UMIN-CTR Clinical Trial

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
Email	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
Email	hideaki.shimada@med.toho-u.ac.jp

Sponsor
Institute	Toho Univerisity
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008355