UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053203 |
|---|---|
| Receipt number | R000060722 |
| Scientific Title | The validation study of diagnostic performance of a novel serum biomarker for gastric cancer measured by ELISA; a multi-institutional prospective observational study |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2023/12/22 21:04:18 |
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Basic information
Public title
The validation study of diagnostic performance of a novel serum biomarker for gastric cancer measured by ELISA; a multi-institutional prospective observational study
Acronym
The validation study of diagnostic performance of a novel serum biomarker for gastric cancer measured by ELISA; a prospective observational study
Scientific Title
The validation study of diagnostic performance of a novel serum biomarker for gastric cancer measured by ELISA; a multi-institutional prospective observational study
Scientific Title:Acronym
The validation study of diagnostic performance of a novel serum biomarker for gastric cancer measured by ELISA; a multi-institutional prospective observational study
Region
| Japan | Asia(except Japan) |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this multi-institutional prospective observational study was to validate the diagnostic significance of serum SDF4 levels in gastric cancer patients measured by ELISA.
Basic objectives2
Others
Basic objectives -Others
To validate the diagnostic performance of serum SDF4, and determine their optimal cutoff values.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum SDF4 levels before treatment
Key secondary outcomes
Changes in serum SDF4 levels after treatment, comparison with the healthy control group, correlations with tumor factors, existing tumor markers, inflammatory factors and postoperative 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･Patients with histologically confirmed adenocarcinoma of the stomach, or healthy volunteers (individuals who received health care examination through department of family medicine and are confirmed to have no malignancies by upper GI endoscopy and abdominal CT scan) for a control group
･Aged over 20 years old
･No prior treatment (as for patients with gastric cancer)
･Written informed consent before initiation of study related procedures
Key exclusion criteria
･Presence of other malignancies
･Any condition that makes the patient unsuitable for inclusion in the study according to the investigators
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2233
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Shinozuka |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2249
Homepage URL
tshinozuka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Funding from the Center for Advanced Medicine and Clinical Research at Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
1. Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine
2. Department of Family Medicine, Seoul National University Hospital, Seoul National University College of Medicine
3. Department of Surgery, Seoul National University Bundang Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Ethics Review Committee
Address
65 Tsurumai-cho,Showa-ku,Nagoya
Tel
052-744-2479
ethics@med.nagoya-u.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
| 2023 | Year | 12 | Month | 25 | 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
| 2023 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation parameters; Serum SDF4 levels before treatment, changes in serum levels of candidate biomarkers after treatment, comparison with the healthy control group, correlations with tumor factors, existing tumor markers, inflammatory factors and postoperative outcomes
Management information
Registered date
| 2023 | Year | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060722
| Research Plan | |
|---|---|
| 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 |
