UMIN-CTR Clinical Trial

Basic information
Public title	Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer
Acronym	Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer
Scientific Title	Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer
Scientific Title:Acronym	Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer
Region	Japan

Condition
Condition	Esophageal cancer, Esophago-gastric junctional cancer, Gastric cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To clarify clinical utility of detecting MRD and monitoring using ctDNA analysis in patients with gastrointestinal cancer who plan to undergo curative treatment.
Basic objectives2	Others
Basic objectives -Others	To evaluate clinical performance of ctDNA analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between RFS and ctDNA in patients with gastrointestinal cancer who underwent curative treatment (R0/R1 resection).
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) Esophageal cancer, esophago-gastric junction cancer, gastric cancer by clinical or histological diagnosis 2) Patients who plan to curative treatment 3) Age >= 20 year old. 4) Written informed consent obtained.
Key exclusion criteria	1) Patients with double cancer (excluding early or superficial cancers which can be curatively resected by endoscopic treatment) 2) Any other patients who are regarded as inadequate for study enrollment by principal investigators.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Kojima
Organization	National Cancer Center Hospital East
Division name	Department of Gastroenterology and Gastrointestinal Oncology
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL	04-7133-1111
Email	takojima@east.ncc.go.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Kotani
Organization	National Cancer Center Hospital East
Division name	Department of Gastroenterology and Gastrointestinal Oncology
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL	04-7133-1111
Homepage URL
Email	dkotani@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	National Cancer Center Hospital East
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	NCC IRB office
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel	03-3542-2511
Email	NCC_IRBoffice@ml.res.ncc.go.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	2020 Year 10 Month 05 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 10 Month 11 Day
Date of IRB
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design: Observational study

Management information
Registered date	2020 Year 10 Month 04 Day
Last modified on	2020 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043671

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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