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NCT02543476 · ClinicalTrials.gov registry record
SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
A clinical trial, sponsored by AstraZeneca.
- Completed
- Registry status
- 412
- Enrollment target
NCT02543476: Completed study, sponsored by AstraZeneca.
NCT02543476 is a clinical trial that has completed, run by AstraZeneca. The registered enrollment target is 412 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02543476 has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- 412 participants
- Enrollment target
Study Summary
This is a retrospective international, multi-center, non-interventional cohort study based on use of data derived from established medical records and secondary analysis of archival tumor samples. The study will collect data on patient and tumor characteristics, PD-L1 status, patterns of treatment, and clinical outcomes, in up to 600 adult patients with recurrent/metastatic SCCHN. SCCHN of interest for this study are defined as the diseases falling into specific ICD-10 or International Classification of Diseases, Ninth Revision (ICD-9) codes (Table 1), depending on anatomical sub-site of the primary tumor. For patient selection, the date of diagnosis of recurrent/metastatic disease will be used as the index date. The patient selection period extends from the 1st March 2011 to the 30th June 2015. This allows for the inclusion of patients with tumor samples of approximately ≤ 5 years age, and ensures approximately 10 months follow-up for living patients recruited at last day of the enrollment window. All patients with a diagnosis of recurrent/metastatic SCC of the oral cavity (tongue, gum, floor of mouth, and other/unspecified part of the mouth), oropharynx, hypopharynx, or larynx during that period will be considered for inclusion in the study (Figure 1). Patients will be identified and followed up through their medical records until death or end of data collection in approximately 20 centers in the US, Asia and Europe. Patients' demographic, clinical characteristics, and medical history will be described. Clinical outcomes including PFS, best response, duration of response, and ORR will be described for the first line and second line of therapy (if any), and OS will be collected A mandatory archived tumor samples will be used to determine PD-L1 status. If a patient has more than one suitable tissue sample, the most recent sample will be used as the mandatory tissue sample. Where available, additional tumor samples obtained at any other time points of the disease w
Primary Outcome
PD-L1 status: positive-negative status measured on tumor slides. Positivity corresponds to more than 25% of tumor cells with membrane positivity for PD-L1. The primary objective of this study is to estimate the prognostic value of PD-L1 status in terms of OS in patients with recurrent/metastatic SCCHN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2015-09-16 |
| Est. Completion | 2016-11-14 |
What the finished NCT02543476 record still lists
NCT02543476 is an observational study that tracks outcomes without assigning an intervention. The registered 412 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02543476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02543476 about?
NCT02543476 is a clinical study titled "SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)". This is a retrospective international, multi-center, non-interventional cohort study based on use of data derived from established medical records and secondary analysis of archival tumor samples. The study will collect data on patient and tumor characteristics, PD-L1 status, patterns of treatment, ...
What is the current status of trial NCT02543476?
This trial is currently completed. The enrollment target is 412 participants. The study started on 2015-09-16. Estimated completion is 2016-11-14.
Who is sponsoring clinical trial NCT02543476?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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