UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016332 |
|---|---|
| Receipt number | 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 | 2024/02/04 21:07:04 |
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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
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
yumikomail1007@surg.med.kindai.ac.jp
Sponsor or person
Institute
Department of surgery, Kindai univerisity
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2014 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
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
| 2024 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018892
