UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013043 |
|---|---|
| Receipt number | R000015201 |
| Scientific Title | How many biopsies should we take to precisely diagnose HER2 expression of gastric cancer? |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2020/05/04 21:24:27 |
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Basic information
Public title
How many biopsies should we take to precisely diagnose HER2 expression of gastric cancer?
Acronym
How many biopsies should we take to precisely diagnose HER2 expression of gastric cancer?
Scientific Title
How many biopsies should we take to precisely diagnose HER2 expression of gastric cancer?
Scientific Title:Acronym
How many biopsies should we take to precisely diagnose HER2 expression of gastric cancer?
Region
| Japan |
Condition
Condition
Advanced gastric cancer
Classification by specialty
| Gastroenterology | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluated suitable site and number of biopsies for clinical management of gastric cancer needed chemotherapy because of various histological types and heterogeneity of HER2 expression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate the histological type and HER2 expression of six biopsy specimens.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We administer six biopsies from tumor: Two are on the surface of oral side, two are center, and two are anal side.
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) The patients who are scheduled for surgery.
2) The patients who make one's own decision to this study.
Key exclusion criteria
1) Performance Status (PS) 3 or 4.
2) The patient who has serious complications to other organs except the original illness (ASA grade more than 3).
3) The patient who cannot go off an anticoagulant therapy.
4) The patient who is judged high risk of complications on the operation.
5) The patients who does not hope for an operation or who is judged that an operation is inappropriate.
6) In addition, the patients who is judged that an operation is inappropriate by physician's own standard.
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoyuki Tominaga |
Organization
Tokyo medical university
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
aeras_nt@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoyuki Tominaga |
Organization
Tokyo medical university
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
aeras_nt@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Tokyo medical university
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Tokyo medical university
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 03 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 01 | Day |
Last modified on
| 2020 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015201
