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OpenTrials
Completed

NCT Number: NCT03157674

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

This study will be focused on HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016.

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Key information

Conditions

Head & Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Tokyo, Shibuya-ku, 150-0002, Japan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. Proportion of patients receiving radiotherapy as anti-cancer treatment

    Time frame: Approximately 45 months

  2. Proportion of patients receiving surgery as anti-cancer treatment

    Time frame: Approximately 45 months

  3. Proportion of patients receiving chemotherapy as anti-cancer treatment

    Time frame: Approximately 45 months

  4. Proportion of patients receiving targeted therapy as anti-cancer treatment

    Time frame: Approximately 45 months

  5. Proportion of patients receiving supportive care as anti-cancer treatment

    Time frame: Approximately 45 months

  6. Distribution of Treatment History in Head and Neck Cancer (HNC) patients

    Time frame: Approximately 45 months

Secondary outcomes

  1. Distribution of overall survival (OS) by age

    Time frame: Approximately 45 months

  2. Distribution of overall survival (OS) by gender

    Time frame: Approximately 45 months

  3. Distribution of overall survival (OS) by stage

    Time frame: Approximately 45 months

  4. Distribution of overall survival (OS) by tumor site

    Time frame: Approximately 45 months

  5. Distribution of overall survival (OS) by treatment regimen

    Time frame: Approximately 45 months

  6. Number of treatment-limiting adverse events (AEs)

    Time frame: Approximately 45 months

    Incidence of important treatment-limiting adverse events (AEs) associated with systemic therapies

  7. Number of withdrawals due to AEs

    Time frame: Approximately 45 months

  8. Proportion of diagnosis of another malignancy on or before the initial diagnosis of HNC

    Time frame: At Baseline

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
May 17, 2017
Registry last updated
Jan 5, 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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