UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of measurement of circulating tumor DNA during neoadjuvant chemotherapy for esophageal cancer
Title of the study (Brief title)	A prospective study of measurement of circulating tumor DNA during neoadjuvant chemotherapy for esophageal cancer
Region	Japan

Condition
Condition	resectable advanced esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose is determination of theraputic effect on esophageal cancer patients who underwent neoadjuvant chemotherapy by measurement of circulating tumor DNA using droplet digital PCR device and prediction of high risk group of recurrence cancer.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The correlation of the amount of circulating tumor DNA before and after neoadjuvant chemotherapy and the relapse-free survival
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	The patients are planned to undergo neoadjuvant chemotherapy and subsequent surgery for resectable advanced esophageal cancer.
Key exclusion criteria	The patients follow our protocol.
Target sample size	40

Research contact person
Name of lead principal investigator	Toshiaki Tsuji
Organization	Wakayama medical university
Division name	2nd department of surgery
Address	811-1 Kimiidera Wakayama, Japan
TEL	073-441-0613
Email	totsuji@wakayama-med.ac.jp

Public contact
Name of contact person	Toshiaki Tsuji
Organization	Wakayama medical university
Division name	2nd department of surgery
Address	811-1 Kimiidera Wakayama, Japan
TEL	073-441-0613
Homepage URL
Email	totsuji@wakayama-med.ac.jp

Sponsor
Institute	Wakayama medical university
Institute
Department

Funding Source
Organization	research expense
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 09 Month 05 Day
Anticipated trial start date	2017 Year 11 Month 01 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	nothing

Management information
Registered date	2017 Year 11 Month 01 Day
Last modified on	2017 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034035