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

NCT01824953 | Completed

• 3 other identifiers: KUH10103931010393KUH 1010393
• Study Type: observational
• Target: 3,328
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Gastric Neoplasm; Gastric Cancer; Gastric Adenoma; Gastric Atrophy; Intestinal Metaplasia

Keywords

Gastric atrophy; Helicobacter pylori; Pepsinogen; Gastric cancer; Gastric adenoma

Outcome Measures

Primary Outcomes (1)

• Newly developed gastric neoplasm

  Newly developed gastric neoplasm

  December 31, 2013

Secondary Outcomes (1)

• Degree of gastric atrophy

  December 31, 2013

Other Outcomes (1)

• Helicobacter pylori

  December 31, 2013

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (2)

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

Konkuk University Medical Center

Seoul, South Korea

Location

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.

MeSH Terms

Conditions

Stomach Neoplasms; Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastritis; Gastroenteritis

Study Officials

• Sun-Young Lee, MD

  Department of Internal Medicine, Konkuk Universtiy Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 5, 2013
• Study Start: January 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 16, 2013

Record last verified: 2013-08

Locations

KR (2)