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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012810
Receipt No. R000014956
Scientific Title Less invasive diagnostics for identification and monitoring of cancer associated mutations in blood
Date of disclosure of the study information 2014/01/10
Last modified on 2019/07/16

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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
Middle name
Last name Yusuke Mizukami
Organization Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital
Division name Division of Cancer Research
Zip code
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
Middle name
Last name Yusuke Mizukami
Organization Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital
Division name Division of Cancer Research
Zip code
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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2013 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 16 Day
Last follow-up date
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
2019 Year 07 Month 16 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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