UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026605 |
|---|---|
| Receipt number | R000030550 |
| Scientific Title | Detection of circulating tumor DNA by droplet digital PCR in patients with unresectable or recurrent gastric cancer |
| Date of disclosure of the study information | 2017/03/18 |
| Last modified on | 2017/03/18 14:40:08 |
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Basic information
Public title
Detection of circulating tumor DNA by droplet digital PCR in patients with unresectable or recurrent gastric cancer
Acronym
Detection of circulating tumor DNA in unresectable or recurrent gastric cancer patients
Scientific Title
Detection of circulating tumor DNA by droplet digital PCR in patients with unresectable or recurrent gastric cancer
Scientific Title:Acronym
Detection of circulating tumor DNA in unresectable or recurrent gastric cancer patients
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Investigation of detectability of circulating tumor DNA in patients with unresectable or reucrrent gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Investigation of detectability of circulating tumor DNA in patients with unresectable or reucrrent gastric cancer
Key secondary outcomes
Investigation of relation between ciruculating tumor DNA status and sensitivity to anticancer agents.
Investigation of relation between ciruculating tumor DNA status and prognosis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Detection of circulating tumor DNA by droplet digital PCR device
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Histologically confirmed carcinoma of the stomach.
Diagnosed as unresectable gastric cancer or recurrent gastric cancer.
Appropriate informed consent obtained
Key exclusion criteria
Patients who are diagnosed as in appropriate for the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Nakamura |
Organization
Wakayama medical university, School of Medicine
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama, Japan
TEL
073-441-0613
twins@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Tsuji |
Organization
Wakayama medical university, School of Medicine
Division name
Second 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
Second Department of Surger, Wakayama medical university, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Second Department of Surger, Wakayama medical university, School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
和歌山県立医科大学
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 18 | 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
Date of protocol fixation
| 2017 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 18 | 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
| 2017 | Year | 03 | Month | 18 | Day |
Last modified on
| 2017 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030550
