inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • HNC or undefined histology (not otherwise specified [NOS]) HNC diagnosis from 01-Jan-2013 to 30-Sep-2016 using Japanese disease code
  • Age 18 years or older at initial diagnosis of HNC regardless of staging

Exclusion Criteria:

  • Diagnosis of another malignancy on or before the initial diagnosis of HNC with the exception of non-melanoma skin cancer and metastatic cancer
  • Diagnosis of HNC before 01-Jan 2013 or after 30-Sep-2016

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HNC patients

HNC patients who have been diagnosed with HNC between

01-Jan-2013 and 30-Sep-2016.
Other: Non-Interventional
Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients receiving radiotherapy as anti-cancer treatment
Time Frame: Approximately 45 months
Approximately 45 months
Proportion of patients receiving surgery as anti-cancer treatment
Time Frame: Approximately 45 months
Approximately 45 months
Proportion of patients receiving chemotherapy as anti-cancer treatment
Time Frame: Approximately 45 months
Approximately 45 months
Proportion of patients receiving targeted therapy as anti-cancer treatment
Time Frame: Approximately 45 months
Approximately 45 months
Proportion of patients receiving supportive care as anti-cancer treatment
Time Frame: Approximately 45 months
Approximately 45 months
Distribution of Treatment History in Head and Neck Cancer (HNC) patients
Time Frame: Approximately 45 months
Approximately 45 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of overall survival (OS) by age
Time Frame: Approximately 45 months
Approximately 45 months
Distribution of overall survival (OS) by gender
Time Frame: Approximately 45 months
Approximately 45 months
Distribution of overall survival (OS) by stage
Time Frame: Approximately 45 months
Approximately 45 months
Distribution of overall survival (OS) by tumor site
Time Frame: Approximately 45 months
Approximately 45 months
Distribution of overall survival (OS) by treatment regimen
Time Frame: Approximately 45 months
Approximately 45 months
Number of treatment-limiting adverse events (AEs)
Time Frame: Approximately 45 months
Incidence of important treatment-limiting adverse events (AEs) associated with systemic therapies
Approximately 45 months
Number of withdrawals due to AEs
Time Frame: Approximately 45 months
Approximately 45 months
Proportion of diagnosis of another malignancy on or before the initial diagnosis of HNC
Time Frame: At Baseline
At Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2016

Primary Completion (Actual)

December 5, 2018

Study Completion (Actual)

April 20, 2020

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-868

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head & Neck Cancer

Clinical Trials on Non-Interventional

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe