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
Completed
Conditions studied: Squamous Cell Carcinoma of the Head and Neck
In brief
The purpose of this observational study is to collect real-world data that describes treatment patterns and clinical outcomes in participants with first line recurrent/metastatic squamous cell carcinoma of the head \& neck (1L R/M SCCHN).
Key facts
- Study ID
- NCT05123950
- Run by
- Bristol-Myers Squibb
- People needed
- 304
- Starts
- 2019-01-01
- Expected to finish
- 2021-03-19
- Last updated by the study team
- 2021-11-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants are included in Cohort 1 - Augment if they meet the following 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
You may not qualify if…
- Participants were excluded from either cohort if they meet the following 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).
Where it is running
- Medical Data Analytics — Parsippany, New Jersey, United States
Full record on ClinicalTrials.gov
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