Helicobacter pylori, atrofisk gastritt og intestinal metaplasiregister og prospektiv studie
Since much is unknown about factors that lead to progression of the pre-neoplastic lesions and cancer. In addition, there is ongoing debate on the optimal surveillance intervals and techniques. To solve these important clinical questions, the establishment of a registry for a longitudinal study is planned.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Helicobacter pylori is believed to affect more than half of the world's population and is thought to affect nearly 2 million people in Hong Kong alone. It is a major cause of peptic ulcer disease and is implicated in the pathogenesis of the majority of gastric cancers. Since 1994, the World Health Organization has designated H. pylori infection as a class 1 carcinogen. Gastric cancer was the sixth commonest malignancy in Hong Kong in 2015; it was also the second commonest cause of death from cancer in Asia. It is thought that chronic inflammation of the gastric mucosa caused by H. pylori progresses to pre-neoplastic lesions, namely atrophic gastritis and intestinal metaplasia, before developing into frank dysplasia and carcinoma. Successful H. pylori eradication can lead to a rapid decrease in active inflammation, with early treatment effective in preventing the progression of disease. It is believed that atrophic gastritis may be reversible, whereas intestinal metaplasia has passed the point of no return and unlikely to have regression. National screening programmes in both Japan and Korea recommend endoscopy for all men and women over 40 years of age with several uncontrolled trials suggesting that this has led to a reduction of mortality due to gastric cancer. However, in countries with a lower incidence of gastric cancer, this population-based approach may not be cost-effective. Much is unknown about factors that lead to progression of the pre-neoplastic lesions and cancer. In addition, there is ongoing debate on the optimal surveillance intervals and techniques. To solve these important clinical questions, the establishment of a registry for a longitudinal study is planned.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Andrew Ming Yeung HO
- Telefonnummer: 26371398
- E-post: andrewho@cuhk.edu.hk
Studer Kontakt Backup
- Navn: Thomas Yuen Tung LAM
- Telefonnummer: 26370355
- E-post: thomaslam@cuhk.edu.hk
Studiesteder
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-
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Hong Kong, Hong Kong
- Rekruttering
- Prince of Wales Hospital
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Ta kontakt med:
- Thomas Yuen Tung Lam, MSc
- Telefonnummer: 26370355
- E-post: thomaslam@cuhk.edu.hk
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Hong Kong, Hong Kong
- Rekruttering
- S.H. Ho Centre for Digestive Health, Prince of Wales Hospital
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Ta kontakt med:
- Ming Yeung HO
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Inclusion Criteria
- Adults >= 18 years of age
- Written informed consent obtained
- Diagnosed with current or past H. pylori infection,
- Histologically proven atrophic gastritis (body and/or antrum of stomach), intestinal metaplasia (complete and incomplete), dysplasia (any grade) and/or gastric cancer (post-treatment)
Exclusion Criteria
- Co-morbid illness that prohibit endoscopic surveillance
- Declines for study questionnaire, biobanking of specimens and/or regular review per study protocol
Beskrivelse
Inclusion Criteria:
- Adults >= 18 years of age
- Written informed consent obtained
- Diagnosed with current or past H. pylori infection,
- Histologically proven atrophic gastritis (body and/or antrum of stomach), intestinal metaplasia (complete and incomplete), dysplasia (any grade) and/or gastric cancer (post- treatment)
Exclusion Criteria:
- Co-morbid illness that prohibit endoscopic surveillance
- Declines for study questionnaire, biobanking of specimens and/or regular review per study protocol
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical outcomes of H. pylori patients
Tidsramme: 3 years
|
Prevalence of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer |
3 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk factors of gastric pre-cancerous lesions and cancers
Tidsramme: 3 years
|
Proportion and risk factors for developing gastric pre-cancerous lesions and cancers |
3 years
|
|
Risk factors of atrophic gastirtis
Tidsramme: 3 years
|
Proportion and risk factors for developing atrophic gastritis |
3 years
|
|
Risk factors of intestinal metaplasia
Tidsramme: 3 years
|
Proportion and risk factors for developing intestinal metaplasia and progression |
3 years
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
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
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Magesykdommer
- Gastroenteritt
- Gastritt
- Gastritt, atrofisk
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Kirurgiske prosedyrer, operativ
- Minimalt invasive kirurgiske inngrep
- Diagnostiske teknikker, kirurgisk
- Diagnostiske teknikker, fordøyelsessystem
- Endoskopi
- Fordøyelsessystem kirurgiske inngrep
- Endoskopi, fordøyelsessystem
Andre studie-ID-numre
- HAR-P Protocol_v1
Plan for individuelle deltakerdata (IPD)
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