UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012893
Receipt number R000015065
Scientific Title Less invasive diagnostics for cancer using hair follicle
Date of disclosure of the study information 2014/01/18
Last modified on 2017/07/20 09:21:17

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Basic information

Public title

Less invasive diagnostics for cancer using hair follicle

Acronym

A new test for cancer examines hair follicles

Scientific Title

Less invasive diagnostics for cancer using hair follicle

Scientific Title:Acronym

A new test for cancer examines hair follicles

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 cancer screening by gene expression profile in the hair follicle

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Comparison of the gene expression profile in hair follicle between cancer patients and healthy volunteer

Key secondary outcomes

Comparison of the gene expression profile in hair follicle among the cancer patients with various stages and organs


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

170


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 or person

Institute

Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Shonan Kamakura General Hospital
Chiba Tokushukai Hospital
Teine Keijinkai 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 18 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


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

Nothing special


Management information

Registered date

2014 Year 01 Month 18 Day

Last modified on

2017 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015065


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name