UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnosis of colorectal cancer by circulating tumor DNA
Title of the study (Brief title)	Diagnosis of colorectal cancer by circulating tumor DNA
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to address that circulating tumor DNA (p53, K-ras, B-raf, PIK3CA) and tumor DNA (p53, K-ras, B-raf, PIK3CA) in exosome before and after therapy including chemotherapy, chemoradiation therapy and surgery indicate status of colorectal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The association between prognosis and circulating tumor DNA (p53, K-ras, B-raf, PIK3CA) and tumor DNA (p53, K-ras, B-raf, PIK3CA) in exosome before and after therapy including chemotherapy, chemoradiation therapy and surgery
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	Not applicable
Gender	Male and Female
Key inclusion criteria	#1 diagnosed colorectal cancer by colonoscopy, computed tomography, and magnetic resonance imaging. #2 Age of patient is over 20 years old. #3 Informed consent can be obtained.
Key exclusion criteria	#1 Informed consent can not be obtained. #2 Doctor recognizes that patient is not suitable for this study.
Target sample size	600

Research contact person
Name of lead principal investigator	Shozo Yokoyama
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama 641-8510 Japan
TEL	073-441-0613
Email	yokoyama@wakayama-med.ac.jp

Public contact
Name of contact person	Shozo Yokoyama
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama 641-8510 Japan
TEL	073-441-0613
Homepage URL
Email	yokoyama@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University, Second Department of Surgery
Institute
Department

Funding Source
Organization	Wakayama Medical University, Second Department of Surgery
Organization
Division
Category of Funding Organization	Other
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	2017 Year 02 Month 06 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2017 Year 02 Month 03 Day
Anticipated trial start date	2017 Year 02 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study has just started.

Management information
Registered date	2017 Year 02 Month 03 Day
Last modified on	2017 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029870