UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012940
Receipt number R000015138
Scientific Title Gene mutation analysis such as FGF signaling in gastrointesitinal cancer
Date of disclosure of the study information 2014/01/24
Last modified on 2022/08/01 10:11:59

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Gene mutation analysis such as FGF signaling in gastrointesitinal cancer

Acronym

Gene mutation analysis such as FGF signaling in gastrointesitinal cancer

Scientific Title

Gene mutation analysis such as FGF signaling in gastrointesitinal cancer

Scientific Title:Acronym

Gene mutation analysis such as FGF signaling in gastrointesitinal cancer

Region

Japan


Condition

Condition

Cancer of digestive organs

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To analyse gene mutation such as Fibroblast Growth Factor (FGF) signaling in cancer of digestive organs.

Basic objectives2

Others

Basic objectives -Others

Analysisi of gene mutation and location in cancer of digestive organs.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence and location of gene mutation such as FGF-FGFR signaling in cancer of digestive organs.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with cancer in digestive organs (esophageal, gastric , biliary, pancreatic) whose paraffin-embedded samples by biopsy, endoscopic resection or surgery were obtained at St Marianna University School of Medicine Hospital .

Key exclusion criteria

None

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name TAKAKO NAKAJIMA

Organization

St. Marianna University School of Medicine

Division name

Department of Clinical Oncology

Zip code


Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa

TEL

0449778111

Email

tnakajima@marianna-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name TAKAKO NAKAJIMA

Organization

St. Marianna University School of Medicine

Division name

Department of Clinical Oncology

Zip code


Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa

TEL

0449778111

Homepage URL


Email

tnakajima@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

St. Marianna University School of Medicine

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kinki University School of Medicine, Department of Genome Biology

Name of secondary funder(s)

Kinki University School of Medicine, Department of Genome Biology


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



Other administrative information

Date of disclosure of the study information

2014 Year 01 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

Terminated

Date of protocol fixation

2013 Year 06 Month 11 Day

Date of IRB

2013 Year 10 Month 10 Day

Anticipated trial start date

2014 Year 01 Month 24 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Gene mutation analysis:

1. Gene mutation of FGF-FGFR pathway
2. Any new candidates of biomarker


Management information

Registered date

2014 Year 01 Month 24 Day

Last modified on

2022 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015138


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name