Real-World Evidence and Treatment Patterns: Head and Neck Cancer
1 other identifier
observational
43,994
1 country
1
Brief Summary
This study will be focused on HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Typical duration for all trials
1 active site
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 Start
First participant enrolled
November 24, 2016
CompletedFirst Submitted
Initial submission to the registry
May 16, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2020
CompletedJanuary 5, 2024
January 1, 2024
2 years
May 16, 2017
January 4, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
Proportion of patients receiving radiotherapy as anti-cancer treatment
Approximately 45 months
Proportion of patients receiving surgery as anti-cancer treatment
Approximately 45 months
Proportion of patients receiving chemotherapy as anti-cancer treatment
Approximately 45 months
Proportion of patients receiving targeted therapy as anti-cancer treatment
Approximately 45 months
Proportion of patients receiving supportive care as anti-cancer treatment
Approximately 45 months
Distribution of Treatment History in Head and Neck Cancer (HNC) patients
Approximately 45 months
Secondary Outcomes (8)
Distribution of overall survival (OS) by age
Approximately 45 months
Distribution of overall survival (OS) by gender
Approximately 45 months
Distribution of overall survival (OS) by stage
Approximately 45 months
Distribution of overall survival (OS) by tumor site
Approximately 45 months
Distribution of overall survival (OS) by treatment regimen
Approximately 45 months
- +3 more secondary outcomes
Study Arms (1)
HNC patients
HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Ono Pharmaceutical Co. Ltdcollaborator
Study Sites (1)
Local Institution
Tokyo, Shibuya-ku, 150-0002, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2017
First Posted
May 17, 2017
Study Start
November 24, 2016
Primary Completion
December 5, 2018
Study Completion
April 20, 2020
Last Updated
January 5, 2024
Record last verified: 2024-01