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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022445
Receipt No. 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

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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
Email 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
Email m-kanda@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025868

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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