Helicobacter pylori, atrofisk gastrit och tarmmetaplasiregister och 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Andrew Ming Yeung HO
- Telefonnummer: 26371398
- E-post: andrewho@cuhk.edu.hk
Studera Kontakt Backup
- Namn: Thomas Yuen Tung LAM
- Telefonnummer: 26370355
- E-post: thomaslam@cuhk.edu.hk
Studieorter
-
-
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Hong Kong, Hong Kong
- Rekrytering
- Prince of Wales Hospital
-
Kontakt:
- Thomas Yuen Tung Lam, MSc
- Telefonnummer: 26370355
- E-post: thomaslam@cuhk.edu.hk
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Hong Kong, Hong Kong
- Rekrytering
- S.H. Ho Centre for Digestive Health, Prince of Wales Hospital
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Kontakt:
- Ming Yeung HO
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical outcomes of H. pylori patients
Tidsram: 3 years
|
Prevalence of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer |
3 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Risk factors of gastric pre-cancerous lesions and cancers
Tidsram: 3 years
|
Proportion and risk factors for developing gastric pre-cancerous lesions and cancers |
3 years
|
|
Risk factors of atrophic gastirtis
Tidsram: 3 years
|
Proportion and risk factors for developing atrophic gastritis |
3 years
|
|
Risk factors of intestinal metaplasia
Tidsram: 3 years
|
Proportion and risk factors for developing intestinal metaplasia and progression |
3 years
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Magsjukdomar
- Gastroenterit
- Gastrit
- Gastrit, atrofisk
- Diagnostiska tekniker och procedurer
- Diagnos
- Kirurgiska ingrepp, operativ
- Minimalt invasiva kirurgiska ingrepp
- Diagnostiska tekniker, kirurgiska
- Diagnostiska tekniker, matsmältningssystem
- Endoskopi
- Matsmältningssystemets kirurgiska procedurer
- Endoskopi, matsmältningssystem
Andra studie-ID-nummer
- HAR-P Protocol_v1
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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Studerar en amerikansk FDA-reglerad produktprodukt
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