A Study of Treatment Patterns and Clinical Outcomes in First Line Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (1L R/M SCCHN) Participants in Europe
NCT ID: NCT05123950
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
304 participants
OBSERVATIONAL
2019-01-01
2021-03-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort 1
Participants diagnosed with R/M SCCHN between 01-Jan-2014 and 31-Dec-2016
No interventions assigned to this group
Cohort 1- Augment
Participants newly initiating 1L treatment for R/M SCCHN between 01-Jun-2017 and 01-Jun-2018
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Adults18 years or older
* Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx between 01-Jun-2017 and 31-June-2018.
* Prescribed 1L treatment for R/M SCCHN
* Treatment history and response available for medical chart abstraction from date of diagnosis until death or the end of the study in living participants
* Have available for review one month of follow-up data available post initiation of 1L R/M SCCHN therapy
* Informed consent form (ICF) signature/collection of living participants, as required by country regulation and local ethics committees
Participants are included in Cohort 1 if they meet the following criteria:
* Adults 18 years or older
* Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx and larynx between 01-Jan-2014 and 31-Dec-2016.
* Prescribed 1L treatment for R/M SCCHN
* Treatment history and response available for medical chart abstraction from the date of diagnosis until death or the end of the study in living participants
* Have available for review one month of follow-up data post initiation of 1L R/M SCCHN therapy
* Informed consent form (ICF) signature/collection of living participants, as required by country regulation and local ethics committees
Exclusion Criteria
* Were enrolled in a cancer treatment-related clinical trial since the diagnosis of R/M SCCHN
* Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary site, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma).
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Medical Data Analytics
Parsippany, New Jersey, United States
Countries
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Related Links
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BMS Clinical Trial Information
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CA209-8HX
Identifier Type: -
Identifier Source: org_study_id