UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047115 |
|---|---|
| Receipt number | R000053743 |
| Scientific Title | A single-institutional retrospective observational study on evaluation of HER2 expression by immunohistochemical staining in unresectable advanced gastric cancer |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/09/08 10:19:10 |
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Basic information
Public title
A single-institutional retrospective observational study on evaluation of HER2 expression by immunohistochemical staining in unresectable advanced gastric cancer
Acronym
HER_WEEKEND study
Scientific Title
A single-institutional retrospective observational study on evaluation of HER2 expression by immunohistochemical staining in unresectable advanced gastric cancer
Scientific Title:Acronym
HER_WEEKEND study
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is a single institutional retrospective observational study of HER2 evaluation by immunohistochemistry (HER2_IHC) measured in clinical practice for unresectable advanced/recurrent gastric cancer by sample type (biopsy or surgical specimen) and HER2 test submission date (Weekday or Weekend, including public holidays and the day before).
Basic objectives2
Others
Basic objectives -Others
The difference in the HER2_IHC expression level and the effect of formalin fixation time will be investigated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HER2 positive rate: sample type (biopsy / surgical specimen) and test submission date (Weekday / Weekend)
Key secondary outcomes
1. HER2 positive rate among all study subjects
2. Comparison of HER2 positive rate by sample collection date (WD/WE) for different sample types (biopsy/surgical specimen)
3. Comparison of formalin fixation time by sample collection date (WD/WE)
4. Comparison of formalin fixation time by sample type (biopsy/surgical specimen)
5. Comparison of formalin fixation time in the sample type (biopsy/surgical specimen) according to the sample collection date (WD/WE)
6. Comparison of formalin fixation time and HER2 expression rate by sample type (biopsy/surgical specimen)
7. The difference in formalin fixation time (all population/sample type/sample collection date)
8. Comparison of treatment results by HER2 status (positive/negative) (overall survival from the start of chemotherapy, duration of response to trastuzumab combination therapy, and response rate)
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. Cases in which HER2_IHC was performed when performing chemotherapy for unresectable advanced/recurrent gastric cancer.
2. Cases in which clinicopathological information can be collected at the time of HER2_IHC measurement.
Key exclusion criteria
1. Cases in which HER2_IHC has not been performed.
2. Patients judged by the principal investigator to be inappropriate as research subjects.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Nakamura |
Organization
Sapporo City General Hospital
Division name
Department of Gastroenterology
Zip code
060-8604
Address
1-1, Kita-11-jo, Nishi-13-chome, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-726-2211
michio.nakamura@doc.city.sapporo.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Nakamura |
Organization
Sapporo City General Hospital
Division name
Department of Gastroenterology
Zip code
060-8604
Address
1-1, Kita-11-jo, Nishi-13-chome, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-726-2211
Homepage URL
michio.nakamura@doc.city.sapporo.jp
Sponsor or person
Institute
Sapporo City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Sapporo City General Hospital
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
Sapporo City General Hospital Ethics Committee
Address
1-1, Kita-11-jo, Nishi-13-chome, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-726-2211
takahiro_suzuki@city.sapporo.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
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
177
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
Main results already published
Date of protocol fixation
| 2022 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study using only electric medical information, and there is no invasion or intervention to the study subjects.
Management information
Registered date
| 2022 | Year | 03 | Month | 08 | Day |
Last modified on
| 2023 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053743
