UMIN-CTR Clinical Trial

Public title

Epidemiological Survey of Non-Helicobacter pylori Helicobacter Infection in H. pylori naive patients with gastric cancer

Acronym

Epidemiological Survey of NHPH Infections in H. pylori naive GC patients

Scientific Title

Epidemiological Survey of Non-Helicobacter pylori Helicobacter Infection in H. pylori naive patients with gastric cancer

Scientific Title:Acronym

Epidemiological Survey of NHPH Infections in H. pylori naive GC patients

Region

Japan

Condition

NHPH Infections

Classification by specialty

Medicine in general	Hepato-biliary-pancreatic medicine	Infectious disease

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the NHPH infection rate, the utility of NHPH diagnostic methods, and factors contributing to NHPH infection in gastric tumor patients who have been confirmed to be non-infected with H. pylori using multiple H. pylori infection diagnostic methods.

Basic objectives2

Bio-availability

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

NHPH infection rate in gastric tumor patients confirmed to be H. pylori-free using multiple diagnostic methods

Key secondary outcomes

1. NHPH infection rates in H. pylori-naive gastric tumors in Japan by histopathological type
2. NHPH Infection rates in H. pylori-naive gastric tumors in Japan by disease type
3. Evaluation of NHPH Infection Diagnosis Using Endoscopic Aspirate from H. pylori-naive gastric tumors
4. Evaluation of Patient Background in NHPH Infections (Age, Sex, Disease, Pet Ownership History, Hormone Injection History, etc.)
5. Evaluation of abdominal symptoms in patients with NHPH infection
6. Evaluation of endoscopic findings in NHPH infection
7. Association between NHPH bacterial species and H. pylori-uninfected gastric tumors

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) H. pylori-naive gastric cancer patients who visit Oita University Hospital or one of the participating facilities and undergo an upper gastrointestinal endoscopy
(2) Patients who have given their consent to participate in this study, either verbally or in writing
(3) Patients who are over 18 years of age

Key exclusion criteria

(1) Cases positive for H. pylori
(2) Cases with a history of H. pylori eradication therapy
(3) Cases taking acid inhibory drug or antibiotics within 2 weeks prior to the endoscopy date
(4) Cases taking immunosuppressants or steroids
(5) Cases with severe complications (heart failure, renal failure, liver failure, respiratory failure)
(6) Other cases deemed inappropriate for participation in this study

Target sample size

150

Name of lead principal investigator

1st name	Mitsushige
Middle name
Last name	Sugimoto

Organization

Oita University

Division name

Research Center for GLOBAL and LOCAL Infectious Disease

Zip code

879-5593

Address

1-1 Idaigaoka, Hasama, Yufu

TEL

097-586-5401

Email

sugimo@oita-u.ac.jp

Name of contact person

1st name	Mitsushige
Middle name
Last name	Sugimoto

Organization

Oita University

Division name

Research Center for GLOBAL and LOCAL Infectious Disease

Zip code

879-5593

Address

1-1 Idaigaoka, Hasama, Yufu

TEL

097-586-5401

Homepage URL

Email

rinrikenkyu@oita-u.ac.jp

Institute

Oita University

Institute

Department

Personal name

Mitsushige Sugimoto

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Oita University Faculty of Medicine Ethics Committee

Address

1-1 Idaigaoka, Hasama, Yufu

Tel

097-586-5157

Email

rinrikenkyu@oita-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大分大学(大分県)、順天堂大学（東京都)、島根大学(島根県)、京都医療センター（京都)、京都府立医科大学(京都)、国際医療福祉大学(千葉県)、鳥取大学(鳥取)、富山大学(富山)、横浜市立大学附属病院(神奈川)、湘南鎌倉総合病院(神奈川)、国立国府台医療センター(千葉県)、虎の門病院(鳥取)、北海道対がん協会(北海道)、ふるた内科クリニック(静岡)、株式会社ミズホメディー(佐賀県)

Date of disclosure of the study information

2025

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

09

Month

25

Day

Date of IRB

Anticipated trial start date

2025

Year

11

Month

01

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1) Sample used: Gastric fluid aspirated endoscopically
2) Degree of invasiveness: Minimally invasive (gastric fluid aspiration)
3) Study design: Multicenter, prospective, non-interventional
4) Participants: Patients with gastric tumors who were H. pylori-negative, or patients who had undergone treatment for gastric tumors, who visited the outpatient department of Oita University Hospital or a collaborative research facility for this study between the date of approval by the Dean of Oita University School of Medicine and March 31, 2027.
5) Specimen Collection Facilities (14 facilities)
6) Number of Subject Cases: 150 cases
7) Methods
(1) Obtaining informed consent
(2) Clinical information gathering: General medical history interview and abdominal symptom questionnaire
(3) Upper GI endoscopy: Gastric fluid aspiration sampling and evaluation of gastric tumors and gastritis
Endoscopist assessment of gastric disease (tumors)
Presence of other gastric diseases (gastritis, erosions, atrophy, peptic ulcers, etc.) evaluated by endoscopist
Endoscopic assessment of gastritis severity (Kyoto classification of gastritis)
Endoscopic images to be sent to Oita University (Administrative Office) after case registration period ends
(4) H. pylori infection diagnosis:
1. Extracted from medical records (each facility)
Fecal antigen test, urea breath test, Pathological histological examination: Negative
No gastric mucosal atrophy, intestinal metaplasia, or inflammatory cell infiltration observed by endoscopy or pathological histological examination
2. Evaluation from gastric fluid (Infection diagnosis performed by PCR using gastric fluid collected for the study)
(5) Infection diagnosis of NHPH and H. pylori using real-time PCR with gastric fluid
Gastric fluid specimens are cryopreserved at -20 degree or below at participating research facilities and shipped to Oita University and Mizuho Medical after the case registration period ends

Registered date

2025

Year

09

Month

25

Day

Last modified on

2025

Year

09

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067699