UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022445 |
|---|---|
| Receipt number | R000025868 |
| Scientific Title | The diagnostic performance of novel serum biomarkers for gastric cancer; a prospective observational study |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/05/28 09:09:16 |
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Basic information
Public title
The diagnostic performance of novel serum biomarkers for gastric cancer; a prospective observational study
Acronym
The diagnostic performance of novel serum biomarkers for gastric cancer; a prospective observational study
Scientific Title
The diagnostic performance of novel serum biomarkers for gastric cancer; a prospective observational study
Scientific Title:Acronym
The diagnostic performance of novel serum biomarkers for gastric cancer; a 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 prospective observational study was to validate the diagnostic performance of serum ANOS1, MAGE-D2 and DPYSL3, and determine their optimal cutoff values.
Basic objectives2
Others
Basic objectives -Others
To validate the diagnostic performance of serum ANOS1, MAGE-D2 and DPYSL3, and determine their optimal cutoff values.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum levels of candidate biomarkers before treatment
Key secondary outcomes
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
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
1. Patients with histologically confirmed adenocarcinoma of the stomach, or healthy volunteers (individuals who are confirmed to have no malignancies by upper gastrointestinal endoscopy and CT scan) for a control group
2. Aged 20 years or older
3. No prior treatment (as for patients with gastric cancer)
4. Written informed consent before initiation of study related procedures
Key exclusion criteria
1. Presence of other malignancies
2. Any condition that makes the patient unsuitable for inclusion in the study according to the investigators
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kodera |
Organization
Nagoya University Hospital
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 | Mitsuro |
| Middle name | |
| Last name | Kanda |
Organization
Nagoya University Hospital
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
m-kanda@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
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
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
330
Results
A novel serum biomarker for gastric cancer has been proposed.
Results date posted
| 2019 | Year | 05 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with gastric cancer.
Healthy control.
Participant flow
Collect blood samples before and after treatment.
Adverse events
None.
Outcome measures
Diagnostic performance.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation parameters; Serum levels of candidate biomarkers 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
| 2016 | Year | 05 | Month | 25 | Day |
Last modified on
| 2019 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025868
