UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012810
Receipt number 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 2021/02/05 14:40:18

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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 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 or person

Institute

Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital

Institute

Department

Personal name



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

Value
https://center6.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