CancerEBVCRNCT06203314
Epstein-Barr Virus and Cancer Risks
An observational study of Cancer, run by Sun Yat-sen University at 2 sites in China.
Trial summary
The goal of this prospective cohort study is to investigate the associations between Epstein-Barr Virus (EBV) antibody levels and the risk of overall and site-specific cancer types in Southern China. Read more about this study
- Who is it for?
- Ages 30 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Diagnostic test: EBV antibody tests
- How many people
- 100,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2008to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30-69 years old healthy residences in Zhongshan City and Wuzhou City.
Who may be able to join
- Subject residents in Zhongshan or Wuzhou City;
- Subject has no medical record of prevalent cancer;
- Subject has psychical condition and well consciousness, and willingness to accept and cooperate with the study\'s follow-up procedures.
Who cannot join
- Subject has heavy cardiovascular, liver, or kidney disease;
- Subject has prevalent cancer.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, 543002
Min-Zhong Tang, 86+0774-3849595, gxtom@163.com
Min-Zhong Tang
- Recruiting
Zhongshan People's Hospital
Zhongshan, Guangdong, 528403
Ming-Fang Ji, 86+0760-88822698, jmftbh@sina.com
Ming-Fang Ji
About this study
Official title: Prospective Cohort Study on Epstein-Barr Virus Antibody and Cancer Risks
The goal of this prospective cohort study is to investigate the associations between Epstein-Barr Virus (EBV) antibody levels and the risk of overall and site-specific cancer types in Southern China. The main questions it aims to answer are:
Question 1: In addition to the established EBV-associated cancer types, such as lymphomas, nasopharyngeal carcinoma, and stomach cancer, whether EBV is associated with other cancer types? Question 2: What's the cancer burden attributed to EBV in Southern China?
Read the detailed description
Growing molecular evidence suggests the involvement of EBV in various cancers, however, comprehensive epidemiological evidence is still lacking. In this study, researchers conducted a population-based prospective cohort study to investigate the associations between EBV antibodies and the risk of overall and site-specific cancer types in Southern China. All the participants underwent EBV antibody tests at enrollment and were subsequently followed up annually for cancer incidence, vital status, and immigration status. The primary objective of this study was to provide prospective evidence for the role of EBV in multiple cancers, shedding light on the etiology of a broad range of common EBV-associated cancers.
- Conditions
- Cancer
- Being tested
- Diagnostic test: EBV antibody tests
- Keywords
- EBV, Prospective study, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test: EBV antibody testsOther
Participants underwent several EBV antibody tests, including VCA-IgA, EBNA1-IgA, etc.
| Study group | Role | What they receive |
|---|---|---|
| Zhongshan cohort, Guangdong, China | 30-59 years old healthy participants in Zhongshan city. Receives: Other: Diagnostic test: EBV antibody tests | |
| Wuzhou cohort, Guangxi, China | 30-69 years old healthy participants in Wuzhou city. Receives: Other: Diagnostic test: EBV antibody tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer incidence
The primary outcome of the study was the diagnosis of any type of cancer. The cancer type for each participant was defined as their initial and primary cancer diagnosis.
Measured: 10 years
Secondary outcomes (1)
All-cause mortality
The participants were followed up annually for cancer incidence, vital status and immigration status through the Cancer Registry, Death Registry, and Population Registry of local regions.
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 posted12 Jan 2024
- Study start1 Aug 2008
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, Zhongshan People's Hospital, Guangdong, China
- Responsible party
- Principal investigator, Jia wei-hua, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203314
- Sponsor's protocol ID
- EBV-PRO-001
- Acronym
- EBVCR
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to prioritize and uphold participant confidentiality and privacy, we have chosen not to provide Individual Participant Data (IPD). Our commitment is to ensure the highest level of protection for the sensitive information of our participants, aligning with ethical principles and privacy regulations. This decision is made to safeguard the well-being and privacy of the individuals involved in the study.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on Epstein-Barr Virus Antibody and Cancer Risks
- ClinicalTrials.gov ID
- NCT06203314
- Acronym / sponsor ID
- EBVCR / EBV-PRO-001
- Conditions
- Cancer
- Keywords
- EBV, Prospective study, Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, Zhongshan People's Hospital, Guangdong, China
- Study start
- 1 Aug 2008 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Jan 2024 (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 goal of this prospective cohort study is to investigate the associations between Epstein-Barr Virus (EBV) antibody levels and the risk of overall and site-specific cancer types in Southern China. The main questions it aims to answer are:
Question 1: In addition to the established EBV-associated cancer types, such as lymphomas, nasopharyngeal carcinoma, and stomach cancer, whether EBV is associated with other cancer types? Question 2: What's the cancer burden attributed to EBV in Southern China?
Detailed description
Growing molecular evidence suggests the involvement of EBV in various cancers, however, comprehensive epidemiological evidence is still lacking. In this study, researchers conducted a population-based prospective cohort study to investigate the associations between EBV antibodies and the risk of overall and site-specific cancer types in Southern China. All the participants underwent EBV antibody tests at enrollment and were subsequently followed up annually for cancer incidence, vital status, and immigration status. The primary objective of this study was to provide prospective evidence for the role of EBV in multiple cancers, shedding light on the etiology of a broad range of common EBV-associated cancers.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zhongshan cohort, Guangdong, China | – | Other: Diagnostic test: EBV antibody tests30-59 years old healthy participants in Zhongshan city. |
| Wuzhou cohort, Guangxi, China | – | Other: Diagnostic test: EBV antibody tests30-69 years old healthy participants in Wuzhou city. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30-69 years old healthy residences in Zhongshan City and Wuzhou City.
Key inclusion criteria (3 listed)
- Subject residents in Zhongshan or Wuzhou City;
- Subject has no medical record of prevalent cancer;
- Subject has psychical condition and well consciousness, and willingness to accept and cooperate with the study\'s follow-up procedures.
Key exclusion criteria (2 listed)
- Subject has heavy cardiovascular, liver, or kidney disease;
- Subject has prevalent cancer.
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 |
|---|---|---|
| Diagnostic test: EBV antibody testsParticipants underwent several EBV antibody tests, including VCA-IgA, EBNA1-IgA, etc. | Other | Wuzhou cohort, Guangxi, China, Zhongshan cohort, Guangdong, China |
Primary outcome
Cancer incidence
Time frame: 10 years
The primary outcome of the study was the diagnosis of any type of cancer. The cancer type for each participant was defined as their initial and primary cancer diagnosis.
1 secondary outcome
All-cause mortality
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No. In order to prioritize and uphold participant confidentiality and privacy, we have chosen not to provide Individual Participant Data (IPD). Our commitment is to ensure the highest level of protection for the sensitive information of our participants, aligning with ethical principles and privacy regulations. This decision is made to safeguard the well-being and privacy of the individuals involved in the study.
Related trials for Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Sun Yat-sen University at 2 sites 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei-Hua Jia (86+020-87342327, jiawh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer incidence (time frame: 10 years). 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 12 Jan 2024.