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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043631
Receipt No. R000049803
Scientific Title Exploring the role of serum Leucine-Rich alfa-2-Glycoprotein as a predictor of gastrointestinal cancer detection, progression and therapeutic effects
Date of disclosure of the study information 2021/03/19
Last modified on 2021/03/15

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Basic information
Public title Exploring the Role of LRG in Gastrointestinal Cancer Care
Acronym Exploring the Role of LRG in Gastrointestinal Cancer Care
Scientific Title Exploring the role of serum Leucine-Rich alfa-2-Glycoprotein as a predictor of gastrointestinal cancer detection, progression and therapeutic effects
Scientific Title:Acronym Exploring the role of serum Leucine-Rich alfa-2-Glycoprotein as a predictor of gastrointestinal cancer detection, progression and therapeutic effects
Region
Japan

Condition
Condition Gastrointestinal cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate whether LRG is useful in determining diagnosis and treatment strategies and predicting treatment effects in gastrointestinal cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation of LRG values with disease stage or treatment response
Key secondary 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 who will receive an examination and treatment for gastrointestinal cancer or suspected gastrointestinal cancer at Nagoya University Hospital.
Key exclusion criteria Patients under 20 years of age
Patients with active infectious disease at the time of enrollment
Patients who have been diagnosed with autoimmune diseases and are undergoing treatment.
Patients who are deemed inappropriate by the investigator.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Furune
Organization Nagoya University Hospital
Division name Department of Clinical Oncology and Chemotherapy
Zip code 466-0065
Address 65 Tsurumai-cho Showa-ku,Nagoya, Aichi
TEL 0527442172
Email s-furune@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Furune
Organization Nagoya University Hospital
Division name Department of Clinical Oncology and Chemotherapy
Zip code 466-0065
Address 65 Tsurumai-cho Showa-ku,Nagoya, Aichi
TEL 0527441902
Homepage URL
Email s-furune@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya University
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 Nagoya University Hospital ethics committee
Address 65 Tsurumai-cho Showa-ku,Nagoya, Aichi
Tel 0527412111
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
2021 Year 03 Month 19 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
2021 Year 02 Month 03 Day
Date of IRB
2021 Year 02 Month 03 Day
Anticipated trial start date
2021 Year 02 Month 03 Day
Last follow-up date
2030 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Measuring LRG before and after therapeutic intervention in gastrointestinal cancer.

Management information
Registered date
2021 Year 03 Month 16 Day
Last modified on
2021 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049803

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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