UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of rapid detection methods on cancer-related components in blood and body fluid samples from cancer patients
Title of the study (Brief title)	Development of rapid detection methods on cancer-related components in blood and body fluid samples from cancer patients
Region	Japan

Condition
Condition	Cancer (positive control) and benign diseases (negative control)
Classification by specialty	Medicine in general Surgery in general
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Development of rapid detection methods on cancer-related components in blood and body fluid samples from patients with cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quantitative detection of cancer-related components in blood and body fluid samples from patients with cancer and benign disease.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Patients with histologically proven cancer and benign disease patients without cancer who are treated in Showa University Koto Toyosu Hospital and Ryukyu University Hospital since 2015. (2) Clinical solitary tumor (cancer patients) (3) No prior treatment (4) Age 20-80 years (5) Eastern Cooperative Oncology Group performance status 0 or 1 (6) Sufficient organ function (7) Written informed consent
Key exclusion criteria	(1) Synchronous or metachronous malignancy (2) Pregnant or breastfeeding women
Target sample size	500

Research contact person
Name of lead principal investigator	Hiroaki Ito, MD, PhD
Organization	Showa University Koto-Toyosu Hospital
Division name	Digestive Disease Center
Address	5-1-38 Toyosu, Koto-ku, Tokyo 135-8577 Japan
TEL	03-6204-6000
Email	h.ito@med.showa-u.ac.jp

Public contact
Name of contact person	Hiroaki Ito, MD, PhD
Organization	Showa University Koto-Toyosu Hospital
Division name	Digestive Disease Center
Address	5-1-38 Toyosu, Koto-ku, Tokyo 135-8577 Japan
TEL	03-6204-6000
Homepage URL
Email	h.ito@med.showa-u.ac.jp

Sponsor
Institute	Digestive Disease Center, Showa University Koto-Toyosu Hospital
Institute
Department

Funding Source
Organization	Digestive Disease Center, Showa University Koto-Toyosu Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 12 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 17 Day
Anticipated trial start date	2015 Year 12 Month 17 Day
Last follow-up date	2016 Year 02 Month 28 Day
Date of closure to data entry	2016 Year 02 Month 28 Day
Date trial data considered complete	2016 Year 02 Month 28 Day
Date analysis concluded	2016 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective study. Blind blood serum samples from patients with histologically proven cancer and benign disease patients without cancer who are treated in Showa University Koto Toyosu Hospital and Ryukyu University Hospital since 2015 will be prospectively analyzed by using the bio-chip (Proteo). We will detect a surface-enhanced Raman scattering and autofluorescence to distinguish cancer patients from non-cancer patients.

Management information
Registered date	2015 Year 12 Month 17 Day
Last modified on	2017 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023378