Clinical trial NCT01264822: Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori
Official title: Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive
Keywords: Rabeprazole Sodium
Helicobacter pylori
stomach neoplasms
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-22
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitals and Clinics in Japan

Brief summary: To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori


Eligibility criteria: Inclusion criteria:

* gastric low-grade mucosa-associated lymphoid tissue (MALT) lymphoma with Helicobacter pylori positive
* The stages of MALT lymphoma are Lugano International Conference classification Stage I or II 1 and Wotherspoon grade 4 or 5

Exclusion criteria:

* With diffuse large B-cell lymphoma
* Have been treated to gastric mucosa-associated lymphoid tissue (MALT) lymphoma
* Corresponding to contraindication of each drug

Primary outcomes:
measure: Response rate of gastric low-grade MALT lymphoma by eradication of Helicobacter pylori
timeFrame: Every 3 months within the 1st year and every 6 months
measure: Transition rate to secondary therapy for eradication of Helicobacter pylori
timeFrame: Every 6 months within the 1st year and every 12 months as needed
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Hirosaki
country: Japan
state: Aomori
city: Kashiwa
country: Japan
state: Chiba
city: Matsuyama
country: Japan
state: Ehime
city: Fukuyama
country: Japan
state: Hiroshima
city: Sapporo
country: Japan
state: Hokkaido
city: Amagasaki-shi
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Hitachi
country: Japan
state: Ibaraki
city: Takamatsu
country: Japan
state: Kagawa
city: Isehara
country: Japan
state: Kanagawa
city: Sendai
country: Japan
state: Miyagi
city: Nagano-shi
country: Japan
state: Nagano
city: Suzaka
country: Japan
state: Nagano
city: Oita-shi
country: Japan
state: Oita
city: Yufu
country: Japan
state: Oita
city: Kurashiki
country: Japan
state: Okayama
city: Tsuyama
country: Japan
state: Okayama
city: Hirakata
country: Japan
state: Osaka
city: Osakasayama
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Matsue
country: Japan
state: Shimane
city: Hamamatsu
country: Japan
state: Shizuoka
city: Otawara-shi
country: Japan
state: Tochigi
city: Chuo
country: Japan
state: Tokyo
city: Itabashi
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Yamagata-shi
country: Japan
state: Yamagata
city: Ube
country: Japan
state: Yamaguchi
city: Fukuoka
country: Japan
city: Hiroshima
country: Japan
city: Kyoto
country: Japan
city: Nagasaki
country: Japan
city: Nara
country: Japan
city: Niigata
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Tottori
country: Japan
city: Toyama
country: Japan
city: Yamaguchi
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
name: Katsuya Sugizaki
role: STUDY_DIRECTOR
References: