UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038043 |
|---|---|
| Receipt number | R000043356 |
| Scientific Title | A multicenter retrospective study on evaluation of the risk of lymph node metastasis using CRP genetic polymorphism in pT1cN0 thoracic esophageal squamous cell carcinoma |
| Date of disclosure of the study information | 2019/09/19 |
| Last modified on | 2022/03/21 12:23:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A multicenter retrospective study on evaluation of the risk of lymph node metastasis using CRP genetic polymorphism in pT1cN0 thoracic esophageal squamous cell carcinoma
Acronym
Evaluation of the risk of lymph node metastasis using CRP genetic polymorphism in thoracic esophageal cancer
Scientific Title
A multicenter retrospective study on evaluation of the risk of lymph node metastasis using CRP genetic polymorphism in pT1cN0 thoracic esophageal squamous cell carcinoma
Scientific Title:Acronym
Evaluation of the risk of lymph node metastasis using CRP genetic polymorphism in thoracic esophageal cancer
Region
| Japan |
Condition
Condition
pT1cN0 thoracic esophageal squamous cell carcinoma
Classification by specialty
| Medicine in general | Gastroenterology | Surgery in general |
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the diagnostic ability for the risk of lymph node metastasis using CRP genetic polymorphism in patients with pT1cN0 thoracic esophageal squamous cell carcinoma.
Basic objectives2
Others
Basic objectives -Others
To evaluate the diagnostic ability for the risk of lymph node metastasis using CRP genetic polymorphism
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Negative predictive value to diagnose lymph node metastasis
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. pT1a-MM (ly+ and/or v+) or pT1b, cN0M0 primary thoracic squamous cell esophageal carcinoma.
2. Performed esophagectomy with 2 or 3-field lymph node adenectomy after 2007.
3. Examined lymph node metastasis pathologically.
3. Patients obtained informed consents.
4. Patients who can collect blood at the time of study.
Key exclusion criteria
1. Received neoadjuvant therapy.
2. Had double cancers diagnosed 3 years before or 2 years after esophagectomy.
3. Within 2 years after esophagectomy.
4. Had prior surgery in mediastimun.
Target sample size
645
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Motoyama |
Organization
Akita University
Division name
Graduate School of Medicine
Zip code
010-8543
Address
1-1-1 Hondo, Akita
TEL
018-834-1111
motoyama@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Motoyama |
Organization
Akita University
Division name
Graduate School of Medicine
Zip code
010-8543
Address
1-1-1 Hondo, Akita
TEL
018-834-1111
Homepage URL
motoyama@doc.med.akita-u.ac
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Independent Ethics Committee of Tohoku University Hospital
Address
1-1 Seiryocho, Aobaku, Sendai
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
| 2019 | Year | 09 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 25 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 02 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 30 | Day |
Other
Other related information
A multicenter retrospective study
In this study, we analyze CRP genetic polymorphism using blood sample.
Management information
Registered date
| 2019 | Year | 09 | Month | 18 | Day |
Last modified on
| 2022 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043356
