UMIN-CTR Clinical Trial

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
Institute	St. Marianna University School of Medicine
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015138