UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029927 |
|---|---|
| Receipt number | R000033991 |
| Scientific Title | The study of treatment guidelines of gastric carcinoid with type A chronic atrophic gastritis. |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2022/11/11 08:17:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The study of treatment guidelines of gastric carcinoid with type A chronic atrophic gastritis.
Acronym
Treatment guidelines of gastric carcinoid
Scientific Title
The study of treatment guidelines of gastric carcinoid with type A chronic atrophic gastritis.
Scientific Title:Acronym
Treatment guidelines of gastric carcinoid
Region
| Japan |
Condition
Condition
Gastric carcinoid with type A gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Establish appropriate treatment guideline and clarify the long-term prognosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Long-term prognosis according to the treatment method
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) positive anti-parietal cell antibody or 2) presence of fundic gland atrophy and hyperplasia of ECL cells or 3) evidence of hypergastrinemia (>450pg/ml)
Key exclusion criteria
no evidence of multiple endocrine neoplasia (MEN)-Zollinger-ellison syndrome
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Haruma |
Organization
Kawasaki Medical School
Division name
General Internal Medicine 2
Zip code
7008505
Address
2-6-1, Nakasannge, Kita-ku, Okayama
TEL
086-225-2111
kharuma@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Tomoari |
| Middle name | |
| Last name | Kamada |
Organization
Kawasaki Medical School
Division name
Dept. of Health Care Medicine
Zip code
7008505
Address
2-6-1, Nakasannge, Kita-ku, Okayama
TEL
086-225-2111
Homepage URL
tkamada@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan Gastroenterological Endoscopy Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
2-6-1, Nakasannge, Kita-ku, Okayama
Tel
086-225-2111
tkamada@med.kawasaki-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://m.kawasaki-m.ac.jp/kenkyu/rinri/document/kadai/2017/2941.pdf
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
190
Results
Results: None of the patients showed local recurrence or distant metastasis. As the results of long-term follow-up for 25 years (median 8 years), RFS and DSS were 93.2% (123/132), 100% (132/132, respectively.
Results date posted
| 2020 | Year | 05 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
GNETs with AIG in a multicenter Japanese registry.
Participant flow
Between 1991 and 2019, 190 patients with diagnosis of GNETs confirmed histologically were recruited from 40 institutions in Japan.
Adverse events
none
Outcome measures
Patients underwent endoscopic surveillance (n= 51), endoscopic resection (n= 80), and surgical resection (n= 18). None of the patients showed local recurrence or distant metastasis. As the results of long-term follow-up for 25 years (median 8 years), RFS and DSS were 93.2% (123/132), 100% (132/132, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 11 | Month | 10 | Day |
Last modified on
| 2022 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033991
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
