UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029788 |
|---|---|
| Receipt number | R000034035 |
| Scientific Title | A prospective study of measurement of circulating tumor DNA during neoadjuvant chemotherapy for esophageal cancer |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2017/11/01 14:22:34 |
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Basic information
Public title
A prospective study of measurement of circulating tumor DNA during neoadjuvant chemotherapy for esophageal cancer
Acronym
A prospective study of measurement of circulating tumor DNA during neoadjuvant chemotherapy for esophageal cancer
Scientific Title
A prospective study of measurement of circulating tumor DNA during neoadjuvant chemotherapy for esophageal cancer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Toshiaki Tsuji |
Organization
Wakayama medical university
Division name
2nd department of surgery
Zip code
Address
811-1 Kimiidera Wakayama, Japan
TEL
073-441-0613
totsuji@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Tsuji |
Organization
Wakayama medical university
Division name
2nd department of surgery
Zip code
Address
811-1 Kimiidera Wakayama, Japan
TEL
073-441-0613
Homepage URL
totsuji@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
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)
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
| 2017 | Year | 11 | 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
| 2017 | Year | 09 | Month | 05 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034035
