UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014530 |
|---|---|
| Receipt number | R000008355 |
| Scientific Title | Search of a new tumor marker and examination of usefulness by multi-institutinal study |
| Date of disclosure of the study information | 2014/07/11 |
| Last modified on | 2021/07/06 11:49:26 |
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Basic information
Public title
Search of a new tumor marker and examination of usefulness by multi-institutinal study
Acronym
Search of a new tumor marker and examination of usefulness by multi-institutinal study
Scientific Title
Search of a new tumor marker and examination of usefulness by multi-institutinal study
Scientific Title:Acronym
Search of a new tumor marker and examination of usefulness by multi-institutinal study
Region
| Japan |
Condition
Condition
Breast cancer, Thyroid cancer, Esophageal cancer, Gastric cancer, Colon cancer, Liver cancer, Biliary cancer, Pancreatic cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness of novel tumor markers of the patients with various solid tumors using blood samples before and after surgical treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tumor markers to be analyzed are as follows. Positive rate of each tumor marker. Analysis of correlation with clinicopathological factors and various blood concentration.
-New tumor markers(cancer-specific protein and IgG antibody cancer antigen-specific antibody such as SEREX)
-Existing tumor markers(p53 antibody, CEA, SCC-Ag, CYFRA21-1, AFP, CA19-9, CA125, midkine, TPA, and IAP)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Save and analysis the sampling blood collected using a tube of 5 ml for biochemistry blood collection at the same time at the time of visit as an outpatient or admission from patients who obtained consent to this study.
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)Cases that were suspected or was diagnosed as malignant tumors clinicaly.
(2)Patients who have been informed of the diagnosis as a result of malignancy.
(3)Age to 20 years of age or older
(4)Having a sufficient judgment capability.
Key exclusion criteria
(1)Patients who are judged inappropriate for this study by the investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Shimada |
Organization
Toho University, School of Medicine
Division name
Department of Surgery
Zip code
143-8541
Address
6-11-1, Omorinishi Ota-ku, Tokyo, 143-8541 Japan
TEL
03-3762-4151
hideaki.shimada@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Shimada |
Organization
Toho University School of Medicine
Division name
Department of Surgery
Zip code
143-8541
Address
6-11-1 Omori-nishi Ota-ku Tokyo 143-8541 Japan
TEL
03-3762-4151
Homepage URL
hideaki.shimada@med.toho-u.ac.jp
Sponsor or person
Institute
Toho Univerisity
Institute
Department
Personal name
Funding Source
Organization
Toho University
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
Toho University
Address
6-11-1 Omori-nishi Otaku Tokyo Japan
Tel
03-3762-4151
hideaki.shimada@med.toho-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
| 2014 | Year | 07 | Month | 11 | 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
| 2011 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 10 | Day |
Last modified on
| 2021 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008355
