UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036283
Receipt number R000041268
Scientific Title Exploratory study of biomarkers in gallbladder cancer with GALLOP sturdy
Date of disclosure of the study information 2019/03/24
Last modified on 2019/03/24 09:51:30

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Basic information

Public title

Exploratory study of biomarkers in gallbladder cancer with GALLOP sturdy

Acronym

Exploratory study of biomarkers in gallbladder cancer with GALLOP sturdy

Scientific Title

Exploratory study of biomarkers in gallbladder cancer with GALLOP sturdy

Scientific Title:Acronym

Exploratory study of biomarkers in gallbladder cancer with GALLOP sturdy

Region

Japan


Condition

Condition

Gallbladder cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We will search for biomarkers that correlate with the prognosis of gallbladder cancer (GALLOP study UMIN000027785) from blood sampling samples.

Basic objectives2

Others

Basic objectives -Others

Search for biomarkers

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation with prognosis

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. Conditions diagnosed as gallbladder cancer and cystic duct carcinoma by diagnostic imaging before the commencement of treatment

2. Age at registration is over 20 years old

Key exclusion criteria

1. Patients who can not photograph either contrast CT or simple MRI
2. Patients judged unsuitable as subjects by the attending physician

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kei
Middle name
Last name Nakagawa

Organization

Tohoku University Hospital

Division name

Department of Surgery

Zip code

980-8574

Address

1-1, Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7205

Email

gbjimu@surg.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Kei
Middle name
Last name Nakagawa

Organization

Tohoku University Hospital

Division name

Department of Surgery

Zip code

980-8574

Address

1-1, Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7205

Homepage URL


Email

gbjimu@surg.med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research Review Board, Tohoku University School of Medicine

Address

2-1, Seiryo-machi, Aoba-ku, Sendai

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.ac.jp


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

2019 Year 03 Month 24 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

Preinitiation

Date of protocol fixation

2019 Year 02 Month 26 Day

Date of IRB

2019 Year 03 Month 05 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2022 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cohort case-control study


Management information

Registered date

2019 Year 03 Month 24 Day

Last modified on

2019 Year 03 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041268


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name