Nasopharyngeal CarcinomaNCT03989297
PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Carcinoma, run by Kiang Wu Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Radiation
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Enrolment in studies that prohibit any participation in this observational study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Radiation
- Keywords
- nasopharyngeal carcinoma, programmed death-ligand 1, prognosis
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Consecutive patients who were pathologically diagnosed with NPC and treated with radiation at the Kiang Wu Hospital.
| Study group | Role | What they receive |
|---|---|---|
| NPC patients | Consecutive patients who were pathologically diagnosed with NPC and for whom fresh-frozen tissue samples were available were included. Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Efficacy after radiation
Measured: Followed up with 12 months after last patient in
Secondary outcomes (1)
Survival rate
Survival in PD-L1 positive and negative group
Measured: Followed up with 12 months after last patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Jan 2017
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kiang Wu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yabing Cao, MD; PhD, Principal investigator, Kiang Wu Hospital, Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989297
- Sponsor's protocol ID
- KWH201701
- Status last verified
- Sep 2020
- First submitted
- 14 Jun 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31664962
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression and Clinical Significance of PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03989297
- Acronym / sponsor ID
- KWH201701
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- nasopharyngeal carcinoma, programmed death-ligand 1, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Kiang Wu HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPC patients | – | Radiation: RadiationConsecutive patients who were pathologically diagnosed with NPC and for whom fresh-frozen tissue samples were available were included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Enrolment in studies that prohibit any participation in this observational study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiationConsecutive patients who were pathologically diagnosed with NPC and treated with radiation at the Kiang Wu Hospital. | Radiation | NPC patients |
Primary outcome
Response rate
Time frame: Followed up with 12 months after last patient in
Efficacy after radiation
1 secondary outcome
Survival rate
Time frame: Followed up with 12 months after last patient in
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Derived from this study: PubMed 31664962Cao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yabing Cao, MD; PhD principal investigator
Kiang Wu Hospital, Department of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma, run by Kiang Wu Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Followed up with 12 months after last patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03989297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.