UMIN-CTR Clinical Trial
| 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 (Ver. 7) |
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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 |
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| Condition | |||
| Condition | Gastric cancer | ||
| Classification by specialty |
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| 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 | |
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| Interventions/Control_8 | |
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| Interventions/Control_10 | |
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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 |
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| 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 |
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| Target sample size | 1800 | |||
| Research contact person | |||||||
| Last name of lead principal investigator |
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| 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 | |||||||
| 1st name of contact person |
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| 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 | |
| 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 |
| 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 |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Patients with gastric cancer. Healthy control. |
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| Participant flow | Collect blood samples before and after treatment. |
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| Adverse events | None. |
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| Outcome measures | Diagnostic performance. |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| 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 |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025868 |
