Head & Neck CancerNCT03157674
Real-World Evidence and Treatment Patterns: Head and Neck Cancer
An observational study of Head & Neck Cancer, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
This study will be focused on HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head & Neck Cancer
- What is being tested?
- Non-Interventional
- How many people
- 43,994 participants
- Where
- 1 siteJapan
- Study dates
- 24 Nov 2016to 20 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study will be focused on HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016.
- Conditions
- Head & Neck Cancer
- Being tested
- Non-Interventional
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| HNC patients | HNC patients who have been diagnosed with HNC between
01-Jan-2013 and 30-Sep-2016. Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients receiving radiotherapy as anti-cancer treatment
Measured: Approximately 45 months
Proportion of patients receiving surgery as anti-cancer treatment
Measured: Approximately 45 months
Proportion of patients receiving chemotherapy as anti-cancer treatment
Measured: Approximately 45 months
Proportion of patients receiving targeted therapy as anti-cancer treatment
Measured: Approximately 45 months
Proportion of patients receiving supportive care as anti-cancer treatment
Measured: Approximately 45 months
Distribution of Treatment History in Head and Neck Cancer (HNC) patients
Measured: Approximately 45 months
Secondary outcomes (8)
Distribution of overall survival (OS) by age
Measured: Approximately 45 months
Distribution of overall survival (OS) by gender
Measured: Approximately 45 months
Distribution of overall survival (OS) by stage
Measured: Approximately 45 months
Distribution of overall survival (OS) by tumor site
Measured: Approximately 45 months
Distribution of overall survival (OS) by treatment regimen
Measured: Approximately 45 months
Number of treatment-limiting adverse events (AEs)
Incidence of important treatment-limiting adverse events (AEs) associated with systemic therapies
Measured: Approximately 45 months
Number of withdrawals due to AEs
Measured: Approximately 45 months
Proportion of diagnosis of another malignancy on or before the initial diagnosis of HNC
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start24 Nov 2016
- Primary completion5 Dec 2018
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43,994 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157674
- Sponsor's protocol ID
- CA209-868
- Status last verified
- Jan 2024
- First submitted
- 16 May 2017
- Last updated
- 5 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evidence and Treatment Patterns: Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03157674
- Acronym / sponsor ID
- CA209-868
- Conditions
- Head & Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43,994 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 24 Nov 2016 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be focused on HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HNC patients | – | Other: Non-InterventionalHNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | HNC patients |
Primary outcome
Proportion of patients receiving radiotherapy as anti-cancer treatment
Time frame: Approximately 45 months
Proportion of patients receiving surgery as anti-cancer treatment
Time frame: Approximately 45 months
Proportion of patients receiving chemotherapy as anti-cancer treatment
Time frame: Approximately 45 months
Proportion of patients receiving targeted therapy as anti-cancer treatment
Time frame: Approximately 45 months
Proportion of patients receiving supportive care as anti-cancer treatment
Time frame: Approximately 45 months
Distribution of Treatment History in Head and Neck Cancer (HNC) patients
Time frame: Approximately 45 months
8 secondary outcomes
Distribution of overall survival (OS) by age
Time frame: Approximately 45 months
Distribution of overall survival (OS) by gender
Time frame: Approximately 45 months
Distribution of overall survival (OS) by stage
Time frame: Approximately 45 months
Distribution of overall survival (OS) by tumor site
Time frame: Approximately 45 months
Distribution of overall survival (OS) by treatment regimen
Time frame: Approximately 45 months
Number of treatment-limiting adverse events (AEs)
Time frame: Approximately 45 months
Number of withdrawals due to AEs
Time frame: Approximately 45 months
Proportion of diagnosis of another malignancy on or before the initial diagnosis of HNC
Time frame: At Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
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RecruitingPhase 2
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Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head & Neck Cancer, run by Bristol-Myers Squibb at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients receiving radiotherapy as anti-cancer treatment (time frame: Approximately 45 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.