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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033808
Receipt No. R000038565
Scientific Title Usefulness of the quantification of long non-coding RNA H19 in the plasma of the patients with gastric cancer
Date of disclosure of the study information 2018/08/20
Last modified on 2018/08/20

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Basic information
Public title Usefulness of the quantification of long non-coding RNA H19 in the plasma of the patients with gastric cancer
Acronym Prospective observational study on long non-coding RNA H19 in gastric cancer plasma
Scientific Title Usefulness of the quantification of long non-coding RNA H19 in the plasma of the patients with gastric cancer
Scientific Title:Acronym Prospective observational study on long non-coding RNA H19 in gastric cancer plasma
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify whether the quantification of long non-cording RNA H19 in the palsma of the patients with gastric cancer can predict tumor progression or long-term survival outcomes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Confirm whether the expression level of H19 gene increases with the progress of cancer stage
Key secondary outcomes Confirm increase and decrease in expression level of H19 gene before and after surgery

Compare with usefulness of tumor markers such as CEA and CA 19-9

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) Histologically proven gastric cancer
2) With written informed consent before surgery
3) Preoperatively diagnosed as Stage I-IV
Key exclusion criteria patients without preoperative informed consent
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Watanabe
Organization Kitasato University School of Medicine
Division name Department of Surgery
Zip code
Address 1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Email gekaw@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Harada
Organization Kitasato University School of Medicine
Division name Department of Surgery
Zip code
Address 1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Homepage URL
Email dm16025@st.kitasato-u.ac.jp

Sponsor
Institute Department of Surgery, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Department of Surgery, Kitasato University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 08 Month 20 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2018 Year 08 Month 20 Day
Last modified on
2018 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038565

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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