PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma

September 1, 2020 updated by: Kiang Wu Hospital

Expression and Clinical Significance of PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma

The prognostic value of programmed death-ligand 1 (PD-L1) and BRAF expression in nasopharyngeal carcinoma (NPC) is not well-defined. In this study the investigators investigated alterations in PD-L1, BRAF and EGFR by using immunohistochemistry analysis in a cohort of consecutively enrolled NPC patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

NPC is a common type cancer in Macau and Southern China. The role of PD-L1 in NPC remains controversial. There many reasons behind these inconsistent findings. We used the SP263 antibody with the standard cut off value of 1% and 5%, which is frequently used for lung cancer and other cancer types. We also plan to include over 150 patients, which will be the largest study in NPC. This will help us to gain insights in NPC.

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Macao, China, 999078
        • Kiang Wu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients who were pathologically diagnosed with NPC between 2006 and December 2010 at the Kiang Wu Hospital (Macau, SAR China) and for whom fresh-frozen tissue samples were available were included.

Description

Inclusion Criteria:

  • Above 18 years of age
  • Locally advanced (stage IIIB) or metastatic (stage IV) NPC
  • Fresh-frozen tissue samples were available were included
  • After treatment with curative surgery or radiotherapy in Macau
  • With follow up data were available

Exclusion Criteria:

• Enrolment in studies that prohibit any participation in this observational study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NPC patients
Consecutive patients who were pathologically diagnosed with NPC and for whom fresh-frozen tissue samples were available were included.
Radiation: Radiation
Consecutive patients who were pathologically diagnosed with NPC and treated with radiation at the Kiang Wu Hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: Followed up with 12 months after last patient in
Efficacy after radiation
Followed up with 12 months after last patient in

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: Followed up with 12 months after last patient in
Survival in PD-L1 positive and negative group
Followed up with 12 months after last patient in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kiang Wu Hospital

Investigators

  • Principal Investigator: Yabing Cao, MD; PhD, Kiang Wu Hospital, Department of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (Actual)

June 18, 2019

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KWH201701

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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