Screening av nasofaryngealt karsinom med EBV-tilknyttede biomarkører i Zhongshan City
Søker etter tidlig påvisning av biomarkører for nasofaryngeal karsinom i Zhongshan City
The study includes two cohorts: (1) a serological screening cohort; (2) a serological and EBV DNA screening cohort. All participants will be tested for EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab), with additional plasma EBV DNA testing in the latter cohort. Screening positive participants will be followed up annually.
All subjects will also be followed by record linkage to Cancer Register and Population Register.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Sample selection
- Select communities of 20,000 to 40,000 populations in Zhongshan City and Wuzhou city as the investigators' fields.
Participants recruitment
- Subjects voluntarily attend this screening study Informed consent - Informed consent forms will be collected at the recruitment. Questionnaires.
- Face-to-face interviews are conducted by well-trained investigators.
Tests and follow up
- At initial screening, all participants in both cohorts will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, P85-Ab et al. And in the serological and EBV DNA screening cohort, EBV-DNA will be tested. Consecutive EBV DNA positivity is defined as positive plasma EBV DNA results at both baseline and repeat testing approximately 4 weeks later. Based on EBNA1-IgA, VCA-IgA, participants will be stratified into high, moderate and low risk. Screening positive include P85-Ab positive, high or moderate risk of NPC or consecutive EBV DNA positive. The rest will be screening negative.
- During the initial screening and following up, people with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to the diagnostic workup for NPC. Briefly, fiberoptic endoscopy and pathological biopsy will be performed by otorhinolaryngologists.
- Screening positive people not diagnosed as nasopharyngeal carcinoma in the first year will be followed up annually.
- EBV DNA single positive people will refer to the diagnostic workup for NPC in the third year of follow up.
- The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital for further research.
- All subjects will also be followed by record linkage to Cancer Register and Population Register.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Mingfang Ji, MD
- Telefonnummer: 86-760-89880417
- E-post: jmftbh@sina.com
Studiesteder
-
-
Guangdong
-
Zhongshan, Guangdong, Kina, 528403
- Rekruttering
- Zhongshan People's Hospital
-
Ta kontakt med:
- Mingfang Ji, MD
- E-post: jmftbh@sina.com
-
Hovedetterforsker:
- Mingfang Ji, MD
-
-
Guangxi
-
Wuzhou, Guangxi, Kina, 543002
- Rekruttering
- Wuzhou Red Cross Hospital
-
Ta kontakt med:
- Yonglin Cai, MD
- E-post: cylzen@hotmail.com
-
Hovedetterforsker:
- Yonglin Cai, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
30-69 years old healthy residences in Zhongshan City and Wuzhou City.
Beskrivelse
Inclusion Criteria:
- Subject residents in Zhongshan City or Wuzhou City
- Subject has no medical record of nasopharyngeal carcinoma
- ECOG 0-2
- Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
- Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.
Exclusion Criteria:
- Subject has heavy cardiovascular, liver or kidney disease.
- Subject has contraindications to nasopharyngeal fiberoptic endoscopy.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Serological screening cohort
30-69 years old healthy participants. |
Collect blood and saliva samples from participants Detect P85-Ab, EBNA1-IgA, VCA-IgA for all participants. Screening participants with high risk or P85-Ab positive will refer to fiberoptic endoscopy and biospy Screening participants with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to fiberoptic endoscopy and biospy |
|
Serological and EBV DNA screening cohort
30-69 years old healthy participants. |
Collect blood and saliva samples from participants Detect P85-Ab, EBNA1-IgA, VCA-IgA for all participants. Screening participants with high risk or P85-Ab positive will refer to fiberoptic endoscopy and biospy Screening participants with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to fiberoptic endoscopy and biospy All participants undergo baseline EBV DNA testing. Those with positive results are invited for repeat testing approximately 4 weeks later. Consecutive positivity is defined as positive results at both tests. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity and specificity of different EBV associated biomarkers
Tidsramme: 5 years
|
To compare the sensitivity and specificity of different EBV associated biomarkers for NPC |
5 years
|
|
Positive and negative predictive values of different EBV associated biomarkers
Tidsramme: 5 years
|
To compare the positive and negative predictive values of different EBV associated biomarkers for NPC |
5 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number needed to screen to identify one nasopharyngeal carcinoma
Tidsramme: 5 years
|
To compare the number of participants needed to screen identify one nasopharyngeal carcinoma for different biomarkers |
5 years
|
|
Early diagnosis rate of nasopharyngeal carcinoma
Tidsramme: 5 years
|
To compare the early diagnosis rate of different biomarkers for nasopharyngeal carcinoma |
5 years
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The health economic benefits of different biomarkers for nasopharyngeal carcinoma
Tidsramme: 5 years
|
To explore the overall survival rate, progression free survival rate and health economic benefits of NPC screening using different biomarkers |
5 years
|
|
New screening strategy of nasopharyngeal carcinoma screening
Tidsramme: 5 years
|
Comprehensive analysis of the performance of different biomarkers and their combination in the screening of nasopharyngeal carcinoma |
5 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Mingfang Ji, MD, Zhongshan People's Hospital, Guangdong, China
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Stomatognatiske sykdommer
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer i hode og nakke
- Neoplasmer, kjertel og epitel
- Karsinom
- Otorhinolaryngologiske sykdommer
- Faryngeale neoplasmer
- Otorhinolaryngologiske neoplasmer
- Nasofaryngeale sykdommer
- Faryngeale sykdommer
- Nasofaryngeale neoplasmer
- Nasofaryngealt karsinom
- Undersøkelsesteknikker
- Prøvehåndtering
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Punkteringer
- Kirurgiske prosedyrer, operativ
- Cytologiske teknikker
- Cytodiagnose
- Diagnostiske teknikker, kirurgisk
- Biopsi
- Blodprøveinnsamling
Andre studie-ID-numre
- NPC-PRO-003
Legemiddel- og utstyrsinformasjon, studiedokumenter
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