Nasopharyngeal CarcinomaNCT02501993
Nasopharyngeal Carcinoma Screening in Zhongshan City
An observational study of Nasopharyngeal Carcinoma, run by Zhongshan People's Hospital, Guangdong, China at 1 site in China.
Trial summary
The primary objective is to determine the early diagnosis rate and mortality rate of the Nasopharyngeal Carcinoma (NPC) in the study population. The secondary objective is to determine the incidence of NPC in the study population. Read more about this study
- Who is it for?
- Ages 30 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma
- How many people
- 25,000 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Dec 2023
- 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 30 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Residents of Zhongshan City
Who may be able to join
- Subject residents in Zhongshan city
- Subject is 30 to 59 years of age inclusive
- Subject has no medical record of nasopharyngeal carcinoma
- ECOG 0-2
- Subject has psychical condition and well consciousness
- Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
Who cannot join
- Subject has heavy cardiovascular, liver or kidney disease
- Subject has medical record of nasopharyngeal carcinoma
- Subject who is not residing in Zhongshan City
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serology Screening Test for the Detection of Nasopharyngeal Carcinoma in Zhongshan City
The primary objective is to determine the early diagnosis rate and mortality rate of the Nasopharyngeal Carcinoma (NPC) in the study population.
The secondary objective is to determine the incidence of NPC in the study population.
Read the detailed description
The research is to evaluate the effect of NPC screening, also as an extended study of Screening for Nasopharyngeal Carcinoma in High Risk Populations (NCT00941538).
The program was conducted in Xiaolan and Minzhong towns of Zhongshan city in 2012.
All participants will be tested for anti-EBV antibody by using serum samples. Participants are stratified into those having high, moderate and low antibody levels, those having moderate antibody levels are invited to retest annually in the following 3 years and those found to have high antibody levels on these occasions are referred to centers for diagnostic workup for NPC.
- Conditions
- Nasopharyngeal Carcinoma
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Screening cohort | All participants will be tested for anti-EBV antibody by using serum samples. Participants are stratified into those having high, moderate and low antibody levels, those having moderate antibody levels are invited to retest annually in the following 3 years and those found to have high antibody levels on these occasions are referred to centers for diagnostic workup for NPC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The early detection rate (stage I and II) of Nasopharyngeal Carcinoma
Measured: 10 years
The mortality rate of Nasopharyngeal Carcinoma
Measured: 10 years
Secondary outcomes (1)
The incidence of Nasopharyngeal Carcinoma
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startMar 2012
- Primary completionDec 2019
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingfang Ji, Zhongshan People's Hospital, Guangdong, China
- Investigators
- Mingfang Ji, MD, Principal investigator, Zhongshan People's Hospital, Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501993
- Sponsor's protocol ID
- NPC-PRO-002
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2015
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serology Screening Test for the Detection of Nasopharyngeal Carcinoma in Zhongshan City
- ClinicalTrials.gov ID
- NCT02501993
- Acronym / sponsor ID
- NPC-PRO-002
- Conditions
- Nasopharyngeal Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, ChinaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Jul 2015 (estimated)
- 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 primary objective is to determine the early diagnosis rate and mortality rate of the Nasopharyngeal Carcinoma (NPC) in the study population.
The secondary objective is to determine the incidence of NPC in the study population.
Detailed description
The research is to evaluate the effect of NPC screening, also as an extended study of Screening for Nasopharyngeal Carcinoma in High Risk Populations (NCT00941538).
The program was conducted in Xiaolan and Minzhong towns of Zhongshan city in 2012.
All participants will be tested for anti-EBV antibody by using serum samples. Participants are stratified into those having high, moderate and low antibody levels, those having moderate antibody levels are invited to retest annually in the following 3 years and those found to have high antibody levels on these occasions are referred to centers for diagnostic workup for NPC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening cohort | – | –All participants will be tested for anti-EBV antibody by using serum samples. Participants are stratified into those having high, moderate and low antibody levels, those having moderate antibody levels are invited to retest annually in the following 3 years and those found to have high antibody levels on these occasions are referred to centers for diagnostic workup for NPC. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents of Zhongshan City
Key inclusion criteria (6 listed)
- Subject residents in Zhongshan city
- Subject is 30 to 59 years of age inclusive
- Subject has no medical record of nasopharyngeal carcinoma
- ECOG 0-2
- Subject has psychical condition and well consciousness
Key exclusion criteria (3 listed)
- Subject has heavy cardiovascular, liver or kidney disease
- Subject has medical record of nasopharyngeal carcinoma
- Subject who is not residing in Zhongshan City
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The early detection rate (stage I and II) of Nasopharyngeal Carcinoma
Time frame: 10 years
The mortality rate of Nasopharyngeal Carcinoma
Time frame: 10 years
1 secondary outcome
The incidence of Nasopharyngeal Carcinoma
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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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.
Mingfang Ji, MD principal investigator
Zhongshan People's Hospital, Guangdong, China
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 Zhongshan People's Hospital, Guangdong, China 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Jul 2023. 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?
Results are not available in the source record.
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?
The early detection rate (stage I and II) of Nasopharyngeal Carcinoma (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2023.