UMIN-CTR Clinical Trial

Basic information
Public title	Less invasive diagnostics for identification and monitoring of cancer associated mutations in blood
Acronym	Liquid biopsy: monitoring cancer-genetics in the blood
Scientific Title	Less invasive diagnostics for identification and monitoring of cancer associated mutations in blood
Scientific Title:Acronym	Liquid biopsy: monitoring cancer-genetics in the blood
Region	Japan

Condition
Condition	Patients suffering from tumors such as colorectal, lung and pancreatic cancer and precancerous disease
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Breast surgery Laboratory medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To examine the efficacy and validity of the quantitative detection of tumor-associated mutations in plasma DNA.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Quantitative detection and monitoring of genetic mutations in tumor-associated genes, such as oncogenic KRAS, in circulating plasma DNA.
Key secondary outcomes	Comparison of the oncogenetic mutations in plasma DNA with those in corresponding tumor tissue DNA.

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	Patients with benign and malignant tumor and healthy volunteers Patients with written informed consent
Key exclusion criteria	None
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Mizukami
Organization	Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital
Division name	Division of Cancer Research
Zip code	065-0033
Address	14-3-1, Kita 33-jo Higashi, Higashi-ku, Sapporo, Hokkaido
TEL	011-722-1110
Email	ymizu_ccbr@tohtoku.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Mizukami
Organization	Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital
Division name	Division of Cancer Research
Zip code	065-0033
Address	14-3-1, Kita 33-jo Higashi, Higashi-ku, Sapporo, Hokkaido
TEL	011-722-1110
Homepage URL
Email	ymizu_ccbr@tohtoku.jp

Sponsor
Institute	Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital
Institute
Department

Funding Source
Organization	Pancreatic Research Foundation of Japan
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Shonan Kamakura General Hospital Chiba Tokushukai Hospital Teine Keijinkai Hospital Shibetsu City Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Mirai Iryo Research Center Inc
Address	1-8-7 Koji-machi Chiyoda-ku Tokyo
Tel	03-3263-4801
Email	mirai-ec1@mirai-iryo.com

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	医療法人 徳洲会 札幌東徳洲会病院付属臨床研究センター（北海道）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 10 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	Completed
Date of protocol fixation	2013 Year 10 Month 04 Day
Date of IRB	2013 Year 10 Month 03 Day
Anticipated trial start date	2013 Year 10 Month 16 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective study

Management information
Registered date	2014 Year 01 Month 10 Day
Last modified on	2021 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014956