UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Detection of circulating tumor DNA by droplet digital PCR in patients with unresectable or recurrent gastric cancer
Title of the study (Brief title)	Detection of circulating tumor DNA in unresectable or recurrent gastric cancer patients
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Investigation of detectability of circulating tumor DNA in patients with unresectable or reucrrent gastric cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Investigation of detectability of circulating tumor DNA in patients with unresectable or reucrrent gastric cancer
Key secondary outcomes	Investigation of relation between ciruculating tumor DNA status and sensitivity to anticancer agents. Investigation of relation between ciruculating tumor DNA status and prognosis

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Detection of circulating tumor DNA by droplet digital PCR device
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	Histologically confirmed carcinoma of the stomach. Diagnosed as unresectable gastric cancer or recurrent gastric cancer. Appropriate informed consent obtained
Key exclusion criteria	Patients who are diagnosed as in appropriate for the study
Target sample size	20

Research contact person
Name of lead principal investigator	Masaki Nakamura
Organization	Wakayama medical university, School of Medicine
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0613
Email	twins@wakayama-med.ac.jp

Public contact
Name of contact person	Toshiaki Tsuji
Organization	Wakayama medical university, School of Medicine
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0613
Homepage URL
Email	totsuji@wakayama-med.ac.jp

Sponsor
Institute	Second Department of Surger, Wakayama medical university, School of Medicine
Institute
Department

Funding Source
Organization	Second Department of Surger, Wakayama medical university, School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	和歌山県立医科大学

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 18 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2017 Year 02 Month 02 Day
Anticipated trial start date	2017 Year 03 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 18 Day
Last modified on	2017 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030550