UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045382 |
|---|---|
| Receipt number | R000051821 |
| Scientific Title | A retrospective observational study of risk factors for postoperative recurrence in early gastric cancer |
| Date of disclosure of the study information | 2021/09/06 |
| Last modified on | 2024/04/02 13:13:17 |
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Basic information
Public title
A retrospective observational study of risk factors for postoperative recurrence in early gastric cancer
Acronym
A retrospective observational study of risk factors for postoperative recurrence in early gastric cancer
Scientific Title
A retrospective observational study of risk factors for postoperative recurrence in early gastric cancer
Scientific Title:Acronym
A retrospective observational study of risk factors for postoperative recurrence in early gastric cancer
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate the long-term postoperative prognosis of patients with early gastric cancer and identify groups at high risk of recurrence for possible adjuvant chemotherapy
Basic objectives2
Others
Basic objectives -Others
Investigate the long-term postoperative prognosis of patients with early gastric cancer and identify groups at high risk of recurrence for possible adjuvant chemotherapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease-specific survival
Key secondary outcomes
(1)Overall postoperative survival
(2)Recurrence-free survival
(3)Incidence of postoperative complications
(4)Histopathological factors
(5)Recurrence pattern
(6)With or without postoperative chemotherapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent radical resection for gastric cancer at the Second Department of Surgery, Wakayama Medical University between January 1999 and December 2013, and who meet the following criteria.
1) Depth of tumor is up to SM (T1b)
2) Do not have multiple gastric cancer
3) The patient's age is 20 years or older
4) No history of preoperative chemotherapy
5) No history of gastrectomy
Key exclusion criteria
1) Possibility of tumor remnant
2) General anesthesia is not possible such as interstitial pneumonia, pulmonary fibrosis, severe respiratory infection
3) Patients with multiple malignant diseases
Target sample size
1001
Research contact person
Name of lead principal investigator
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Ojima |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
TEL
0734472300
tojima@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | AKIHIRO |
| Middle name | |
| Last name | TAKEUCHI |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
TEL
0734472300
Homepage URL
a-take@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
0734472300
wa-rinri@wakayama-med.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
和歌山県立医科大学
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S1091255X23005978?via%3Dihub
Publication of results
Unpublished
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S1091255X23005978?via%3Dihub
Number of participants that the trial has enrolled
1001
Results
Long-term prognosis of patients with EGC with lymph node metastasis is good, but venous invasion is associated with a higher risk of recurrence. Selective application of postoperative adjuvant chemotherapy for pT1N + v + gastric cancer may efficiently improve prognosis among patients with EGC.
Results date posted
| 2024 | Year | 04 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with pT1N1 or higher among those who underwent radical gastric cancer surgery
Participant flow
Retrospective review of surgical cases
Adverse events
no special notes
Outcome measures
Disease-specific 5-year survival rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
To analyze the risk of recurrence and poor prognostic factors after surgery for early stage gastric cancer
Management information
Registered date
| 2021 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051821
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
