UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018638 |
|---|---|
| Receipt number | R000021211 |
| Scientific Title | The observational study on clinical application of the storomal forming protein for tumor stromal marker |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2020/02/13 18:30:30 |
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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
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
y-mizu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine.
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021211
