NCT03989297

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

2.9 years

First QC Date

June 14, 2019

Last Update Submit

September 1, 2020

Conditions

Keywords

nasopharyngeal carcinomaprogrammed death-ligand 1prognosis

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Efficacy after radiation

    Followed up with 12 months after last patient in

Secondary Outcomes (1)

  • Survival rate

    Followed up with 12 months after last patient in

Study Arms (1)

NPC patients

Consecutive patients who were pathologically diagnosed with NPC and for whom fresh-frozen tissue samples were available were included.

Radiation: Radiation

Interventions

RadiationRADIATION

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

NPC patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kiang Wu Hospital

Macao, 999078, China

Location

Related Publications (1)

  • Cao Y, Chan KI, Xiao G, Chen Y, Qiu X, Hao H, Mak SC, Lin T. Expression and clinical significance of PD-L1 and BRAF expression in nasopharyngeal carcinoma. BMC Cancer. 2019 Oct 29;19(1):1022. doi: 10.1186/s12885-019-6276-y.

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiation

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Yabing Cao, MD; PhD

    Kiang Wu Hospital, Department of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2019

First Posted

June 18, 2019

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 30, 2019

Last Updated

September 2, 2020

Record last verified: 2020-09

Locations