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出境医 / 临床实验 / PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma
PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Nasopharyngeal Carcinoma | Radiation: Radiation |
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 Design
| Study Type : | Observational |
| Actual Enrollment : | 104 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| Official Title: | Expression and Clinical Significance of PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma |
| Actual Study Start Date : | January 1, 2017 |
| Actual Primary Completion Date : | December 1, 2019 |
| Actual Study Completion Date : | December 30, 2019 |
Arms 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.
|
Outcome Measures
Primary Outcome Measures :
- Response rate [ Time Frame: Followed up with 12 months after last patient in ]Efficacy after radiation
Secondary Outcome Measures :
- Survival rate [ Time Frame: Followed up with 12 months after last patient in ]Survival in PD-L1 positive and negative group
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Contacts and Locations
Locations
| China | |
| Kiang Wu Hospital | |
| Macao, China, 999078 | |
Sponsors and Collaborators
Kiang Wu Hospital
Investigators
| Principal Investigator: | Yabing Cao, MD; PhD | Kiang Wu Hospital, Department of Oncology |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 14, 2019 | ||||
| First Posted Date | June 18, 2019 | ||||
| Last Update Posted Date | September 2, 2020 | ||||
| Actual Study Start Date | January 1, 2017 | ||||
| Actual Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Response rate [ Time Frame: Followed up with 12 months after last patient in ] Efficacy after radiation
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
Survival rate [ Time Frame: Followed up with 12 months after last patient in ] Survival in PD-L1 positive and negative group
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma | ||||
| Official Title | Expression and Clinical Significance of PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma | ||||
| 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. | ||||
| 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 | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition | Nasopharyngeal Carcinoma | ||||
| Intervention | Radiation: Radiation
Consecutive patients who were pathologically diagnosed with NPC and treated with radiation at the Kiang Wu Hospital.
|
||||
| Study Groups/Cohorts | NPC patients
Consecutive patients who were pathologically diagnosed with NPC and for whom fresh-frozen tissue samples were available were included.
Intervention: Radiation: Radiation
|
||||
| Publications * | 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. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
104 | ||||
| Original Estimated Enrollment |
199 | ||||
| Actual Study Completion Date | December 30, 2019 | ||||
| Actual Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: • Enrolment in studies that prohibit any participation in this observational study |
||||
| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03989297 | ||||
| Other Study ID Numbers | KWH201701 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Kiang Wu Hospital | ||||
| Study Sponsor | Kiang Wu Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
||||
| PRS Account | Kiang Wu Hospital | ||||
| Verification Date | September 2020 | ||||
