UMIN-CTR Clinical Trial

Basic information
Public title	The observational study on clinical application of the storomal forming protein for tumor stromal marker
Acronym	Tumor stromal marker observational study
Scientific Title	The observational study on clinical application of the storomal forming protein for tumor stromal marker
Scientific Title:Acronym	Tumor stromal marker observational study
Region	Japan

Condition
Condition	pancretic cancer,pancreatic beneign tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Clinical application of stromal forming protein in human blood serum
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Research about function of stromal forming protein in human blood serum or stromal telar
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	The patient who was diagnosed as a pancreatic tumor aged 20 and over and surgery or a chemotherapy is planned.
Key exclusion criteria	(A)The patient with an acute abdomen (B)The patient with critical acute inflammation (C)The patient under pregnancy (D)The patient whose general state is very poor (E)The patient who has participated in this examination (F)The patient whom doctors judged as unsuitable
Target sample size	100

Research contact person
Name of lead principal investigator	1st name HIROOKA Middle name Last name YOSHIKI
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	4668560
Address	65 Tsuruma-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL	052-741-2111
Email	hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name YASUYUKI Middle name Last name MIZUTANI
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	4668560
Address	65 Tsuruma-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL	052-741-2111
Homepage URL
Email	y-mizu@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine. Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine. Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nagoya University Graduate School of Medicine
Address	65 Tsuruma-cho, Showa-ku, Nagoya, 466-8550, Japan
Tel	052-741-2111
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	2015 Year 10 Month 01 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	Preinitiation
Date of protocol fixation	2015 Year 08 Month 11 Day
Date of IRB	2015 Year 10 Month 29 Day
Anticipated trial start date	2015 Year 10 Month 30 Day
Last follow-up date	2022 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Clinical observation trial Objective; All Patients who suit this trial's criterion of selecting between October 2015- October 2022. Measurements; We measure the protein in human serum which we have revealed specifically in the stroma by the protein detecting methods, such as ELIZA. We investigate protein specific to cancer stroma to become a tumor marker,especially clinical application is possible.

Management information
Registered date	2015 Year 08 Month 11 Day
Last modified on	2020 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021211