UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032785 |
|---|---|
| Receipt number | R000037398 |
| Scientific Title | Evaluation of computed tomography lymphography as a diagnostic modality for lymph node metastasis in esophageal cancer |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2023/06/10 18:33:00 |
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Basic information
Public title
Evaluation of computed tomography lymphography as a diagnostic modality for lymph node metastasis in esophageal cancer
Acronym
Lymph node metastatic diagnosis in esophageal cancer using CT lymphography
Scientific Title
Evaluation of computed tomography lymphography as a diagnostic modality for lymph node metastasis in esophageal cancer
Scientific Title:Acronym
Lymph node metastatic diagnosis in esophageal cancer using CT lymphography
Region
| Japan |
Condition
Condition
Superficial esophageal cancer
Classification by specialty
| Medicine in general | Gastroenterology | Surgery in general |
| Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate diagnostic accuracy of lymph node metastasis using CT lymphography in superficial esophageal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnostic accuracy of lymph node metastasis using CT lymphography in superficial esophageal cancer
Key secondary outcomes
1) sensitivity and specificity of lymph node diagnosis
2) Local lymph node recurrence within 3 years after surgery
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. superficial esophageal cancer from cervical to esopago-gastric junction (Sievert typeII) including suquamous cell carcinoma or adenocarcinoma
2. depth of tumor: submucosal layer in the endoscopic findings
Key exclusion criteria
1. kidney injury (eGFR<40ml/min)
2. dysfunction of the liver with esophageal varices
3. branchial asthma
4. pregnancy
5. allergy to iodine
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tangoku |
Organization
Institute of Biomedical Sciences
Tokushima University Graduate School
Division name
Department of Thoracic, Endocrine Surgery and Oncology
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima 770-8503, Japan
TEL
0886337143
tangoku@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoshida |
Organization
Institute of Biomedical Sciences Tokushima University Graduate School
Division name
Department of Thoracic, Endocrine Surgery and Oncology
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima 770-8503, Japan
TEL
0886337143
Homepage URL
http://www.tksbizan.com/medical/kyoushitsu.html
tyoshida1@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Thoracic, Endocrine Surgery and Oncology
Institute of Biomedical Sciences
Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Department of Thoracic, Endocrine Surgery and Oncology
Institute of Biomedical Sciences
Tokushima University Graduate School
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
Institute of Biomedical Sciences, Tokushima University Graduate School
Address
3-18-15, Kuramoto-cho, Tokushima
Tel
088-633-7143
tyoshida1@tokushima-u.ac.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
| 2018 | Year | 07 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 06 | Month | 09 | Day |
Other
Other related information
Prognostic power in CT lymphography compared with conventional CT is investigated in this study. Positive predictive value and negative predictive value are calculated.
Management information
Registered date
| 2018 | Year | 05 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037398
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
