UMIN-ICDS Clinical Trial

Public title

A Study Regarding the Risk Factors for Lymph node Metastasis of Gastric Adenocarcinoma of Fundic Gland type

Acronym

RESECT-GAFG

Scientific Title

A Retrospective Multicenter Study Regarding the Risk Factors for Lymph node Metastasis of Gastric Adenocarcinoma of Fundic Gland type

Scientific Title:Acronym

RESECT-GAFG

Region

Japan

Condition

Gastric Adenocarcinoma of Fundic Gland type

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To clarify the appropriateness of local resection, including endoscopic resection, or the necessity of gastrectomy with lymph node dissection for gastric cancer of the fundic gland type.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Risk of lymph node metastasis and recurrence rate after 3 years of treatment in gastric cancer of the fundic gland type, especially submucosal invasive cancer (SM cancer).

Key secondary outcomes

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent surgical or endoscopic resection at participating institutions between January 1, 2010 and December 31, 2020, and were histologically diagnosed as gastric adenocarcinoma of fundic gland type (e.g., gastric adenocarcinoma of fundic gland type, gastric adenocarcinoma of fundic gland mucosal type) with a confirmed depth of submucosal invasion.

Key exclusion criteria

Patients with a history of cancer of the stomach or other organs within 3 years of surgery. However, the following cancers, which are considered to have almost no chance of having metastasis, are not included in the exclusion criteria
1) EP/LPM cancer of the esophagus
2) M cancer of the colon
3) Differentiated M carcinoma of the stomach less than 2 cm without ulcerative changes

Target sample size

130

Name of lead principal investigator

1st name	Yosuke
Middle name
Last name	Tsuji

Organization

The University of Tokyo Hospital

Division name

Gastroenterology

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Email

ytsujitky@g.ecc.u-tokyo.ac.jp

Name of contact person

1st name	Ryohei
Middle name
Last name	Miyata

Organization

The University of Tokyo Hospital

Division name

Gastroenterology

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL

https://gastro.m.u-tokyo.ac.jp/disclosure/

Email

mrh306@g.ecc.u-tokyo.ac.jp

Institute

Graduate School of Medicine, the University of Tokyo

Institute

Department

Personal name

Organization

Self-funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Office for Human Research Studies(OHRS) , Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

Tel

03-5841-0818

Email

ethics@m.u-tokyo.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

東京大学（東京都）、順天堂大学（東京都）、京都府立医科大学（京都府）、自治医科大学（栃木県）、日本赤十字社和歌山医療センター（和歌山県）、がん研有明病院（東京都）、千葉県がんセンター（千葉県）、関西労災病院（兵庫県）、島根大学（島根県）、県立広島病院（広島県）、四国がんセンター（愛媛県）、石川県立中央病院（石川県）、福岡大学筑紫病院（福岡県）、広島大学（広島県）、慶應義塾大学（東京都）、市立豊中病院（大阪府）、日本鋼管福山病院（広島県）、岡山大学（岡山県）、柏厚生総合病院（千葉県）、国立病院機構岡山医療センター（岡山県）、公立学校共済組合中国中央病院（広島県）、近畿大学（大阪府）、富山県立中央病院（富山県）、金沢大学（石川県）、聖隷浜松病院（静岡県）、大阪公立大学（大阪府）、静岡県立総合病院（静岡県）、日本大学（東京都）、国立国際医療研究センター国府台病院（千葉県）、福島県立医科大学（福島県）、虎の門病院（東京都）、東京慈恵会医科大学（東京都）、山口大学（山口県）、北九州市立医療センター（福岡県）、兵庫医科大学（兵庫県）、神戸市立医療センター（兵庫県）、広島市立広島市民病院（広島県）、姫路赤十字病院（兵庫県）、愛知医科大学（愛知県）、群馬大学（群馬県）

Date of disclosure of the study information

2023

Year

12

Month

28

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

2023

Year

11

Month

28

Day

Date of IRB

Anticipated trial start date

2023

Year

12

Month

25

Day

Last follow-up date

2028

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is an inter-institutional, retrospective study to investigate the risk of lymph node metastasis and recurrence rate after 3 years of treatment in patients with gastric fundic adenocarcinoma, especially submucosal invasive carcinoma (SM carcinoma), who underwent surgical or endoscopic resection at participating institutions between January 1, 2010 and December 31, 2020, and whose histological diagnosis is confirmed to have submucosal invasion at a depth.

Registered date

2023

Year

12

Month

26

Day

Last modified on

2023

Year

12

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060668