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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03989297
Other study ID # KWH201701
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 30, 2019

Study information

Verified date September 2020
Source Kiang Wu Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date December 30, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Radiation:
Radiation
Consecutive patients who were pathologically diagnosed with NPC and treated with radiation at the Kiang Wu Hospital.

Locations

Country Name City State
China Kiang Wu Hospital Macao

Sponsors (1)

Lead Sponsor Collaborator
Kiang Wu Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate Efficacy after radiation Followed up with 12 months after last patient in
Secondary Survival rate Survival in PD-L1 positive and negative group Followed up with 12 months after last patient in
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