Long-term Follow-up Prognosis of Atrophic Gastritis After 3 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun-Young Lee, Konkuk University Medical Center
ClinicalTrials.gov Identifier:
NCT01824953
First received: March 28, 2013
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

Serum pepsinogen (PG) levels are considered reliable markers for progression of atrophic gastritis with a stepwise reduction in the serum PG I level or PG I/II ratio. A combination of serum PG levels and Helicobacter pylori serology are used as a biomarker strategy for detection of individuals at increased risk of gastric neoplasm based on Correa's hypothesis. The investigators aimed to uncover whether this combination method could predict the risk of gastric neoplasms and the progression of chronic atrophic gastritis after 3 years. All the participants will be followed for an expected average of 3 years.


Condition
Gastric Neoplasm
Gastric Cancer
Gastric Adenoma
Gastric Atrophy
Intestinal Metaplasia

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Significance of Helicobacter Pylori Infection and Pepsinogen Levels on the Prognosis of Atrophic Gastritis - Observational Study

Resource links provided by NLM:


Further study details as provided by Konkuk University Medical Center:

Primary Outcome Measures:
  • Newly developed gastric neoplasm [ Time Frame: December 31, 2013 ] [ Designated as safety issue: No ]
    Newly developed gastric neoplasm


Secondary Outcome Measures:
  • Degree of gastric atrophy [ Time Frame: December 31, 2013 ] [ Designated as safety issue: No ]
    Degree of gastric atrophy measured by serum pepsinogen I and II levels


Other Outcome Measures:
  • Helicobacter pylori [ Time Frame: December 31, 2013 ] [ Designated as safety issue: No ]
    Presence of Helicobacter pylori infection


Biospecimen Retention:   Samples Without DNA

Serum for Helicobacter pylori antibody and pepsinogen levels Gastric biopsy for the diagnosis of intestinal metaplasia, atrophy, inflammatory cells, Helicobacter pylori, and the presence of gastric neoplasm if any.


Enrollment: 3328
Study Start Date: January 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
atrophy-/Hp- group
Subjects without Helicobacter pylori infection and without atrophy
atrophy-/Hp+
Subjects with Helicobacter pylori infection and without atrophy
atrophy+/Hp+
Subjects with Helicobacter pylori infection and with atrophy
atrophy+/Hp-
Subjects without Helicobacter pylori infection and with atrophy

Detailed Description:

According to the Correa's hypothesis, the combination method using serum pepsinogen levels and serum Helicobacter pylori antibody would predict the risk and cell type of gastric neoplasm. However, in endemic regions of H. pylori infection such as in East Asian countries (Korea, Japan, and China), most of the aged population are have current or had past H. pylori infection. Therefore, in this study, we are going to uncover whether the risk of gastric neoplasm is significantly higher in the atrophy(+)/H. pylori(-) group followed by atrophy(+)/H. pylori(+), atrophy(-)/H. pylori(+), and atrophy(-)/H. pylori(-) groups. In addition, we are going to investigate whether those slow-growing gastric neoplasms such as differentiated gastric cancers with Lauren's intestinal type and gastric adenoma are more commonly developed in atrophy group following the Correa's hypothesis, whereas rapid-growing gastric neoplasms such as poorly-cohesive carcinoma or undifferentiated gastric cancers with Lauren's diffuse type are more commonly developed in the subjects without atrophy. Taken as a whole, our study result will provide an evidence whether this biomarker strategy are useful for the detection of individuals at increased risk of gastric neoplasm.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Asymptomatic Korean adults who underwent serum PG tests, H. pylori serology, and upper gastrointestinal endoscopy on the same day at our center.

Criteria

Inclusion Criteria:

  • Korean adults older than 18 year-old
  • Subjects who agreed on serum pepsinogen tests, H. pylori serology, and upper gastrointestinal endoscopy on the same day

Exclusion Criteria:

  • Subjects who had past history of gastric surgery
  • Abnormal endoscopic or laboratory finding that require further treatment
  • Any evidence of malignancy other than gastric neoplasm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824953

Locations
Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Konkuk University Medical Center
Investigators
Principal Investigator: Sun-Young Lee, MD Department of Internal Medicine, Konkuk Universtiy Medical Center
  More Information

No publications provided

Responsible Party: Sun-Young Lee, Associate professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT01824953     History of Changes
Other Study ID Numbers: KUH1010393, 1010393, KUH 1010393
Study First Received: March 28, 2013
Last Updated: August 15, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Konkuk University Medical Center:
Gastric atrophy
Helicobacter pylori
Pepsinogen
Gastric cancer
Gastric adenoma

Additional relevant MeSH terms:
Adenoma
Atrophy
Gastritis, Atrophic
Metaplasia
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastritis
Gastroenteritis
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pathologic Processes
Pathological Conditions, Anatomical
Stomach Diseases

ClinicalTrials.gov processed this record on October 29, 2014