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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016332
Receipt No. R000018892
Scientific Title Preoperative evaluation of esophageal tumor invading aorta by measurement the CT level between this tumor - aorta with spine and prone position
Date of disclosure of the study information 2015/02/01
Last modified on 2015/01/25

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Basic information
Public title Preoperative evaluation of esophageal tumor invading aorta by measurement the CT level between this tumor - aorta with spine and prone position
Acronym Preoperative evaluation of esophageal tumor invading aorta by measurement the CT level between this tumor - aorta with spine and prone position
Scientific Title Preoperative evaluation of esophageal tumor invading aorta by measurement the CT level between this tumor - aorta with spine and prone position
Scientific Title:Acronym Preoperative evaluation of esophageal tumor invading aorta by measurement the CT level between this tumor - aorta with spine and prone position
Region
Japan

Condition
Condition Advanced thoracic esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish a more accurate and objective diagnostic method to judge the aortic wall invation in locally advanced thoracic esophageal cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between Tumor-Aorta distance and diagnosis of T4 by enhanced CT with spine and prone position
Key secondary outcomes

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 If the patients who will undergo chemotherapy or chemoradiotherapy, they have to be taken enhanced CT with spine and prone position twice (before and after therapy)
If the patients received surgery alone, they will be taken enhanced CT with spine and prone position just one time before operation.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)cT2-4(TNM UICC ver7)esophageal cancer patients to be performed esophagectomy
2)Histologically-proven esophageal squamous cell carcinoma or adenosquamous carcinoma with no prior treatment
3)Aged 20 to 80 years old
4)ECOG Performance status 0-2
5)Patients that can be supine and prone position
6)Patients who is able to take enhanced CT with organ function especially renal function
7)Written informed consent
Key exclusion criteria 1)Patients with severe complications
2)Any patients judged by the investigator to be unfit to participate in the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takushi Yasuda
Organization Department of surgery, Kindai univerisity
Division name Department of upper GI surgery
Zip code
Address 377-2 Ono-higashi Osaka-sayamashi, Osaka, Japan
TEL 072-366-0221
Email tyasuda@surg.med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumiko Tanaka
Organization Department of surgery, Kindai univerisity
Division name Department of upper GI surgery
Zip code
Address 377-2 Ono-higashi Osaka-sayamashi, Osaka, Japan
TEL 072-366-0221
Homepage URL
Email yumikomail1007@surg.med.kindai.ac.jp

Sponsor
Institute Department of surgery, Kindai univerisity
Institute
Department

Funding Source
Organization none
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
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
2015 Year 02 Month 01 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 Open public recruiting
Date of protocol fixation
2014 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 25 Day
Last modified on
2015 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018892

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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