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Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study


Phase 3
40 Years
65 Years
Open (Enrolling)
Both
Gastric Cancer, Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

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Trial Information

Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study


Inclusion Criteria:



- Sibling or offspring of patients with gastric adenocarcinoma confirmed by EGD and
biopsy

- Informed consent should be signed

Exclusion Criteria:

- Gastric cancer history

- Other malignancy within the past 5 years

- Hereditary cancer family member (HNPCC, FAP)

- Peptic ulcer history

- Peptic ulcer, esophageal cancer, gastric cancer case found at EGD

- H. pylori eradication treatment history

- Previous serious side effect to antibiotics

- Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal
failure, cardiovascular diseases

- Pregnant or nursing women

- Psychiatric disorder that would preclude compliance, alcoholics

- Refuse informed consent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Gastric cancer incidence

Outcome Description:

The incidence of gastric cancer will be compared between the two arms as the participant assigned into either LAC treatment group or placebo group regardless the final H. pylori infection status. Currently, efficacy of LAC triple therapy shows about 75-85% eradication rate of the H. pylori.

Outcome Time Frame:

6 years after last participant enrollment

Safety Issue:

No

Principal Investigator

Il Ju Choi, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea

Authority:

National Cancer Center, Korea: Institutional Review Board

Study ID:

NCCSTS04-103

NCT ID:

NCT01678027

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Gastric Cancer
  • Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
  • Family history
  • Bacterial Infections
  • Stomach Neoplasms

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