UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021359 |
|---|---|
| Receipt number | R000024631 |
| Scientific Title | Detection of the pulmonary nodular lesion using computed tomography after gastric cancer resection |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2016/03/06 12:28:07 |
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Basic information
Public title
Detection of the pulmonary nodular lesion using computed tomography after gastric cancer resection
Acronym
Detection of the pulmonary nodular lesion using computed tomography after gastric cancer resection
Scientific Title
Detection of the pulmonary nodular lesion using computed tomography after gastric cancer resection
Scientific Title:Acronym
Detection of the pulmonary nodular lesion using computed tomography after gastric cancer resection
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effectiveness to detect of the pulmonary nodular lesion using computed tomography after gastric cancer resection
Basic objectives2
Others
Basic objectives -Others
incidence of pneumonia, incidence of swelling lymph nodes in the mediastinum
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of the pulmonary nodular lesion using computed tomography after gastric cancer resection
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Histologically proven gastric adenocarcinoma.
(2) Clinical stage I-III according to the 14th edition of Japanese Classification of Gastric Carcinoma (3rd English edition).
(3) Performed postoperative surveillance using chest computed tomography,and checked by the radiologist
(4) No synchronous or metachronous malignancies.
(5) Written informed consent.
Key exclusion criteria
Considered inadequate for inclusion in this trial by the doctor
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2111
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chie Tanaka |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2249
Homepage URL
chtanaka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In patients fulfilling the criteria between May 1, 2016 and November 30, 2019.
Preoperative assessment;
Imaging
Intra- and postoperative assessment;
(1) Past history
(2) Intraoperative findings
(3) Pathological findings
(4) Intraoperative complications
(5) Postoperative complications
(6) Postoperative chest computed tomography
(7) Treatment for the pulmonary lesions
(8) Day of recurrence and death
Management information
Registered date
| 2016 | Year | 03 | Month | 05 | Day |
Last modified on
| 2016 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024631
